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Mazdutide research

What published studies found for Mazdutide: 7 papers, 7 in humans, with sample sizes and key results, plus 44 registered clinical trials.

A
Strong human evidence
Why: Three phase 3 RCTs and several phase 2 RCTs (over 2,000 Chinese adults) consistently show weight and blood-sugar improvements.

Mazdutide (a GLP-1/glucagon dual agonist) has consistent results from several placebo- and active-controlled human RCTs, including three phase 3 trials, showing about 11-14% weight loss at 48 weeks in obesity and better blood-sugar control than dulaglutide in type 2 diabetes; nearly all trials were done in Chinese adults and run 48 weeks or less.

✓ 6 positive? 1 inconclusive

Trials are largely limited to Chinese populations and up to 48 weeks; long-term safety is not established.

US compounding: Not compoundable. Not an FDA-approved drug and not nominated for FDA's 503A bulks list, so US pharmacies can't legally compound it. Status for every peptide.

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Reported side effects

Registered clinical trials

44 trials of Mazdutide on ClinicalTrials.gov: 24 active, 19 completed, 1 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or OverweightNCT06143956 · started 2023-11-17RecruitingPhase 21,481Eli Lilly and Company
A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) InhibitorNCT07417306 · started 2026-03-27Not yet recruitingPhase 3912Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic NephropathyNCT07775846 · started 2026-09-01Not yet recruitingPhase 4820Huijie Zhang
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）NCT06884293 · started 2025-05-09Active, not recruitingPhase 3479Innovent Biologics (Suzhou) Co. Ltd.
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight ManagementNCT07517042 · started 2026-06-10Recruiting–420Shanghai Zhongshan Hospital
Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)NCT07083154 · started 2025-09-27RecruitingPhase 3420The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/ObesityNCT07469800 · started 2026-04-23RecruitingPhase 3336Innovent Biologics (Suzhou) Co. Ltd.
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2NCT06931028 · started 2025-06-12RecruitingPhase 3260Innovent Biologics (Suzhou) Co. Ltd.
Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe ObesityNCT07135141 · started 2025-09-30Not yet recruiting–256Beijing Friendship Hospital
Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled TrialNCT07767552 · started 2026-09-30Not yet recruiting–249Yanbing Li
A Study of HRS-4729 Injection in Participants With Type 2 DiabetesNCT07843862 · started 2026-10Not yet recruitingPhase 2240Fujian Shengdi Pharmaceutical Co., Ltd.
GLP-1 Therapy After Bariatric Surgery in Chinese Patients With ObesityNCT07633639 · started 2026-05-01Recruiting–200China-Japan Friendship Hospital

All 44 Mazdutide trials, with countries and recruiting status

Meta-analyses & systematic reviews

✓ Positivemeta-analysisFront Endocrinol (Lausanne) · 2024

Efficacy and safety of Mazdutide on weight loss among diabetic and non-diabetic patients: a systematic review and meta-analysis of randomized controlled trials.

n = 680 humansSystematic review and meta-analysis (random effects)

Pooling 7 RCTs (680 participants), mazdutide reduced body weight by 6.22% vs placebo and improved blood pressure and lipids, with more transient mild-moderate GI side effects.

Key resultMean difference in body weight -6.22% (95% CI -8.02% to -4.41%, I2 = 90.0%); systolic blood pressure MD -7.57 mmHg
Studied
Adults with and without diabetes in randomized trials of mazdutide vs placebo
Compared with
Placebo
Main outcome
Body weight reduction and cardiometabolic measures
Sample
7 RCTs, 680 participants
Authors' conclusion
Mazdutide appears effective in weight reduction in patients with and without diabetes, but with mild or moderate transient gastrointestinal side effects.
Limitations
High heterogeneity for body weight (I2 = 90.0%); small trials.
PubMed 38440786DOIFree full text
Figure 2: Forest plot of the overall effect of Mazdutide vs placebo on percentage of weight reduction.
Figure 2. From PMC10911117, CC BY (terms); resized.

Human studies

✓ Positivehuman RCTNature · 2026

Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.

n = 731 humansRandomized phase III trial28 weeks

In 731 Chinese adults with type 2 diabetes, 28 weeks of mazdutide lowered HbA1c (by 0.24-0.30 points more) and weight (by 3.8-5.8% more) than dulaglutide, with more GI adverse events.

Key resultTreatment difference vs dulaglutide in HbA1c -0.24% (P = 0.0032) for 4 mg and -0.30% (P = 0.0003) for 6 mg mazdutide; body weight difference -3.78% and -5.76% (both P < 0.0001)
Studied
Chinese adults with type 2 diabetes on background oral anti-diabetic drugs
Compared with
Dulaglutide 1.5 mg
Main outcome
Change in HbA1c from baseline to week 28
Sample
731 participants with T2D randomized 1:1:1
Authors' conclusion
In Chinese participants with T2D, mazdutide 4 mg and 6 mg gave reductions in HbA1c and body weight superior to dulaglutide 1.5 mg; GI adverse events were more frequent with mazdutide.
Limitations
Chinese population only; 28-week duration.
PubMed 41407860DOI
✓ Positivehuman RCTN Engl J Med · 2025

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.

n = 610 humansPhase 3 double-blind placebo-controlled trial (GLORY-1)48 weeks (primary endpoints at week 32)

In 610 Chinese adults with overweight/obesity (GLORY-1), mazdutide reduced weight by 11.0-14.0% at 48 weeks vs +0.3% with placebo; discontinuation due to adverse events was 0.5-1.5%.

Key resultAt week 32, weight change was -10.09% (4 mg) and -12.55% (6 mg) vs 0.45% with placebo; 73.9%, 82.0% and 10.5% had at least 5% reduction (P<0.001 for all)
Studied
Chinese adults 18 to 75 years with BMI of at least 28, or 24 to <28 plus a weight-related condition
Compared with
Placebo
Main outcome
Percent change in body weight and weight reduction of at least 5% at week 32
Sample
610 participants randomized 1:1:1
Authors' conclusion
In Chinese adults with overweight or obesity, once-weekly mazdutide 4 mg or 6 mg led to clinically relevant reductions in body weight; adverse events were mostly mild to moderate GI.
Limitations
Chinese population; funded by Innovent Biologics.
PubMed 40421736DOI
✓ Positivehuman RCTNature · 2026

Mazdutide versus placebo in Chinese adults with type 2 diabetes.

n = 320 humansPhase 3 randomized placebo-controlled trial24 weeks plus 24-week extended mazdutide treatment

In 320 Chinese adults with type 2 diabetes, mazdutide monotherapy lowered HbA1c by 1.43-2.02 points more than placebo at 24 weeks and reduced weight 5.6-7.8% vs 1.3%.

Key resultHbA1c fell -1.57% (4 mg) and -2.15% (6 mg) vs -0.14% with placebo (treatment differences -1.43% and -2.02%, both P < 0.0001)
Studied
Chinese adults with T2D inadequately controlled with diet and exercise alone
Compared with
Placebo
Main outcome
HbA1c change at week 24
Sample
320 participants randomized 1:1:1
Authors' conclusion
Mazdutide monotherapy provided clinically meaningful glycaemic control and weight reduction with a favourable safety profile in this population.
Limitations
Chinese population only.
PubMed 41407859DOI
✓ Positivehuman RCTNat Commun · 2023

A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity.

n = 248 humansInterim analysis of randomised double-blind placebo-controlled phase 2 trial24 weeks

In 248 Chinese adults with overweight/obesity, 24 weeks of mazdutide reduced weight by 6.7-11.3% vs +1.0% with placebo; diarrhea and nausea were most common.

Key resultWeight change -6.7% (3 mg), -10.4% (4.5 mg), -11.3% (6 mg) vs 1.0% with placebo (all p < 0.0001)
Studied
Chinese overweight adults or adults with obesity
Compared with
Placebo
Main outcome
Percent change in body weight to week 24
Sample
248 randomised (62 at 3 mg, 63 at 4.5 mg, 61 at 6 mg, 62 placebo)
Authors' conclusion
In Chinese overweight adults or adults with obesity, 24-week mazdutide up to 6 mg was safe and led to robust, clinically meaningful weight reduction.
Limitations
Interim analysis of low-dose part only; Chinese population.
PubMed 38092790DOIFree full text
Fig. 2: Body weight efficacy endpoints.a Percentage change from baseline in body weight at week 24. Symbols and error bars represent LSM and SE, fro
Fig. 2. From PMC10719339, CC BY (terms); resized.
✓ Positivehuman RCTDiabetes Care · 2024

Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.

Arms of 51, 49, 49, 50 and 51 participants (about 250 total)Randomized double-blind placebo-controlled phase 2 trial20 weeks

In 250 Chinese adults with type 2 diabetes, 20 weeks of mazdutide lowered HbA1c by 1.41-1.67% (vs 0.03% placebo) and weight by up to 7.1%; diarrhea 36%, nausea 23%, vomiting 14%.

Key resultHbA1c changes -1.41% to -1.67% with mazdutide vs -1.35% with dulaglutide and 0.03% with placebo (all P < 0.0001 vs placebo)
Studied
Chinese adults with type 2 diabetes (HbA1c 7.0-10.5%) on diet and exercise or stable metformin
Compared with
Placebo and open-label dulaglutide 1.5 mg
Main outcome
Change in HbA1c from baseline to week 20
Authors' conclusion
In Chinese patients with type 2 diabetes, mazdutide up to 6 mg was generally safe and gave clinically meaningful HbA1c and body weight reductions.
Limitations
Chinese population; dulaglutide arm open-label.
PubMed 37943529DOIFree full text
? Inconclusivehuman trialEClinicalMedicine · 2022

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial.

n = 24 humansRandomised placebo-controlled multiple-ascending-dose phase 1b trial12 weeks (9 mg cohort) and 16 weeks (10 mg cohort)

In 24 Chinese adults with overweight/obesity, 12-16 weeks of high-dose mazdutide reduced weight by 9.5-11.7% vs 1.8-3.3% with placebo; adverse events were mild-moderate (too small to judge safety).

Key resultWeek 12 weight change -11.7% (SE 1.5) with mazdutide 9 mg vs -1.8% (1.6) with placebo (ETD -9.8%; 95% CI -14.4, -5.3; P = 0.0002)
Studied
Chinese adults with overweight (with hyperphagia or comorbidity) or obesity
Compared with
Placebo
Main outcome
Safety and tolerability; change in body weight, waist circumference and BMI
Sample
24 participants enrolled (8 mazdutide and 4 placebo per cohort)
Authors' conclusion
Mazdutide up to 9 mg and 10 mg was well tolerated with a favourable safety profile and promising 12-week weight loss; a larger, longer phase 2 trial is planned.
Limitations
Small phase 1b trial with 24 participants.
PubMed 36247927DOIFree full text
Figure 2: Change from baseline in body weight and waist circumference.a. Percent change from baseline in bodyweight over time. b. Change from baseline
Figure 2. From PMC9561728, CC BY (terms); resized.

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.