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Tirzepatide clinical trials

ClinicalTrials.gov lists 234 registered trials of Tirzepatide: 120 recruiting or about to, 25 running, 82 completed, 53 in phase 3, 45 with results posted. Recruiting sites are in United States, China, Australia, Canada, United Kingdom, Germany. The largest is Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk (887,132 people).

234registered trials

120recruiting now

25running

82completed

53in phase 3

45with results posted

Recruiting: 120Running: 25Completed: 82Stopped or withdrawn: 4Status unknown: 3234trials
  • Recruiting 120
  • Running 25
  • Completed 82
  • Stopped or withdrawn 4
  • Status unknown 3

Where Tirzepatide is in testing

Registered trials by phase. Phase 3 trials are the large ones that decide approval.

5Early phase 1First doses in people
32Phase 1Safety and dosing
64Phase 2Does it work?
53Phase 3Large confirmatory trials
40Phase 4After approval
40Not phasedObservational and other

Timeline

Each bar runs from a trial's start to its planned end; faded bars have no end date. Click a bar to open the trial.

2026202720282029203020312032Tirzepatide for the Treatment of Cannabis Use Disorder · Recruiting · Phase 2 · 6 people · 2027-03-01 to 2028-06-30Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients · Recruiting · No phase · 80 people · 2027-02-01 to 2027-06Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial · Recruiting · Phase 3 · 70 people · 2027-01 to 2028-12Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer · Recruiting · Phase 2 · 40 people · 2027-01 to 2029-03Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity · Recruiting · Phase 2 · 40 people · 2026-12 to 2028-12Trial of Tirzepatide for the Treatment of Cannabis Use Disorder · Recruiting · Phase 2 · 100 people · 2026-11-15 to 2028-03-15A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin · Recruiting · Phase 2 · 240 people · 2026-11-06 to 2027-09-28Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer · Recruiting · Early phase 1 · 15 people · 2026-11-01 to 2028-05-01A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer · Recruiting · Phase 2 · 55 people · 2026-11-01 to 2029-10-31Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) · Recruiting · No phase · 364 people · 2026-11 to 2027-10A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity · Recruiting · Phase 3 · 660 people · 2026-10-01 to 2028-02-16Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial · Recruiting · Phase 2, Phase 3 · 256 people · 2026-10-01 to 2028-12-01Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder · Recruiting · Phase 2 · 228 people · 2026-10-01 to 2031-07-01Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib · Recruiting · Phase 1 · 30 people · 2026-10 to 2030-06Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation · Recruiting · No phase · 40 people · 2026-10 to 2028-02Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial · Recruiting · Phase 2, Phase 3 · 726 people · 2026-09-20 to 2028-05-31Tirzepatide for Treatment of CCCA · Recruiting · Phase 2 · 20 people · 2026-09-15 to 2028-05-25A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity · Recruiting · Phase 1 · 18 people · 2026-09-11 to 2026-12Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide · Recruiting · Phase 4 · 150 people · 2026-09-07 to 2027-05-31Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients · Recruiting · Phase 4 · 710 people · 2026-09-01 to 2029-09-01Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008) · Recruiting · Phase 4 · 20 people · 2026-09 to 2027-09Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS) · Recruiting · Phase 3 · 150 people · 2026-09 to 2029-12GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD · Recruiting · Phase 2 · 30 people · 2026-08-28 to 2028-08-15A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight · Recruiting · Phase 1 · 84 people · 2026-08-27 to 2027-06Tirzepatide in Idiopathic Intracranial Hypertension Trial · Recruiting · Phase 4 · 60 people · 2026-08-25 to 2027-08An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder · Recruiting · Phase 2 · 45 people · 2026-08-19 to 2030-02-01Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese · Recruiting · Phase 2 · 224 people · 2026-08-15 to 2027-08-15Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients · Recruiting · No phase · 52 people · 2026-08-12 to 2027-01-12Incretin Therapies in Obesity-related HFpEF · Recruiting · Phase 4 · 50 people · 2026-08-07 to 2029-04Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial · Recruiting · Phase 2 · 168 people · 2026-08-01 to 2028-03-01Tirzepatide in the Treatment of Cannabis Use Disorder · Recruiting · Phase 3 · 15 people · 2026-08-01 to 2028-07-31Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF · Recruiting · Phase 4 · 602 people · 2026-08-01 to 2029-08-01A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants · Recruiting · Phase 2 · 60 people · 2026-08 to 2027-07The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) · Recruiting · Phase 3 · 24 people · 2026-08 to 2026-12Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay. · Recruiting · Phase 4 · 160 people · 2026-07-27 to 2027-08-10Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion · Recruiting · Phase 2 · 34 people · 2026-07-27 to 2028-07-31AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes · Recruiting · Phase 4 · 285 people · 2026-07-20 to 2027-10-31Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity · Recruiting · Phase 3 · 60 people · 2026-07-18 to 2027-06-11Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes · Recruiting · Phase 2 · 44 people · 2026-07-07 to 2027-12-31Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy · Recruiting · Phase 4 · 40 people · 2026-07 to 2028-07-01
RecruitingRunningCompletedStopped or withdrawnStatus unknownTodayNewest 40 of 234 trials

Where trials are recruiting

Countries with sites in trials that are recruiting now.

33 more countries.

Recruiting now 120

Tirzepatide for the Treatment of Cannabis Use Disorder

Not yet recruitingPhase 26 peopleRandomizedBrigham and Women's Hospital2027-03-01 → 2028-06-30

Studying: Cannabis Use Disorder · NCT07265752

About this trial

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.

Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients

Not yet recruiting80 peopleNanjing First Hospital, Nanjing Medical University2027-02-01 → 2027-06🇨🇳 China

Studying: Obesity / Overweight · NCT07847515

About this trial

This is an observational cohort study. The primary objective is to analyze the dynamic changes in gut microbiota and metabolic profiles in obese patients treated with Tirzepatide. A total of 80 participants will be enrolled: 40 normal-weight controls (NW group) and 40 obese patients receiving Tirzepatide as part of their routine clinical care (OB-T group). Fecal samples for 16S rRNA sequencing and blood samples for metabolic markers will be collected at baseline and after 3 months. Changes in gut microbiota diversity and composition will be correlated with improvements in glucose and lipid met…

Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Not yet recruitingPhase 370 peopleRandomizedUniversidade do Porto2027-01 → 2028-12🇵🇹 Portugal

Studying: Obesity · NCT07829198

About this trial

Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health. Participants who had bariatric surgery at least one year ago and still have obesity with insufficient weight loss will be randomly assigned, like a coin flip, to receive either tirzepatide or a placebo (an inactive injection that looks the same). Neither participants nor study staff will know who is receiving which treatment. Participan…

Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer

Not yet recruitingPhase 240 peopleRandomizedUNC Lineberger Comprehensive Cancer Center2027-01 → 2029-03🇺🇸 United States

Studying: Endometrial Cancer, Endometrial Intraepithelial Neoplasia, Grade 1 Endometrial Endometrioid Carcinoma · NCT07078838

About this trial

The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to their post-intervention hysterectomy specimens. It was hypothesized that tirzepatide may help fight tumors in two ways: indirectly, by improving the body's overall metabolic health, and directly, by acting on abnormal cells in the uterus, such as those found in endometrial intra…

Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

Not yet recruitingPhase 240 peopleRandomizedRoyal North Shore Hospital2026-12 → 2028-12

Studying: Type 1 Diabetes Mellitus, Overweight and Obesity · NCT06180616

About this trial

This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control …

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

Not yet recruitingPhase 2100 peopleRandomizedNational Institute on Drug Abuse (NIDA)2026-11-15 → 2028-03-15

Studying: Cannabis Use Disorder · NCT07468552

About this trial

The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.

A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin

Not yet recruitingPhase 2240 peopleRandomizedCSPC Ouyi Pharmaceutical Co., Ltd.2026-11-06 → 2027-09-28🇨🇳 China

Studying: T2DM (Type 2 Diabetes Mellitus) · NCT07796477

About this trial

This study is a multicenter, randomized, double-blind, placebo and active-controlled, dose-finding phase 2 study aimed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SYH2069 Injection in participants with Type 2 Diabetes Mellitus (T2DM) inadequate glycemic control with diet and exercise alone or metformin monotherapy. The study consists of four periods: a 2-week screening period, a 3-week run-in period, a 28-week treatment period and a 3-week safety follow-up period. A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c lev…

Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer

Not yet recruitingEarly phase 115 peopleMilton S. Hershey Medical Center2026-11-01 → 2028-05-01🇺🇸 United States

Studying: Grade 1 Endometrial Endometrioid Carcinoma, Endometrial Intraepithelial Neoplasia, Metabolic Comorbidities · NCT07812636

About this trial

This single-arm study will evaluate the feasibility, safety, and preliminary efficacy of tirzepatide in combination with standard levonorgestrel intrauterine device (LNG-IUD) therapy in patients with endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD. Treatment decisions will remain at the discretion of the treating physician. The primary objective is to evaluate pathologic response at approxi…

A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer

Not yet recruitingPhase 255 peopleNational Cancer Institute (NCI)2026-11-01 → 2029-10-31🇺🇸 United States

Studying: Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma · NCT07349641

About this trial

This phase II trial studies whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) improves pathologic response (absence of cancer cells in tissue samples after treatment) in women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or grade 1 endometrial cancer who are overweight or obese. Endometrial cancer occurrence has continued to rise in the United States. Over half of endometrial cancer cases are thought to be attributable to being overweight and obese, and the risk relationship appears to be weight dependent. AH/EIN is …

Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)

Not yet recruiting364 peopleDr. Md. Alimur Reza2026-11 → 2027-10🇧🇩 Bangladesh

Studying: Obesity · NCT07099742

About this trial

This is a prospective, multicenter, real-world study conducted in Bangladesh to assess the effectiveness and safety of Tirzepatide compared to structured lifestyle interventions, including dietary modifications and exercise, in obese adults with or without Type 2 Diabetes Mellitus (T2DM). The study aims to determine whether treatment with Tirzepatide results in superior weight reduction outcomes compared to lifestyle-based approaches. Adult participants (≥18 years) with a body mass index (BMI) ≥25 kg/m² and no prior exposure to GLP-1 receptor agonists will be enrolled at the discretion of the…

A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity

Not yet recruitingPhase 3660 peopleRandomizedPfizer2026-10-01 → 2028-02-16🇺🇸 United States

Studying: Obesity, Overweight and/or Obesity, Overweight, Treatment Of Obesity · NCT07845500

About this trial

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes. Participants will be in the study for about 11 months.

Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial

Not yet recruitingPhase 2, Phase 3256 peopleRandomizedWoolcock Institute of Medical Research2026-10-01 → 2028-12-01🇦🇺 Australia

Studying: Sleep Apnoea, Obesity & Overweight, Sleep Apnea Syndrome, Obstructive · NCT07846865

About this trial

When used, continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnea (OSA), a condition that is mainly caused by overweight and obesity. However, CPAP is plagued by poor adherence and high rates of discontinued use leaving most patients undertreated and at risk of serious health complications. This study aims to test whether new effective weight loss pharmacotherapy is superior to CPAP for alleviating OSA and improving health outcomes.

Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

Not yet recruitingPhase 2228 peopleRandomizedUniversity of Texas Southwestern Medical Center2026-10-01 → 2031-07-01🇺🇸 United States

Studying: Methamphetamine Use Disorder · NCT07825857

About this trial

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD. Participants will undergo study procedures over 32 weeks, including: 1. completing self-assessments 2. undergo brief physical and review of medical and psychiatric history 3. provide urine and blood samples 4. medica…

Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib

Not yet recruitingPhase 130 peopleUniversity of Chicago2026-10 → 2030-06🇺🇸 United States

Studying: Lung Cancer · NCT07782359

About this trial

The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement. This study seeks to evaluate its potential to mitigate side effects while preserving the therapeutic efficacy of lorlatinib.

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

Recruiting40 peopleThe University of Texas at Dallas2026-10 → 2028-02🇺🇸 United States

Studying: Drug Discontinuation, Substance Use Disorders, Eating Behavior Changes, Tirzepatide · NCT07387796

About this trial

The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. Specifically, the study aims to examine how a short pause in tirzepatide affects hunger, mood, sleep, and daily functioning; how stopping and restarting tirzepatide alters brain chemistry and brain responses to food-related images; and how these changes relate to health measures such as quality of life and emotional well-bein…

Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

Not yet recruitingPhase 2, Phase 3726 peopleRandomizedyifang zhu2026-09-20 → 2028-05-31🇨🇳 China

Studying: Acute Ischemic Stroke (AIS) · NCT07734792

About this trial

Acute ischemic stroke caused by blockage of a large artery in the brain is one of the leading causes of death and long-term disability worldwide. For patients with this type of stroke, endovascular thrombectomy (EVT), a procedure that removes the blood clot and restores blood flow to the brain, has become the standard treatment. However, even when blood flow is successfully restored, many patients continue to experience disability because of ongoing brain injury caused by inflammation, oxidative stress, and damage to brain cells after the stroke. This study aims to evaluate whether tirzepatid…

Tirzepatide for Treatment of CCCA

RecruitingPhase 220 peopleJohns Hopkins University2026-09-15 → 2028-05-25🇺🇸 United States

Studying: Central Centrifugal Cicatricial Alopecia (CCCA) · NCT07734870

About this trial

The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are: * Does tirzepatide improve the symptoms and signs of active CCCA? * Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring? * Does tirzepatide promote hair regrowth? Participants will: * Inject tirzepatide once a week for 12 months. * Visit the clinic for scalp examinations, photographs, and other health assessments. * Have scalp…

A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

RecruitingPhase 118 peopleRandomizedEli Lilly and Company2026-09-11 → 2026-12🇺🇸 United States

Studying: Diabetes Mellitus, Type 1, Overweight, Obesity · NCT07803744

About this trial

The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity. Participation in this study will last about 8 weeks, including screening and follow-up.

Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide

RecruitingPhase 4150 peopleRandomizedTechnical University of Munich2026-09-07 → 2027-05-31🇩🇪 Germany

Studying: Obesity (BMI>30) · NCT07777575

About this trial

Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects. The aim of this clinical trial is to examine the effects of resistance training versus standard of care on contractile thigh muscle volume in patients receiving the dual glucose-dependent insulinotropic polypep…

Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients

Not yet recruitingPhase 4710 peopleRandomizedYunlong Wang2026-09-01 → 2029-09-01

Studying: Atrial Fibrillation, Obesity & Overweight, Catheter Ablation · NCT07715929

About this trial

Obese patients with atrial fibrillation (AF) have a high recurrence rate after catheter ablation, even at experienced centers. Weight reduction improves post-ablation outcomes, but lifestyle measures alone are difficult to sustain. Tirzepatide, a once-weekly GIP/GLP-1 dual receptor agonist, produces greater weight loss than GLP-1 monotherapy and may confer additional cardiometabolic benefits. This multicenter, randomized, open-label, parallel-group, superiority trial evaluates whether adding standardized tirzepatide treatment to a structured lifestyle intervention - compared with the lifestyle…

Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

Not yet recruitingPhase 420 peopleRandomizedUniversity of North Carolina, Chapel Hill2026-09 → 2027-09🇺🇸 United States

Studying: Pouch, Ileal, Pouches, Ileoanal, Bowel Diseases, Inflammatory · NCT07756359

About this trial

The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy. The main question it aims to answer is: Does Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch Participants will: Visit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.

Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

Not yet recruitingPhase 3150 peopleRandomizedEli Lilly and Company2026-09 → 2029-12🇧🇪🇮🇱🇮🇹🇲🇽 Belgium, Israel, Italy, Mexico +6 more

Studying: Obesity · NCT07817875

About this trial

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD

Not yet recruitingPhase 230 peopleRandomizedThe Cleveland Clinic2026-08-28 → 2028-08-15🇺🇸 United States

Studying: COPD, Obesity & Overweight, Sarcopenia · NCT07747805

About this trial

Chronic obstructive pulmonary disease (COPD) is associated with systemic inflammation, obesity-related metabolic dysfunction, skeletal muscle impairment, and progressive decline in lung function. While obesity has historically been viewed as protective in COPD, emerging evidence suggests that excess adiposity and adipokine dysregulation, particularly elevated leptin levels, contribute to chronic inflammation, impaired muscle function, and worse clinical outcomes. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated anti-inflammatory, metabolic, and potential muscle-preserving…

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight

RecruitingPhase 184 peopleRandomizedAscletis Pharma (China) Co., Limited2026-08-27 → 2027-06🇺🇸 United States

Studying: Chronic Weight Management · NCT07842640

About this trial

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

Tirzepatide in Idiopathic Intracranial Hypertension Trial

RecruitingPhase 460 peopleRandomizedDuke University2026-08-25 → 2027-08🇺🇸 United States

Studying: Idiopathic Intracranial Hypertension (IIH) · NCT07191873

About this trial

This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline IC…

An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder

Enrolling by invitationPhase 245 peopleUniversity of Texas Southwestern Medical Center2026-08-19 → 2030-02-01🇺🇸 United States

Studying: Obesity, Methamphetamine Use Disorder, Cocaine Use Disorder, Stimulant Use Disorders · NCT07693608

About this trial

This open label pilot study will assess the feasibility and preliminary efficacy of tirzepatide which will be prescribed under its FDA approved weight management indication in adults with moderate or severe methamphetamine, cocaine or prescription stimulant use disorder (MUD) who also meet criteria for obesity or overweight with comorbidities. Up to 30 participants will receive 20 weeks of once weekly tirzepatide, followed by an observational follow up period. The study also incorporates MRI at seven time points to explore neural biomarkers associated with treatment response. All participants…

Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

Not yet recruitingPhase 2224 peopleRandomizedBiomed Industries, Inc.2026-08-15 → 2027-08-15🇦🇺🇳🇿🇺🇸 Australia, New Zealand, United States

Studying: Obesity and Overweight · NCT06732245

About this trial

A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women

Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients

Not yet recruiting52 peopleAkhtar Saeed Medical and Dental College2026-08-12 → 2027-01-12

Studying: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight · NCT07728318

About this trial

Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disease, often compounded by obesity, that leads to serious long-term health complications. While traditional antidiabetic medications help manage blood sugar, many patients continue to struggle with uncontrolled diabetes and excess weight. Newer therapies, such as dual GIP/GLP-1 receptor agonists like Tirzepatide, have demonstrated significant efficacy in lowering blood glucose (HbA1c) and body weight in global clinical trials. However, real-world data regarding its efficacy, safety, and patient-reported satisfaction in South Asian po…

Incretin Therapies in Obesity-related HFpEF

RecruitingPhase 450 peopleColumbia University2026-08-07 → 2029-04🇺🇸 United States

Studying: Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Obesity · NCT07554638

About this trial

The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially me…

Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial

Not yet recruitingPhase 2168 peopleRandomizedUniversitaire Ziekenhuizen KU Leuven2026-08-01 → 2028-03-01

Studying: Hormone-receptor-positive Breast Cancer, Early Breast Cancer · NCT07676331

About this trial

The CLARA trial is a phase II window-of-opportunity trial evaluating how a commonly used weight-loss medication (tirzepatide, a GLP-1/GIP receptor agonist) affects breast cancer biology, alone and in combination with standard hormone therapy (letrozole). The main goal is to determine whether tirzepatide, alone or combined with letrozole, reduces tumor cell growth.

Tirzepatide in the Treatment of Cannabis Use Disorder

Not yet recruitingPhase 315 peopleMcMaster University2026-08-01 → 2028-07-31🇨🇦 Canada

Studying: Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe · NCT07671248

About this trial

Cannabis is the most commonly used psychoactive substance in Canada. A sub-group of cannabis users develop Cannabis Use Disorder (CUD). CUD is a pattern of cannabis use that results in impairment in functioning, symptoms of tolerance, withdrawal, and distress. Several pharmacological and psychosocial interventions have been evaluated for their efficacy in treating CUD, however they lack high success rates. GLP-1RA's have shown promising results in reducing food and alcohol cravings and intake. Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonis…

Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF

Not yet recruitingPhase 4602 peopleRandomizedYunlong Wang2026-08-01 → 2029-08-01🇨🇳 China

Studying: Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFpEF), Tirzepatide · NCT07630454

About this trial

This multicenter, randomized, open-label, blinded-endpoint trial evaluates whether weekly subcutaneous tirzepatide for 12 months reduces atrial fibrillation (AF) recurrence after catheter ablation in adults with obesity and heart failure with preserved ejection fraction (HFpEF). HFpEF is diagnosed by direct intraprocedural measurement of mean left atrial pressure (mLAP ≥ 15 mmHg at rest) during the ablation procedure, providing a hemodynamically anchored, homogeneous study population free from the diagnostic ambiguities of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and E/e' in AF pa…

The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)

Not yet recruitingPhase 324 peopleRandomizedUniversity of Virginia2026-08 → 2026-12🇺🇸 United States

Studying: Obesity & Overweight · NCT07298915

About this trial

This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity. The main questions it will answer includes: * Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone * Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life Participants will: * Take a weight loss medication (tirzepatide) mo…

Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.

RecruitingPhase 4160 peopleLas Rías Medical Center2026-07-27 → 2027-08-10🌐 Paraguay

Studying: Obesity, Diabetes Mellitus, Type 2 · NCT07588438

About this trial

This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will be followed for 52 weeks with visits approximately every 6 weeks. Primary outcomes include percentage…

Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

RecruitingPhase 234 peopleRandomizedAlaa Sada2026-07-27 → 2028-07-31🇺🇸 United States

Studying: Mild Autonomous Cortisol Secretion (MACS), Adrenalectomy; Status · NCT07573163

About this trial

Mild Autonomous Cortisol Secretion (MACS) is a condition in which an adrenal gland produces excess cortisol and is associated with high blood pressure, diabetes, and weight gain. Surgical removal of the adrenal gland (adrenalectomy) is standard treatment, but some patients continue to have metabolic health problems after surgery. This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with adrenalectomy alone.

AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes

Not yet recruitingPhase 4285 peopleRandomizedThe First Affiliated Hospital of Anhui Medical University2026-07-20 → 2027-10-31🇨🇳 China

Studying: Obesity, Diabetes Mellitus, Type 2 · NCT07697391

About this trial

This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months. Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle…

Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity

Not yet recruitingPhase 360 peopleRandomizedShahid Beheshti University of Medical Sciences2026-07-18 → 2027-06-11

Studying: Heart Failure and Reduced Ejection Fraction, Obesity & Overweight, Tirzepatide · NCT07738276

About this trial

The goal of this clinical trial is to learn if tirzepatide works to improve physical function in adults with heart failure and obesity. It will also learn about the safety of tirzepatide. The main questions it aims to answer are: Does tirzepatide improve how far participants can walk in 6 minutes? Does tirzepatide improve heart failure symptoms and quality of life? What side effects do participants have when taking tirzepatide? Researchers will compare tirzepatide to a placebo (a look-alike substance that contains no drug) to see if tirzepatide improves physical function in people with heart…

Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

RecruitingPhase 244 peopleRandomizedVictor Chang Cardiac Research Institute2026-07-07 → 2027-12-31🇦🇺 Australia

Studying: Type 1 Diabetes Mellitus · NCT06820281

About this trial

This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.

Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

Not yet recruitingPhase 440 peopleRandomizedPost Graduate Institute of Medical Education and Research, Chandigarh2026-07 → 2028-07-01

Studying: Neuropathy, Small Fiber, Diabete Mellitus · NCT07706088

About this trial

Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration. Using tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM / NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotr…

Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV

Enrolling by invitationPhase 460 peopleNational Taiwan University Clinical Trial Center2026-06-25 → 2027-12🇹🇼 Taiwan

Studying: Human Immunodeficiency Virus (HIV), Metabolic Dysfunction Associated Steatotic Liver Disease, Dyslipidaemia, Diabetes Mellitus · NCT07707778

About this trial

This study is a pilot, open-lable, two-arm study. The investigators will enroll virally suppressed people living with HIV and obesity to evaluate the effect of tirzepatide on epigenetic aging, assessed by DNA methylation-based clocks using peripheral blood. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.

Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation

Not yet recruiting200 peopleRandomizedNational Taiwan University Hospital2026-06-16 → 2027-12-31🇹🇼 Taiwan

Studying: Atrial Fibrillation Ablation, Persistent Atrial Fibrillation, Obesity & Overweight · NCT07382024

About this trial

The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population. The main questions it aims to answer are: 1. Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring? 2. Does tirzepatide lead to gre…

Tirzepatide in MetALD

RecruitingPhase 2120 peopleRandomizedNational Institute on Alcohol Abuse and Alcoholism (NIAAA)2026-06-11 → 2027-07-30🇺🇸 United States

Studying: Metabolic Alcohol-associated Liver Disease, Alcohol Use Disorder · NCT07046819

About this trial

Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: To test Tirzepatide in people with AUD and MetALD. Eligibility: People aged 21 years and older with AUD and MetALD. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have…

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

RecruitingPhase 430 peopleWeill Medical College of Cornell University2026-06-08 → 2027-12-03🇺🇸 United States

Studying: Obesity (Disorder), Breast Cancer · NCT07257484

About this trial

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be com…

Multi-Site Trial of Tirzepatide for Smoking Cessation

RecruitingPhase 2300 peopleRandomizedUniversity of Southern California2026-06-05 → 2028-03🇺🇸 United States

Studying: Smoking Cessation, Smoking Behaviors · NCT07602699

About this trial

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. Participants will att…

Tirzepatide in the Treatment of Endometrial Cancer

Not yet recruitingPhase 230 peopleRutgers, The State University of New Jersey2026-06-01 → 2028-01

Studying: Endometrial Cancer · NCT07605247

About this trial

This study is looking for a better way to treat pre-cancer or early-stage cancer in the lining of the uterus in women who are also overweight. Everyone in the study will receive the standard treatment, a Progesterone IUD (LNG-IUD). This device is put in the uterus and releases hormones to help fight the disease. We will add a new medicine, Tirzepatide, for some people. Tirzepatide is a shot that helps with weight loss and overall health. You will be placed into one of two groups by chance (like flipping a coin): 1. Group 1: You get the Progesterone IUD PLUS the Tirzepatide shot. 2. Group 2: …

GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes

Recruiting42 peopleIstanbul Saglik Bilimleri University2026-05-30 → 2026-11-30🌐 Turkey (Türkiye)

Studying: Obesity, Sarcopenia · NCT07858864

About this trial

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual GLP-1/GIP agonists such as semaglutide and tirzepatide produce marked weight loss in people with obesity, with reported reductions of about 15-20%. Rapid weight loss may reduce not only fat mass but also lean body mass and skeletal muscle mass, raising concern about sarcopenia and sarcopenic obesity. Evidence in non-diabetic obese individuals is limited and inconsistent. This prospective descriptive study will assess muscle mass, muscle strength, physical performance and sarcopenia risk in non-diabetic obese adults starting GLP-1 R…

A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD

RecruitingPhase 2204 peopleRandomizedRegeneron Pharmaceuticals2026-05-22 → 2030-03-15🇺🇸 United States

Studying: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) · NCT07527910

About this trial

This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein. The goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat. The study is looking at: * How well ALN-PN…

Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)

RecruitingPhase 1176 peopleRandomizedNational Institute on Alcohol Abuse and Alcoholism (NIAAA)2026-05-20 → 2031-12-31🇺🇸 United States

Studying: Alcohol Use Disorder (AUD) · NCT07559500

About this trial

Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD). Objective: To learn how the brains of people with AUD respond to a GLP-1 drug. Eligibility: People aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed. Design: This study consists of Part 1 and Part 2. Part 1 (Im…

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

RecruitingPhase 2, Phase 3105 peopleRandomizedMcGill University Health Centre/Research Institute of the McGill University Health Centre2026-05-19 → 2028-01🇨🇦🇨🇭 Canada, Switzerland

Studying: Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D, T1DM · NCT07284511

About this trial

This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose. Tirzepatide is a…

Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Recruiting68 peopleRandomizedDasman Diabetes Institute2026-05-15 → 2029-05-15🌐 Kuwait

Studying: Obesity · NCT07574723

About this trial

The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can reduce gastrointestinal side effects while maintaining weight-loss effectiveness in adults with obesity without diabetes. The main questions it aims to answer are: 1. Does flexible, symptom-guided titration reduce nausea and vomiting compared with standard per-label titration? 2. Does flexible titration achieve weight loss comparable to standard titration? Researchers will compare standard per-label titration with a click-based, symptom-guided titration approach to assess…

Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health

Not yet recruitingPhase 2180 peopleRandomizedFirst Affiliated Hospital of Wenzhou Medical University2026-05-01 → 2026-08-12

Studying: Obesity-related Male Infertility · NCT07179120

About this trial

Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving. What will happen …

GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity

Recruiting200 peopleChina-Japan Friendship Hospital2026-05-01 → 2028-05-01🇨🇳 China

Studying: Obesity · NCT07633639

About this trial

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor a…

CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

Not yet recruiting30 peopleJULIO GRANADOS MONTIEL2026-05 → 2027-11🇲🇽 Mexico

Studying: Psoriatic Arthritis, Osteoarthitis, Knee, Diabetes (DM) · NCT07567378

About this trial

CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1/GIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is ope…

AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)

Not yet recruitingPhase 4400 peopleRandomizedHuazhong University of Science and Technology2026-04-30 → 2028-09-30🇨🇳 China

Studying: Overweight or Obesity; Type 2 Diabetes, Weight Loss Maintenance · NCT07555730

About this trial

This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance. The study consists of two phases: a 20-week lead-in phase, during which all participants will receive weekly subcutaneous tirzepatide at the maximum tolerated dose (MTD), followed by a 52-week intervention phase. Participants who meet the randomization criteria after the lead-in phase will be randomly assigned to either AI-assisted multi-domain lifestyle intervention or tirzepatide 5 mg

GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study

Not yet recruiting2,310 peopleNoom Inc.2026-04-30 → 2029-05🇺🇸 United States

Studying: Obesity & Overweight, Weight Loss, Preventative Health, Body Weight · NCT07588984

About this trial

This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement. FLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Plus Microdose). THRIVE is a nested 2-arm prospective study comparing a Proactive Health program to a…

Tirzepatide in Obesity-Driven Endometrial Cancer

RecruitingEarly phase 120 peopleUNC Lineberger Comprehensive Cancer Center2026-04-27 → 2028-07🇺🇸 United States

Studying: Endometrial Cancer, Obesity · NCT07065552

About this trial

LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen. The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect ef…

Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity

RecruitingPhase 220 peopleSt. Jude Children's Research Hospital2026-04-23 → 2027-11🇺🇸 United States

Studying: Acute Lymphoblastic Leukemia, Obesity · NCT07228741

About this trial

This is a 28-week, single-arm, open-label phase II clinical trial evaluating the combination of Tirzepatide and remote, supervised, tailored resistance exercise training to achieve weight loss in adult survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. Primary Objective(s): • To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise (three sessions per week) in adult survivors of childhood ALL with obesity or overweight (BMI ≥27 kg/m2…

Precision Obesity Medicine: Genetic Prediction of Response to GLP-1/GIP Agonists.

Recruiting220 peopleNational and Kapodistrian University of Athens2026-04-22 → 2027-01-30🇬🇷 Greece

Studying: Obesity (Disorder), Anti-obesity Agents, Precision Medicine · NCT07653412

About this trial

Obesity is a chronic multifactorial disease with a strong genetic component. Although glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists, such as tirzepatide, are highly effective treatments for obesity, substantial inter-individual variability in weight loss response remains. Genetic factors may contribute to these differences in treatment outcomes. The aim of this prospective cohort study is to investigate whether a Genetic Risk Score (GRS) and selected obesity-related single nucleotide po…

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

Not yet recruiting1,700 peopleRadboud University Medical Center2026-04-01 → 2026-07-01🇳🇱 Netherlands

Studying: Overweight , Obesity, Obesity (Disorder) · NCT07504172

About this trial

Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice. In this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are: * How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching? * How i…

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

RecruitingPhase 220 peopleThe University of Texas Health Science Center at San Antonio2026-04-01 → 2027-04-01🇺🇸 United States

Studying: Obesity Prevention, Sarcopenia in Elderly, Cardiovascular Function, GLP - 1 · NCT06811324

About this trial

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obe…

Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs

Recruiting120 peopleRandomizedTri-Service General Hospital (TSGH)2026-03-31 → 2028-09-30🇹🇼 Taiwan

Studying: Obesity and Metabolic Syndrome · NCT07589322

About this trial

This randomized, open label, head to head clinical trial directly compares tirzepatide and semaglutide in adults with obesity and metabolic syndrome (N=120, age 20-65, 1:1 randomization). Participants undergo deep phenotyping at baseline, 6 months, and 12 months, including DXA (regional fat, lean mass, and BMD), MRI PDFF (liver fat), 7 site skinfold thickness, grip strength, fasting biochemistry, and AI processed 12 lead ECGs. Centralized biobanking of serum, plasma, and PBMCs enables targeted and discovery multi omic analyses.

Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes

RecruitingPhase 2372 peopleRandomizedHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.2026-03-31 → 2027-02-04🇨🇳 China

Studying: Obesity · NCT07521631

About this trial

This is a 56-week randomized, open-label, controlled study evaluating the efficacy and safety of the HDM1005 compared to tirzepatide in adults with obesity but without diabetes. Eligible participants will be screened and randomized to different dose group of HDM1005 or the tirzepatide group at a ratio of 1:1:1 :1, HDM1005 or tirzepatide will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Recruiting45 peopleRandomizedNHS Greater Glasgow and Clyde2026-03-09 → 2028-02🇬🇧 United Kingdom

Studying: Psoriatic Arthritis (PsA), Obesity & Overweight · NCT07443956

About this trial

This is a trial to find out how weight loss (achieved by the use of tirzepatide) or ixekizumab treatment affects the characteristics of skin, joint and fat tissues in patients with Psoriatic Arthritis, Psoriasis and obesity/overweight BMI \>=27. Participants will be allocated either Tirzepatide, Ixekizumab or both. Samples of joint tissue, fat and skin will be taken at the start of the study and week 12. Blood and urine samples will also be taken. The primary objective will be to assess the changes seen in the joint, fat and skin tissue samples 12 weeks after starting the medications (additi…

A Study to Evaluate ALN-2232 in Participants With Obesity

RecruitingPhase 1, Phase 2156 peopleRandomizedAlnylam Pharmaceuticals2026-03-02 → 2027-04-27🇨🇦 Canada

Studying: Obesity · NCT07463846

About this trial

The purpose of this study is to: * evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity

DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies

Not yet recruitingPhase 4112 peopleRandomizedCambridge University Hospitals NHS Foundation Trust2026-03 → 2027-04🇬🇧 United Kingdom

Studying: Cardiovascular Diseases · NCT07483801

About this trial

What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels. There are three dif…

Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay

Not yet recruiting300 peopleLABORATORIOS INDUFAR2026-03 → 2026-10🌐 Paraguay

Studying: Obesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities · NCT07492563

About this trial

This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A. in 300 patients with obesity treated at the Obesity Unit of Hospital de Clínicas in Paraguay over 12 months. The primary objective is to assess the safety profile through monitoring adverse events. Secondary objectives include evaluating weight loss, metabolic parameters improvement, and treatment satisfaction in real-world clinical practice.

Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors

RecruitingPhase 120 peopleMassachusetts General Hospital2026-02-24 → 2027-03-31🇺🇸 United States

Studying: Colorectal Cancer Prevention, Colorectal Adenoma · NCT07095517

About this trial

This research study is an open-label Phase 1 Exploratory/Pilot clinical trial to measure the effects of the incretin mimetic, tirzepatide, on tissue, urine, blood, and microbiome biomarkers associated with colorectal cancer risk and to understand the feasibility of this precision prevention trial approach for a future larger study.

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)

RecruitingPhase 32,539 peopleRandomizedHudson Biotech2026-02-02 → 2027-02-14🇨🇳 China

Studying: Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities · NCT07481747

About this trial

This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.

Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure

Not yet recruiting15 peopleShahid Beheshti University of Medical Sciences2026-02-01 → 2026-04-01🇮🇷 Iran

Studying: Obesity · NCT07176663

About this trial

Diabetes management presents a complex clinical scenario marked by several challenges, especially in chronic kidney failure. These include navigating potential drug interactions between oral antidiabetic therapies and other agents. Furthermore, these patients may experience various adverse drug effects, such as lactic acidosis, electrolyte abnormalities such as hypomagnesemia, fluid retention, and lipid derangements, which can further augment overall morbidity. Consequently, many patients receive insulin. However, prolonged intensive insulin therapy may be linked to several adverse outcomes, i…

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

RecruitingPhase 2310 peopleRandomizedT. John Winhusen, PhD2026-01-29 → 2027-09-30🇺🇸 United States

Studying: Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe · NCT06651177

About this trial

The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.

Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)

Not yet recruitingPhase 246 peopleRandomizedSouth West Sydney Local Health District2026-01-15 → 2027-05-15🇦🇺 Australia

Studying: Alcohol Use Disorder (AUD), Overweight or Obese, Comorbidities and Coexisting Conditions · NCT07292519

About this trial

The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight/obesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) …

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

RecruitingPhase 430 peopleShahid Beheshti University of Medical Sciences2026-01-01 → 2026-07🇮🇷 Iran

Studying: Tirzepatide · NCT07423247

About this trial

Post-transplant obesity is a common complication after kidney transplantation, largely attributed to recovery from uremia, increased appetite, sedentary lifestyle, and long-term corticosteroid exposure. Obesity in kidney transplant recipients increases the risk of cardiovascular disease, post-transplant diabetes mellitus (PTDM), and may contribute to graft injury through hyperfiltration-related mechanisms, potentially leading to reduced graft survival. Current approaches for weight management in transplant recipients, including lifestyle modification, are often insufficient, while bariatric su…

A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults

Recruiting60 peopleRandomizedCambridge University Hospitals NHS Foundation Trust2026-01 → 2027-01🇬🇧 United Kingdom

Studying: Hypertension, Obesity & Overweight · NCT07364175

About this trial

Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom. Obesity is also a serious and ongoing epidemic, with global obesity rates having more than tripled in men and doubled in women, since 1975. In the United Kingdom, 64% of the adult population are overweight or obese. Hypertension and obesity share a well-established association, with obesity being responsible for the development of hypertension in 40-78% of cases. In young adults, this link between body size and blood pressure (BP) is much stronger that in older adults. Since…

Tirzepatide and Muscle Outcomes in Obesity

Recruiting30 peopleRandomizedUniversity Medical Centre Ljubljana2026-01 → 2026-12🌐 Slovenia

Studying: Obesity (Disorder) · NCT07373834

About this trial

This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following trea…

Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

Not yet recruiting48 peopleRandomizedIstanbul Galata University2025-12-29 → 2026-10🌐 Turkey (Türkiye)

Studying: Obesity · NCT07319975

About this trial

Obesity is a growing global health problem that affects people of all ages. It can lead to serious health issues such as cardiovascular disease, insulin resistance, inflammation, and reduced physical function. New medications, including GLP-1 receptor agonists like semaglutide and dual GLP-1/GIP agonists like tirzepatide, have been shown to help people lose significant weight. However, some of this rapid weight loss may come from a reduction in muscle mass rather than fat. Losing muscle can lower physical performance, impair metabolic health, and increase the risk of developing sarcopenic obes…

A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese

RecruitingPhase 4198 peopleRandomizedUniversity of Bonn2025-12-09 → 2028-12🇩🇪 Germany

Studying: Polycystic Ovary Syndrome (PCOS), Obesity & Overweight · NCT07326111

About this trial

This clinical study examines whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. Tirzepatide is already approved for the treatment of diabetes and obesity, but its effects on ovarian dysfunction in PCOS are not yet known. Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner. The goal of the study is to demonstrate that tirzepatide, at the maximum tolerated dose, is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity…

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)

RecruitingPhase 43,000 peopleRandomizedEli Lilly and Company2025-11-24 → 2029-07🇬🇧 United Kingdom

Studying: Obesity · NCT07247084

About this trial

The purpose of this study is to evaluate tirzepatide within a real-world setting to assess body weight loss and incidence of type 2 diabetes in adults without diabetes who have obesity and at least one weight-related comorbid condition. Eligible participants must be registered patients at a participating site. Participation in the study will last about 260 weeks.

Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity

RecruitingPhase 263 peopleRandomizedMassachusetts General Hospital2025-11-05 → 2028-12-31🇺🇸 United States

Studying: Obesity · NCT05933499

About this trial

In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which may have negative effects on health by lessening improvements in glucose and insulin levels, reducing resting metabolic rate, and increasing the risk of falls and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may help maximize loss of fat mass while maintaining muscle mass whe…

Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial

RecruitingPhase 260 peopleRandomizedCity of Hope Medical Center2025-11-05 → 2028-04-09🇺🇸 United States

Studying: Prostate Carcinoma, Recurrent Prostate Carcinoma · NCT07202247

About this trial

This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related meta…

Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity

RecruitingPhase 1, Phase 2104 peopleRandomizedIkaria Bioscience Pty Ltd2025-11-04 → 2027-02-15🇦🇺 Australia

Studying: Obesity &Amp; Overweight · NCT07245771

About this trial

Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

RecruitingPhase 34,500 peopleRandomizedEli Lilly and Company2025-10-15 → 2030-08🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +30 more

Studying: Metabolic Dysfunction-Associated Steatotic Liver Disease · NCT07165028

About this trial

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 wee…

GLP-1R Actions on Muscle and the Skeleton

RecruitingPhase 450 peopleRandomizedPennington Biomedical Research Center2025-10-09 → 2027-02-01🇺🇸 United States

Studying: Musculoskeletal Abnormalities, Obesity, Sarcopenic Obesity, Osteoporosis · NCT07154719

About this trial

The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.

Tirzepatide for Alcohol Use Disorder

RecruitingPhase 242 peopleRandomizedUniversity of Southern California2025-10-06 → 2026-08-31🇺🇸 United States

Studying: Alcohol Use Disorder, Obesity and Overweight, Alcohol · NCT06994338

About this trial

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

RecruitingPhase 2105 peopleRandomizedJohns Hopkins University2025-09-17 → 2027-12-01🇺🇸 United States

Studying: Obesity and Overweight, Binge Eating Disorder · NCT06847399

About this trial

The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.

Study of Tirzepatide for Recovery and Alcohol Use Management

RecruitingPhase 220 peopleRandomizedBrigham and Women's Hospital2025-09-15 → 2027-03-01🇺🇸 United States

Studying: Alcohol Use Disorder (AUD) · NCT06727331

About this trial

This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.

Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

RecruitingPhase 232 peopleRandomizedUniversity of Michigan2025-09-08 → 2029-09🇺🇸 United States

Studying: Lipodystrophy, Partial · NCT07091734

About this trial

This study aims to see if the clinical use of Tirzepatide in patients with lipodystrophy (a rare disorder associated with abnormal loss of the body's fat tissue) may lead to improved diabetes mellitus control and lowering of participant's triglycerides through the reduction of caloric intake. Study Hypothesis: \- The clinical use of Tirzepatide in patients with lipodystrophy may lead to favorable outcomes through the reduction of caloric intake.

Tirzepatide Use in People With Obesity and Type 1 Diabetes

RecruitingPhase 460 peopleRandomizedDasman Diabetes Institute2025-07-31 → 2028-02-25🌐 Kuwait

Studying: Type1diabetes, Obesity · NCT07096908

About this trial

Tirzepatide, a gut hormone-based medication, has shown promising results in treating obesity, with \~22% weight loss and mild side effects. However, patients with type 2 diabetes typically experience only about 15% weight loss with tirzepatide, despite tolerating the medication well. Its effects in people with both obesity and type 1 diabetes remain largely unknown. Although tirzepatide is not approved for glycemic control in type 1 diabetes, it is licensed for obesity treatment in Gulf and Europe. In Kuwait, more than a quarter of people with type 1 diabetes also have obesity, presenting a u…

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

RecruitingEarly phase 18 peopleUniversity of New Mexico2025-06-30 → 2026-10🇺🇸 United States

Studying: MASLD, Obesity · NCT06934642

About this trial

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD. Participants will be asked to: * Take tirzepatide for 12 months. * Come in for clinic visits every 3 months. * Have blood drawn at…

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

RecruitingPhase 3290 peopleRandomizedEli Lilly and Company2025-06-26 → 2028-05🇦🇹🇧🇪🇧🇷🇧🇬 Austria, Belgium, Brazil, Bulgaria +18 more

Studying: Crohn's Disease, Obesity or Overweight · NCT06937099

About this trial

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

RecruitingPhase 3350 peopleRandomizedEli Lilly and Company2025-06-26 → 2028-04🇦🇹🇧🇪🇧🇷🇧🇬 Austria, Belgium, Brazil, Bulgaria +19 more

Studying: Ulcerative Colitis, Obesity or Overweight · NCT06937086

About this trial

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity

Recruiting66 peopleRandomizedSecond Affiliated Hospital, Zhejiang University, School of Medicine2025-06-02 → 2027-04-02🇨🇳 China

Studying: Adults With Simple Obesity · NCT07293325

About this trial

This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Changes in "biological (epigenetic) age" will be assessed using the iWatchAge DNA methylation age test, while simultaneously monitoring improvements in aging-related biomarkers such as inflammatory factors, metabolic parameters, and body composition. The aim is to determine whether incretin-based therapies can reverse or slow obesity-related accel…

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

RecruitingPhase 260 peopleRandomizedWashington University School of Medicine2025-05-13 → 2028-05🇺🇸 United States

Studying: Crohn Disease (CD) · NCT06976853

About this trial

The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research tea…

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

RecruitingPhase 2108 peopleRandomizedAnders Fink-Jensen, MD, DMSci2025-05-05 → 2028-08-01🇩🇰 Denmark

Studying: Alcohol Use Disorder, Alcohol Abuse/Dependence, Alcohol Dependence, Alcoholism · NCT06939088

About this trial

Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide/GLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) …

Tirzepatide in PWS, HO and GNSO

RecruitingPhase 436 peopleGrace Kim2025-05-01 → 2026-06🇺🇸 United States

Studying: Prader-Willi Syndrome, Hypothalamic Obesity, Obesity/Therapy · NCT06901245

About this trial

This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.

Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women

Enrolling by invitationPhase 430 peopleRandomizedMayo Clinic2025-05-01 → 2026-12-31🇺🇸 United States

Studying: Obesity, Menopause · NCT07057310

About this trial

In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. The goal is to determine the effect of weight loss induced by the new generation of GLP-1 receptor agonists on physical function, aging biomarkers, and vascular function in postmenopausal women with obesity.

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

RecruitingPhase 2100 peopleRandomizedThe Cleveland Clinic2025-04-08 → 2026-12-31🇺🇸 United States

Studying: Atrial Fibrillation, Obesity · NCT06802081

About this trial

This is a single center randomized double blind controlled study of patients (BMI ≥ 27 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo. It is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.

A Study of BGM0504 in Participants With Obesity

RecruitingPhase 290 peopleRandomizedBrightGene Bio-Medical Technology Co., Ltd.2025-04-03 → 2026-01-11🇨🇳 China

Studying: Obesity · NCT06911203

About this trial

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

2024 Tirzepatide-Bariatric Surgery

RecruitingPhase 450 peopleRandomizedMarlene Starr2025-03-27 → 2026-12-31🇺🇸 United States

Studying: Obesity and Obesity-related Medical Conditions, Bariatric Surgery · NCT06721507

About this trial

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-da…

A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

RecruitingPhase 4200 peopleEli Lilly and Company2025-03-19 → 2028-05🇺🇸 United States

Studying: Psoriasis, Overweight or Obesity · NCT06857942

About this trial

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

RecruitingPhase 2126 peopleRandomizedUniversity of Colorado, Denver2025-03-06 → 2029-06-30🇺🇸 United States

Studying: Autosomal Dominant Polycystic Kidney, Obesity · NCT06582875

About this trial

The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring care…

Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

RecruitingPhase 424 peopleRandomizedUniversity of Miami2025-03-05 → 2027-03-05🇺🇸 United States

Studying: Crohn Disease · NCT06774079

About this trial

The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.

GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes

RecruitingPhase 342 peopleRandomizedUniversity of Bern2025-02-14 → 2026-06🇨🇭 Switzerland

Studying: Type 1 Diabetes (T1D) · NCT06630585

About this trial

Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only \~30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin in T1D. This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide (GIP/GLP-1RA) to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control.

Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide

RecruitingPhase 4104 peopleRandomizedStanford University2025-01-13 → 2027-12-15🇺🇸 United States

Studying: Diabetes Mellitus, Type 2, Diabetes, Type 2 Diabetes, Pre Diabetes · NCT06657209

About this trial

This study is to investigate how adipocyte (fat cell) function and fat distribution differ between individuals with normal-weight type 2 diabetes (NWD), those with overweight type 2 diabetes (OWD), and normal-weight controls without diabetes (NWC). The study will assess whether adipocyte-directed therapies, specifically pioglitazone and tirzepatide, can improve insulin resistance, adipocyte function, and fat distribution in individuals with NWD. By analyzing the biological mechanisms underlying adipocyte dysfunction, the study aims to provide insights into novel treatment strategies for improv…

A Study of a Weight Loss Intervention in People With Endometrial Cancer

RecruitingEarly phase 136 peopleMemorial Sloan Kettering Cancer Center2024-12-19 → 2027-12🇺🇸 United States

Studying: Endometrial Cancer · NCT06751589

About this trial

The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.

A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus

RecruitingPhase 1, Phase 2180 peopleRandomizedArrowhead Pharmaceuticals2024-12-04 → 2027-09-17🇦🇺🇨🇦🌐🇳🇿 Australia, Canada, Georgia, New Zealand

Studying: Obesity · NCT06700538

About this trial

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).

Tirzepatide Weight Loss for MRD+ Early Breast Cancer

RecruitingPhase 248 peopleBaylor Research Institute2024-11-26 → 2029-08-31🇺🇸 United States

Studying: Breast Cancer, Breast Neoplasms, Breast Cancers · NCT06517212

About this trial

This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)

RecruitingPhase 4352 peopleRandomizedUniversity of Melbourne2024-11-19 → 2027-05🇦🇺 Australia

Studying: Obesity, Knee Osteoarthritis, Osteoarthritis, Knee · NCT06191848

About this trial

This is a trial of tirzepatide in people with obesity and knee osteoarthritis. The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.

Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

RecruitingPhase 3256 peopleRandomizedThe University of Texas Health Science Center at San Antonio2024-11-07 → 2029-04-30🇺🇸 United States

Studying: Type 2 Diabetes (Adult Onset) · NCT06246799

About this trial

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

RecruitingPhase 240 peopleRutgers, The State University of New Jersey2024-10-30 → 2027-09-30🇺🇸 United States

Studying: Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer · NCT06518837

About this trial

This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA…

Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

RecruitingPhase 140 peopleRandomizedUniversity of Colorado, Denver2024-10-11 → 2027-09-01🇺🇸 United States

Studying: Obesity, Adolescent Obesity, Body-Weight Trajectory, Weight Loss Trajectory · NCT06575738

About this trial

The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone. The study also plans to learn more about whether a medication (semaglutide or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

RecruitingPhase 4124 peopleRandomizedTina Vilsbøll2024-10-01 → 2027-03-20🇩🇰 Denmark

Studying: Coronary Artery Disease, Coronary Microvascular Dysfunction, Overweight or Obesity, Stable Angina Pectoris · NCT06606821

About this trial

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese indiv…

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

RecruitingPhase 3300 peopleRandomizedEli Lilly and Company2024-06-03 → 2027-10🇦🇷🇦🇺🇨🇦🇫🇷 Argentina, Australia, Canada, France +8 more

Studying: Obesity, Weight Gain · NCT06439277

About this trial

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing th…

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

RecruitingPhase 4120 peopleRandomizedMatthew J. Budoff2024-01-02 → 2025-12🇺🇸 United States

Studying: Type II Diabetes, Atherosclerosis · NCT05708859

About this trial

A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

RecruitingPhase 21,481 peopleRandomizedEli Lilly and Company2023-11-17 → 2027-09🇦🇷🇺🇸 Argentina, United States

Studying: Obesity, Overweight · NCT06143956

About this trial

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity

RecruitingPhase 266 peopleRandomizedStanford University2023-11-09 → 2028-06🇺🇸 United States

Studying: Obesity, Overweight and Obesity, Overweight · NCT05912621

About this trial

Obesity, affecting 40% of US adults and costing 173b annually, represents a significant health care burden (1). It is associated with increased risk for multiple chronic diseases including hypertension, type 2 diabetes (T2D), cardiovascular disease, and NAFLD, as well as cancer, osteoarthritis, and obstructive sleep apnea. The investigators plan to test the hypothesis that tirzepatide, a dual GLP/GIP agonist, improves metabolic health (insulin resistance and regional fat distribution and cardiovascular risk profile) not only by inducing weight loss via GLP1-agonism, but also via beneficial cel…

Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD

Recruiting250 peopleCardenal Herrera University2023-09-15 → 2027-07-31🇪🇸 Spain

Studying: Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2 · NCT07309094

About this trial

Chronic kidney disease (CKD) is the progressive damage to kidney function, associated with an increased risk of cardiovascular diseases, such as stroke or myocardial infarct, particularly in the most severe stages of CKD, in which the patient requires dialysis. Several risk factors are reported for CKD, such as diabetes mellitus, obesity and hypertension. One of the most increasingly recognized risk factors is the fat tissue malfunction, known as adiposopathy. The accumulation of fat tissue around the organs in conditions of obesity or diabetes accelerates the production of pro-inflammatory fa…

Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes

RecruitingPhase 4150 peopleRandomizedNanjing First Hospital, Nanjing Medical University2022-03-15 → 2023-12-31🇨🇳 China

Studying: Type 2 Diabetes Mellitus · NCT05553093

About this trial

The effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus. Effects of Tirzepatide on the occurrence and development of cognitive impairment in diabetic patients and its associated pattern of changes in brain neural network characteristics.

Active, not recruiting 25

A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity

Active, not recruitingPhase 4344 peopleEli Lilly and Company2026-02-27 → 2027-07🇮🇳 India

Studying: Diabetes Mellitus, Type 2, Obesity, Overweight · NCT07438444

About this trial

The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.

A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus

Active, not recruitingPhase 140 peopleEli Lilly and Company2026-01-14 → 2026-11🇸🇬 Singapore

Studying: Diabetes Mellitus, Type 2, Overweight, Obesity · NCT07299084

About this trial

The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.

The Long COVID Treatment Trial

Active, not recruitingPhase 21,000 peopleRandomizedScripps Translational Science Institute2025-10-30 → 2026-12🇺🇸 United States

Studying: Long COVID · NCT07128082

About this trial

The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.

Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions

Active, not recruitingPhase 430 peopleRandomizedMayo Clinic2025-10-01 → 2028-01-31🇺🇸 United States

Studying: Obesity · NCT06801015

About this trial

The purpose of this study is to compare effects of weekly SQ semaglutide 2.4mg SQ, SQ tirzepatide 10mg, and placebo administered for 24 weeks on GES measured repeatedly at baseline, 16 weeks, 24 weeks, 28 weeks, 4 weeks after stopping the medication, and accommodation and satiation at 24 weeks compared to baseline.

GLP-1s to Enhance Lasting Optimal Weight

Active, not recruitingPhase 440 peopleWake Forest University Health Sciences2025-07-07 → 2027-10-30🇺🇸 United States

Studying: Obesity · NCT06861439

About this trial

The goal of this study is to examine how tirzepatide affects body composition, bone health, and physical performance in older adults over a nine-month period. Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

Active, not recruitingPhase 3465 peopleRandomizedEli Lilly and Company2025-05-12 → 2026-11🇦🇷🇧🇷🇨🇦🇨🇿 Argentina, Brazil, Canada, Czechia +6 more

Studying: Type 1 Diabetes, Obesity, Overweight · NCT06962280

About this trial

The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

Active, not recruitingPhase 2285 peopleRandomizedHoffmann-La Roche2025-05-05 → 2026-09-03🇵🇱🇪🇸🇬🇧🇺🇸 Poland, Spain, United Kingdom, United States

Studying: Obesity, Overweight, Overweight With One Weight Related Comorbidity · NCT06965413

About this trial

The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatme…

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Active, not recruitingPhase 3905 peopleRandomizedEli Lilly and Company2025-04-25 → 2026-11🇦🇷🇧🇷🇩🇰🇫🇷 Argentina, Brazil, Denmark, France +8 more

Studying: Type 1 Diabetes, Obesity, Overweight · NCT06914895

About this trial

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Active, not recruitingPhase 4200 peopleEli Lilly and Company2025-03-06 → 2027-08🇵🇷🇺🇸 Puerto Rico, United States

Studying: Psoriatic Arthritis, Overweight or Obesity · NCT06864026

About this trial

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Sequential Therapy Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)

Active, not recruitingPhase 4150 peopleRandomizedThe Cleveland Clinic2025-03-01 → 2027-04-28🇺🇸 United States

Studying: Obesity · NCT06854614

About this trial

This is a prospective, pragmatic, 21 month, single-center, randomized, 2-phased, open-label, parallel-group trial comparing the use of enhanced lifestyle changes (ELC) in two different therapy: sequential vs continuation of AOM. The ELC consists of a medically supervised and comprehensive weight loss program (Cleveland Clinic's Department of Endocrinology, Diabetes and Metabolism's Integrated Weight Management Program). In the first phase (9 months) of the study, all participants will receive Tirzepatide 15 mg (option #1) or Semaglutide 2.4 mg if Tirzepatide is not tolerated. In the second pha…

Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Active, not recruitingPhase 4140 peopleRandomizedAli Aminian2025-01-29 → 2027-07-01🇺🇸 United States

Studying: Obesity and Obesity-related Medical Conditions · NCT06803888

About this trial

The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the litera…

Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction

Active, not recruiting26,000 peopleBrigham and Women's Hospital2025-01-01 → 2025-11-30🇺🇸 United States

Studying: Type 2 Diabetes, Heart Failure · NCT06980623

About this trial

This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.

Efficacy and Safety of Tirzepatide for Weight Management

Active, not recruitingPhase 3440 peopleChittagong Medical College2025-01-01 → 2026-06-30🇧🇩 Bangladesh

Studying: Obesity and Obesity-related Medical Conditions · NCT06918405

About this trial

The goal of this study is to learn if tirzepatide helps people manage their weight safely. It will include adults in Bangladesh who are overweight or obese, with or without type 2 diabetes. The main questions it aims to answer are: Does tirzepatide help people lose weight? What side effects do people experience while taking tirzepatide? All participants will: Receive tirzepatide as a weekly injection, starting at 2.5 mg and gradually increasing to 15 mg. Continue the treatment for 52 weeks (12 months). Visit the clinic for regular checkups and tests. Researchers will measure changes in …

Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs

Active, not recruiting120 peopleNazarbayev University2024-12-18 → 2025-07-01🌐 Kazakhstan

Studying: Heart Failure, Diabete Type 2, Arterial Hypertension · NCT07303556

About this trial

This clinical study aims to improve the diagnosis and treatment of cardiovascular diseases in Kazakhstan by Implementing Metabolic Correction with Glucagon-Like Peptide-1 (GLP-1). These medicines are called incretin-based therapies and include GLP-1 receptor agonists and a newer dual therapy that targets both GIP and GLP-1 receptors. Such medications have already shown benefits in lowering blood sugar, reducing body weight, improving blood pressure, and lowering the risk of serious heart complications. Cardiovascular diseases and diabetes are among the most common health problems in Kazakhsta…

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Active, not recruitingPhase 3800 peopleRandomizedEli Lilly and Company2024-11-01 → 2026-11🇦🇷🇩🇪🇵🇱🇵🇷 Argentina, Germany, Poland, Puerto Rico +1 more

Studying: Obesity · NCT06662383

About this trial

The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial

Active, not recruitingPhase 2, Phase 330 peopleRandomizedVanderbilt University Medical Center2024-10-30 → 2027-01-01🇺🇸 United States

Studying: Severe Obesity, Obesity, BMI Greater Than 30 · NCT06162715

About this trial

The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Gastric Bypass Surgery.

A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

Active, not recruitingPhase 2252 peopleRandomizedEli Lilly and Company2024-10-21 → 2026-01-16🇺🇸 United States

Studying: Obesity, Overweight · NCT06643728

About this trial

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.

A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

Active, not recruitingPhase 2108 peopleRandomizedPalatin Technologies, Inc2024-08-05 → 2025-02-05🇺🇸 United States

Studying: Obesity · NCT06565611

About this trial

This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of bremelanotide (BMT) used in combination with tirzepatide therapy in the treatment of obesity in subjects with a BMI ranging from 30.0 to 45.0 kg/m2 (inclusive).

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Active, not recruitingPhase 3160 peopleRandomizedEli Lilly and Company2023-10-16 → 2026-06-02🇨🇦🇨🇿🇮🇱🇮🇹 Canada, Czechia, Israel, Italy +2 more

Studying: Obesity, Overweight · NCT06075667

About this trial

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Participants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Active, not recruitingPhase 2414 peopleRandomizedEli Lilly and Company2023-09-21 → 2026-01-08🇦🇷🇲🇽🌐🇺🇸 Argentina, Mexico, Turkey (Türkiye), United States

Studying: Type 2 Diabetes, Obesity · NCT06037252

About this trial

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Anti-obesity Pharmacotherapy and Inflammation

Active, not recruiting30 peopleLouisiana State University Health Sciences Center in New Orleans2023-06-01 → 2026-01-30🇺🇸 United States

Studying: Obesity · NCT05756764

About this trial

This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

Active, not recruitingPhase 1564 peopleRandomizedOrsoBio, Inc2023-04-22 → 2026-09🇳🇿 New Zealand

Studying: Healthy Subjects, Obesity, Type 2 Diabetes · NCT05822544

About this trial

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

Active, not recruitingPhase 315,374 peopleRandomizedEli Lilly and Company2022-10-11 → 2027-10🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +24 more

Studying: Obesity, Overweight · NCT05556512

About this trial

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Active, not recruitingPhase 4780 peopleRandomizedEli Lilly and Company2022-08-01 → 2025-10-21🇦🇷🇨🇦🇩🇪🇮🇱 Argentina, Canada, Germany, Israel +7 more

Studying: Type 2 Diabetes · NCT05433584

About this trial

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Completed 82

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

CompletedPhase 313,299 peopleRandomizedEli Lilly and Company2020-05-29 → 2025-06-12🇦🇷🇦🇺🇦🇹🇧🇪 Argentina, Australia, Austria, Belgium +27 moreResults posted

Studying: Type 2 Diabetes Mellitus · NCT04255433

About this trial

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

CompletedPhase 32,539 peopleRandomizedEli Lilly and Company2019-12-04 → 2022-04-01🇦🇷🇧🇷🇨🇳🇮🇳 Argentina, Brazil, China, India +6 moreResults posted

Studying: Overweight, Obesity · NCT04184622

About this trial

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

CompletedPhase 32,002 peopleRandomizedEli Lilly and Company2018-11-20 → 2021-01-22🇦🇷🇦🇺🇧🇷🇨🇦 Argentina, Australia, Brazil, Canada +11 moreResults posted

Studying: Type 2 Diabetes Mellitus · NCT03730662

About this trial

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

CompletedPhase 31,879 peopleRandomizedEli Lilly and Company2019-07-30 → 2021-01-28🇦🇷🇦🇺🇧🇷🇨🇦 Argentina, Australia, Brazil, Canada +5 moreResults posted

Studying: Type 2 Diabetes · NCT03987919

About this trial

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

CompletedPhase 31,444 peopleRandomizedEli Lilly and Company2019-04-01 → 2020-12-11🇦🇷🇦🇹🇬🇷🇭🇺 Argentina, Austria, Greece, Hungary +9 moreResults posted

Studying: Type 2 Diabetes Mellitus · NCT03882970

About this trial

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.

A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

CompletedPhase 31,428 peopleRandomizedEli Lilly and Company2020-10-19 → 2022-10-11🇦🇷🇧🇪🇧🇷🇨🇿 Argentina, Belgium, Brazil, Czechia +12 moreResults posted

Studying: Type 2 Diabetes · NCT04537923

About this trial

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

CompletedPhase 3938 peopleRandomizedEli Lilly and Company2021-03-29 → 2023-03-16🇦🇷🇧🇷🇮🇳🇯🇵 Argentina, Brazil, India, Japan +4 moreResults posted

Studying: Type 2 Diabetes, Overweight, Obesity · NCT04657003

About this trial

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

CompletedPhase 3917 peopleRandomizedEli Lilly and Company2019-12-09 → 2021-11-01🇦🇺🇨🇳🇮🇳🇰🇷 Australia, China, India, South KoreaResults posted

Studying: Type 2 Diabetes · NCT04093752

About this trial

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

CompletedPhase 3783 peopleRandomizedEli Lilly and Company2021-03-29 → 2023-04-25🇦🇷🇧🇷🇵🇷🇹🇼 Argentina, Brazil, Puerto Rico, Taiwan +1 moreResults posted

Studying: Obesity, Overweight · NCT04660643

About this trial

This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

CompletedPhase 3751 peopleRandomizedEli Lilly and Company2023-04-21 → 2024-11-13🇵🇷🇺🇸 Puerto Rico, United StatesResults posted

Studying: Obesity, Overweight · NCT05822830

About this trial

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

CompletedPhase 3731 peopleRandomizedEli Lilly and Company2021-04-20 → 2024-07-02🇦🇷🇧🇷🇨🇳🇮🇳 Argentina, Brazil, China, India +6 moreResults posted

Studying: Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF) · NCT04847557

About this trial

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

CompletedPhase 3579 peopleRandomizedEli Lilly and Company2021-03-29 → 2023-04-20🇦🇷🇧🇷🇵🇷🇺🇸 Argentina, Brazil, Puerto Rico, United StatesResults posted

Studying: Obesity, Overweight · NCT04657016

About this trial

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

CompletedPhase 3478 peopleRandomizedEli Lilly and Company2019-06-03 → 2020-10-05🇮🇳🇯🇵🇲🇽🇵🇷 India, Japan, Mexico, Puerto Rico +1 moreResults posted

Studying: Type 2 Diabetes Mellitus · NCT03954834

About this trial

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

CompletedPhase 3475 peopleRandomizedEli Lilly and Company2019-08-30 → 2020-12-22🇨🇿🇩🇪🇯🇵🇵🇱 Czechia, Germany, Japan, Poland +4 moreResults posted

Studying: Type 2 Diabetes · NCT04039503

About this trial

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

CompletedPhase 3469 peopleRandomizedEli Lilly and Company2022-06-21 → 2024-03-12🇦🇺🇧🇷🇨🇳🇨🇿 Australia, Brazil, China, Czechia +6 moreResults posted

Studying: Obstructive Sleep Apnea, Obesity · NCT05412004

About this trial

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

CompletedPhase 3443 peopleRandomizedEli Lilly and Company2019-03-30 → 2021-01-26🇯🇵 JapanResults posted

Studying: Type 2 Diabetes Mellitus · NCT03861039

About this trial

The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus

CompletedPhase 2318 peopleRandomizedEli Lilly and Company2017-05-24 → 2018-08-01🇵🇱🇵🇷🇸🇰🇺🇸 Poland, Puerto Rico, Slovakia, United StatesResults posted

Studying: Type 2 Diabetes Mellitus · NCT03131687

About this trial

The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

CompletedPhase 4282 peopleRandomizedEli Lilly and Company2022-11-30 → 2024-07-15🇧🇪🇩🇪🇲🇽🇷🇴 Belgium, Germany, Mexico, Romania +1 moreResults posted

Studying: Type 2 Diabetes · NCT05564039

About this trial

The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

CompletedPhase 3267 peopleRandomizedEli Lilly and Company2021-05-10 → 2023-06-24🇯🇵 JapanResults posted

Studying: Obesity · NCT04844918

About this trial

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

CompletedPhase 3257 peopleRandomizedEli Lilly and Company2023-02-05 → 2024-07-01🇨🇳 ChinaResults posted

Studying: Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease · NCT05691712

About this trial

The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.

A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

CompletedPhase 3210 peopleRandomizedEli Lilly and Company2021-09-01 → 2022-12-27🇨🇳 ChinaResults posted

Studying: Obesity, Overweight, Metabolism and Nutrition Disorder · NCT05024032

About this trial

This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

CompletedPhase 2190 peopleRandomizedEli Lilly and Company2019-11-19 → 2023-12-11🇧🇪🇫🇷🇮🇱🇮🇹 Belgium, France, Israel, Italy +6 moreResults posted

Studying: Nonalcoholic Steatohepatitis · NCT04166773

About this trial

The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

CompletedPhase 4152 peopleEli Lilly and Company2023-03-08 → 2023-10-31🇺🇸 United StatesResults posted

Studying: Type 2 Diabetes, Diabetes Mellitus, Type 2 · NCT05706506

About this trial

The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

CompletedPhase 1142 peopleRandomizedEli Lilly and Company2016-05-11 → 2017-06-26🇸🇬🇺🇸 Singapore, United StatesResults posted

Studying: Healthy, Type 2 Diabetes Mellitus (T2DM) · NCT02759107

About this trial

The main purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it. * How tirzepatide affects the levels of blood sugar. This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection jus…

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

CompletedPhase 1117 peopleRandomizedEli Lilly and Company2019-06-28 → 2021-04-08🇩🇪 GermanyResults posted

Studying: Diabetes Mellitus, Type 2 · NCT03951753

About this trial

This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.

A Study of Tirzepatide in Overweight and Very Overweight Participants

CompletedPhase 1114 peopleRandomizedEli Lilly and Company2020-08-24 → 2022-12-16🇺🇸 United StatesResults posted

Studying: Obesity, Overweight · NCT04311411

About this trial

The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

CompletedPhase 399 peopleRandomizedEli Lilly and Company2022-04-13 → 2024-07-30🇦🇺🇧🇷🇫🇷🇮🇳 Australia, Brazil, France, India +5 moreResults posted

Studying: Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D · NCT05260021

About this trial

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

CompletedPhase 165 peopleRandomizedEli Lilly and Company2023-04-03 → 2023-07-17🇺🇸 United StatesResults posted

Studying: Healthy · NCT05810597

About this trial

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

CompletedPhase 155 peopleRandomizedEli Lilly and Company2020-07-09 → 2022-05-26🇺🇸 United StatesResults posted

Studying: Obesity · NCT04081337

About this trial

This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.

A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

CompletedPhase 154 peopleRandomizedEli Lilly and Company2019-09-13 → 2020-04-03🇺🇸 United StatesResults posted

Studying: Healthy · NCT04050670

About this trial

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.

A Study of Tirzepatide (LY3298176) in Healthy Participants

CompletedPhase 152 peopleRandomizedEli Lilly and Company2017-12-19 → 2018-12-27🇺🇸 United StatesResults posted

Studying: Healthy · NCT03375463

About this trial

This study has four parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein. Part C: The purpose of Part C is to evaluate the safety and tolerability of…

A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

CompletedPhase 148 peopleRandomizedEli Lilly and Company2017-11-15 → 2018-05-29🇯🇵 JapanResults posted

Studying: Type 2 Diabetes Mellitus · NCT03322631

About this trial

The purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes the body to remove it. * How tirzepatide affects the levels of blood sugar. This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.

A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

CompletedPhase 147 peopleRandomizedEli Lilly and Company2019-08-19 → 2019-12-16🇸🇬 SingaporeResults posted

Studying: Healthy · NCT04004988

About this trial

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.

A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function

CompletedPhase 145 peopleRandomizedEli Lilly and Company2018-03-30 → 2019-08-19🇺🇸 United StatesResults posted

Studying: Renal Insufficiency, End Stage Renal Disease · NCT03482024

About this trial

The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

CompletedPhase 142 peopleRandomizedEli Lilly and Company2020-02-24 → 2022-01-25🇦🇹 AustriaResults posted

Studying: Diabetes Mellitus, Type 2, Hypoglycemia · NCT04050553

About this trial

The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.

A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

CompletedPhase 140 peopleEli Lilly and Company2020-02-26 → 2021-02-09🇺🇸 United StatesResults posted

Studying: Healthy · NCT04172987

About this trial

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.

A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

CompletedPhase 136 peopleEli Lilly and Company2020-09-15 → 2021-01-07🇺🇸 United StatesResults posted

Studying: Overweight, Obesity, Diabetes Mellitus, Type 2 · NCT04407234

About this trial

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.

A Study of Tirzepatide in Participants With Impaired Liver Function

CompletedPhase 132 peopleEli Lilly and Company2019-07-22 → 2020-09-22🇺🇸 United StatesResults posted

Studying: Hepatic Insufficiency · NCT03940742

About this trial

The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants. The study will last about two months and will include five visits to the study center.

A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

CompletedPhase 128 peopleRandomizedEli Lilly and Company2023-02-07 → 2025-01-16🇺🇸 United StatesResults posted

Studying: Obesity · NCT05696847

About this trial

The main purpose of this study is to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. The blood tests will be performed to investigate how the body processes the study drug in these participants. For each participant, the study will last about approximately 13 weeks excluding the screening period.

A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

CompletedPhase 124 peopleRandomizedEli Lilly and Company2020-10-21 → 2021-08-17🇨🇳 ChinaResults posted

Studying: Diabetes Mellitus, Type 2 · NCT04235959

About this trial

The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. The study will last about six or eight months for each participant.

A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

CompletedPhase 111 peopleEli Lilly and Company2023-07-31 → 2024-03-12🇺🇸 United StatesResults posted

Studying: Healthy · NCT05978713

About this trial

The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.

Study of Tirzepatide in Healthy Participants

CompletedPhase 16 peopleEli Lilly and Company2020-07-28 → 2020-10-02🇬🇧 United KingdomResults posted

Studying: Healthy · NCT04311424

About this trial

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 …

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Completed887,132 peopleBrigham and Women's Hospital2024-10-01 → 2025-07-15🇺🇸 United States

Studying: Type 2 Diabetes, Overweight, Cardiovascular (CV) Risk · NCT07096063

About this trial

Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Tirzepatide vs Semaglutide in Individuals at Cardiovascular Risk But Without Diabetes.

Completed100,000 peopleBrigham and Women's Hospital2026-02-10 → 2026-06-01🇺🇸 United States

Studying: Obesity, Overweight · NCT07619508

About this trial

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Completed60,000 peopleBrigham and Women's Hospital2026-01-27 → 2026-06-19🇺🇸 United States

Studying: Type 2 Diabetes, Overweight, ASCVD · NCT07417618

About this trial

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)

Completed49,065 peopleBrigham and Women's Hospital2025-09-19 → 2025-10-15🇺🇸 United States

Studying: Type2 Diabetes Mellitus, Atherosclerotic Cardiovascular Disease · NCT07203677

About this trial

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

Completed44,671 peopleBrigham and Women's Hospital2024-10-01 → 2025-07-30🇺🇸 United States

Studying: Type 2 Diabetes, Major Adverse Cardiac Events, Cardiovascular (CV) Risk · NCT07088718

About this trial

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction

Completed28,118 peopleBrigham and Women's Hospital2025-01-14 → 2025-06-01🇺🇸 United States

Studying: Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction · NCT06914141

About this trial

Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data

Completed11,265 peopleBrigham and Women's Hospital2025-01-14 → 2025-06-01🇺🇸 United States

Studying: Diabetes Mellitus, Type 2, Heart Failure With Preserved Ejection Fraction (HFPEF) · NCT06914154

About this trial

Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

CompletedPhase 31,024 peopleRandomizedNovo Nordisk A/S2024-01-16 → 2026-03-04🇦🇷🇦🇺🇨🇦🇨🇴 Argentina, Australia, Canada, Colombia +4 more

Studying: Type 2 Diabetes · NCT06221969

About this trial

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

CompletedPhase 31,023 peopleRandomizedNovo Nordisk A/S2024-11-05 → 2026-06-02🇦🇷🇦🇺🇧🇷🇨🇦 Argentina, Australia, Brazil, Canada +10 more

Studying: Diabetes Mellitus, Type 2 · NCT06534411

About this trial

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

CompletedPhase 3809 peopleRandomizedNovo Nordisk A/S2023-11-27 → 2025-12-08🇺🇸 United States

Studying: Obesity · NCT06131437

About this trial

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepati…

A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

CompletedPhase 2392 peopleRandomizedEli Lilly and Company2024-04-24 → 2025-12-15🇺🇸 United States

Studying: Obesity · NCT06373146

About this trial

The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.

A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

CompletedPhase 2367 peopleRandomizedEli Lilly and Company2024-09-20 → 2026-07-01🇦🇷🇺🇸 Argentina, United States

Studying: Obesity, Overweight · NCT06603571

About this trial

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

CompletedPhase 2354 peopleRandomizedNovo Nordisk A/S2024-03-18 → 2025-04-10🇦🇺🇯🇵🇺🇸 Australia, Japan, United States

Studying: Obesity · NCT06326060

About this trial

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.

Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants

CompletedPhase 2326 peopleRandomizedGan and Lee Pharmaceuticals, USA2025-02-24 → 2026-02-27🇺🇸 United States

Studying: Obesity and Overweight · NCT06737042

About this trial

This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

CompletedPhase 3281 peopleRandomizedEli Lilly and Company2024-09-30 → 2026-01-08🇵🇷🇺🇸 Puerto Rico, United States

Studying: Psoriasis, Obesity · NCT06588283

About this trial

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

CompletedPhase 3279 peopleRandomizedEli Lilly and Company2024-09-24 → 2025-11-18🇵🇷🇺🇸 Puerto Rico, United States

Studying: Psoriatic Arthritis, Obesity · NCT06588296

About this trial

The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriatic arthritis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients

Completed254 peopleAzienda Sanitaria Locale Napoli 2 Nord2025-02-01 → 2026-01-18🇮🇹 Italy

Studying: Obesity & Overweight, Weight Regain, Obesity, Morbid · NCT07382180

About this trial

This multicenter retrospective observational study evaluates the real-world use of tirzepatide in adult patients with post-bariatric weight regain and in patients with obesity undergoing preoperative management. The study analyzes changes in body weight and metabolic parameters, as well as treatment tolerability and safety, during routine clinical care. No experimental interventions are performed, and all patients receive tirzepatide as part of standard medical practice.

A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity

CompletedPhase 1188 peopleEli Lilly and Company2025-04-09 → 2026-01-19🇺🇸 United States

Studying: Overweight, Obesity · NCT06916065

About this trial

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it. There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts …

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan

CompletedPhase 4166 peopleEli Lilly and Company2024-10-11 → 2026-04-15🇸🇦🇦🇪 Saudi Arabia, United Arab Emirates

Studying: Type 2 Diabetes · NCT06635057

About this trial

The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.

Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial

CompletedPhase 3159 peopleRandomizedZagazig University2025-10-18 → 2026-03-17🇸🇦 Saudi Arabia

Studying: Obese Diabetics, Obese Non Diabetic · NCT07820111

About this trial

titel : Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial Abstract : Background: This study that highlights the different effects of most used three GLP-RA Dulaglutide, Semaglutide, Tirazepetide among diabetic and non -diabetic participant as the well-known fact that they don't have only weight recuing effect but also many different effects on metabolic process including insulin sensitivity, lipid profile and NASH. Materials and Methods: This is a randomized controlled study involving a total of 159 participants, divided …

Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity

Completed154 peopleGoztepe Prof Dr Suleyman Yalcın City Hospital2024-01-01 → 2026-03-30🌐 Turkey (Türkiye)

Studying: Steatosis of Liver, Metabolic Liver Injury, Obesity, Overweight · NCT07701005

About this trial

This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose \[TyG\] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk reduction related to metabolic dysfunction-associated steatotic liver disease (MASLD). Baseline and follow-up (minimum 12 weeks) clinical, anthropometric, and laboratory data from 154 patients treated at a single tertiary-care center in Turkey were analyzed. The study assessed whether…

Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

CompletedPhase 3150 peopleRandomizedZagazig University2025-11-14 → 2026-04-13🇸🇦 Saudi Arabia

Studying: Non-diabetec Obesity, Obesity (Disorder) · NCT07834398

About this trial

This randomized controlled trial evaluates the efficacy of three weekly GLP-1 receptor agonists (dulaglutide, semaglutide, and tirzepatide) in non-diabetic obese adults. 150 participants with BMI \>30 will be randomized into three groups and followed for 6 months to assess changes in weight, BMI, lipid profile, and liver functions.

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants

CompletedPhase 1148 peopleRandomizedLexaria Bioscience Corp.2024-12-04 → 2025-07-31🇦🇺 Australia

Studying: Type2diabetes · NCT06648031

About this trial

This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants.

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

CompletedPhase 2134 peopleRandomizedEli Lilly and Company2023-02-08 → 2026-07-06🇦🇹🇨🇦🇩🇰🇲🇽 Austria, Canada, Denmark, Mexico +2 more

Studying: Overweight, Obesity, Chronic Kidney Disease, Type 2 Diabetes · NCT05536804

About this trial

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.

A Study of LY3841136 in Japanese Participants With Obesity or Overweight

CompletedPhase 1128 peopleRandomizedEli Lilly and Company2024-04-15 → 2025-11-21🇯🇵 Japan

Studying: Obesity, Overweight · NCT06297616

About this trial

The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.

A Study of LY3841136 in Overweight and Obese Participants

CompletedPhase 196 peopleRandomizedEli Lilly and Company2024-04-03 → 2025-09-29🇺🇸 United States

Studying: Obesity, Overweight · NCT06345066

About this trial

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity

Completed91 peopleAzienda Sanitaria Locale Napoli 2 Nord2025-01-01 → 2026-06-01🇮🇹 Italy

Studying: Obese Adults, Hernia Abdominal Wall, Prehabilitation · NCT07638592

About this trial

This study evaluated whether a 16-week weight-loss program using tirzepatide before elective ventral and incisional hernia surgery could improve surgical readiness and outcomes in patients with obesity. In this retrospective multicenter study, 109 patients entered the program, and 91 completed treatment and underwent surgery. Participants achieved an average weight loss of 13.8%, and all patients who completed the program reached the target weight required for surgery. Compared with a control group of obese patients who underwent hernia repair without pharmacological prehabilitation, the tirze…

A Study of LY3457263 in Obese Participants

CompletedPhase 138 peopleRandomizedEli Lilly and Company2022-11-11 → 2023-06-08🇺🇸 United States

Studying: Overweight, Obesity · NCT05582096

About this trial

The main purpose of this study is to evaluate the safety and tolerability of LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 weeks.

Tirzepatide for Obesity and Meth Use Disorder

CompletedPhase 235 peopleUniversity of Texas Southwestern Medical Center2025-02-03 → 2026-02-12🇺🇸 United States

Studying: Obesity, Methamphetamine Use Disorder · NCT06745128

About this trial

This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.

Effect of Tirzepatide on Brown Adipose Tissue in Obesity

CompletedPhase 234 peopleRandomizedUniversity Medical Centre Ljubljana2025-03-18 → 2025-11-29🌐 Slovenia

Studying: Obesity · NCT06893211

About this trial

This study is testing whether a new anti-obesity medicine called tirzepatide can increase the activity of special fat cells in the body that help burn energy. These fat cells are known as brown and beige fat. The study includes women with obesity and will last 24 weeks. Participants will receive either tirzepatide or a placebo (a look-alike injection with no active drug). Researchers will measure the amount and activity of brown fat using medical imaging (PET/CT, MRI, and thermal camera), and examine fat tissue samples to look for changes in gene activity and structure that show beige fat act…

Role Of Metabolic Adaptation In Weight Regain

Completed27 peoplePennington Biomedical Research Center2022-10-06 → 2024-05-24🇺🇸 United States

Studying: Weight Loss, Weight Gain, Obesity · NCT05766358

About this trial

In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invite…

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

Completed25 peopleUniversity of Kansas Medical Center2024-09-14 → 2026-03-25🇺🇸 United States

Studying: Obesity, Breast Cancer Risk · NCT06485089

About this trial

Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.

Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

CompletedPhase 212 peopleUniversity of Hawaii2025-11-12 → 2026-06-02🇺🇸 United States

Studying: Obesity and Overweight, HIV, Chronic Inflammation · NCT06935838

About this trial

This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change…

Stopped early or withdrawn 4

A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

WithdrawnPhase 2RandomizedEli Lilly and Company2025-05-23 → 2025-06-10🇦🇷🇨🇦🇨🇳🇯🇵 Argentina, Canada, China, Japan +1 more

Studying: Obesity, Overweight · NCT06901349

About this trial

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over

TerminatedPhase 2204 peopleRandomizedBioAge Labs, Inc.2024-06-27 → 2025-02-06🇺🇸 United States

Studying: Obesity · NCT06515418

About this trial

This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 years and older. The researchers are also looking at safety. Estimated Study Length: * with the optional prescreening, the study duration may be up to 48 weeks. * the treatment duration will be 24 weeks followed by 12 weeks follow-up. * the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.

Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

WithdrawnPhase 4RandomizedWashington University School of Medicine2023-09-13 → 2024-05-29🇺🇸 United States

Studying: Obesity, Metabolic Disease · NCT06009653

About this trial

The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the inte…

The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study.

WithdrawnCorEvitas2023-07-01 → 2023-07-01

Studying: Metabolic Health · NCT06354101

About this trial

The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.

Status unknown 3

Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa

Unknown status20 peopleFlorida Academic Centers Research and Education, LLC2024-03-11 → 2025-03-11

Studying: Hidradenitis Suppurativa · NCT06301256

About this trial

The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks .

Tirzepatide Monotherapy in Patients With Wolfram Syndrome Type 1

Unknown statusPhase 210 peopleOspedale San Raffaele2024-01-01 → 2024-10🇮🇹 Italy

Studying: Wolfram Syndrome · NCT05659368

About this trial

Wolfram syndrome (WFS:OMIM 222300) is a group of inherited disorders that usually appear in childhood and cause diabetes, optic atrophy leading to loss of vision, deafness and often diabetes insipidus. Wolfram syndrome affected no more than 0.2 in 10,000 people in the European Union. There is no cure and no treatment that will arrest or delay the progress of the disease. The gene responsible for WS1 is WFS1, it encodes for wolframin, a transmembrane glycoprotein involved in the regulation of the unfolded protein response. Recently, drug repurposing has been hypothesized from others and us as …

Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Unknown status100 peopleRandomizedNanjing First Hospital, Nanjing Medical University2023-08-01 → 2024-01-01🇨🇳 China

Studying: Diabetes · NCT05990374

About this trial

The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

Registered trials include ones that haven't published results yet. Trials are matched on the compound's name and code names (Tirzepatide, LY3298176) in the listed interventions.