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Dulaglutide research

What published studies found for Dulaglutide: 8 papers, 8 in humans, with sample sizes and key results, plus 95 registered clinical trials.

Strong human evidence

Why: Approved drug; many large RCTs (incl. the 9,901-person REWIND trial) consistently show better glucose control and fewer cardiovascular events.

Dulaglutide (a once-weekly GLP-1 receptor agonist for type 2 diabetes) is supported by many large human RCTs showing improved blood-sugar control and, in the REWIND outcomes trial, a modest reduction in cardiovascular events; its weight-loss effect is smaller than semaglutide or tirzepatide, and gastrointestinal side effects are common.

✓ 4 positive~ 2 mixed? 2 inconclusive

Severe GI complications such as pancreatitis or bowel obstruction were similar in frequency to semaglutide and tirzepatide in one large observational study.

US compounding: FDA-approved drug. FDA-approved (Trulicity). It's a biologic-sized fusion protein; compounded versions aren't a recognised option. Status for every peptide.

Browse and filter these papers Dulaglutide prices and vendors

Reported side effects

commonNausea [ref] [ref]
commonDiarrhea and vomiting [ref] [ref]
commonGastrointestinal adverse events overall [ref] [ref] [ref]
rareSevere hypoglycemia [ref]

Registered clinical trials

95 trials of Dulaglutide on ClinicalTrials.gov: 12 active, 72 completed, 39 with posted results. Registered trials include ones that haven't published yet.

Trial	Status	Phase	People	Sponsor
A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With MetforminNCT06257966 · started 2024-07-17	Active, not recruiting	Phase 3	600	Beijing Dongfang Biotech Co., Ltd.
A Phase 3 Study of HS-20094 in Patients With T2DMNCT07156539 · started 2025-09-30	Not yet recruiting	Phase 3	546	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney DiseaseNCT07537088 · started 2026-05	Not yet recruiting	Phase 4	468	First Affiliated Hospital of Wannan Medical College
GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac SurgeryNCT06324461 · started 2024-03-20	Recruiting	Phase 4	372	The University of Hong Kong
A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or MetforminNCT07109700 · started 2025-04-30	Recruiting	Phase 2	216	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 DiabetesNCT07668336 · started 2026-09	Not yet recruiting	Phase 3	170	Eli Lilly and Company
Role of GLP1 RA Dulaglutide on Severe Intracranial AtherosclerosisNCT07282041 · started 2025-12-17	Recruiting	Phase 2, Phase 3	130	National University of Singapore
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes MellitusNCT07677891 · started 2026-10	Not yet recruiting	Phase 2	60	ProGen. Co., Ltd.
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)NCT06739122 · started 2025-01-10	Recruiting	Phase 3	55	Eli Lilly and Company
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes MellitusNCT07319286 · started 2025-08-04	Enrolling by invitation	Phase 1, Phase 2	50	Ain Shams University
Therapeutic Strategies for Microvascular Dysfunction in Type 1 DiabetesNCT05478707 · started 2023-10-05	Recruiting	Phase 2	47	AdventHealth Translational Research Institute
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose IntoleranceNCT04731272 · started 2021-07-16	Recruiting	Phase 2	30	University of Pennsylvania

All 95 Dulaglutide trials, with countries and recruiting status

Human studies

~ Mixedhuman RCTN Engl J Med · 2025

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

n = 13,299 humansActive-comparator, double-blind noninferiority trial (SURPASS-CVOT)

In 13,165 patients with type 2 diabetes and atherosclerotic disease, major cardiovascular events occurred in 13.1% on dulaglutide vs 12.2% on tirzepatide (tirzepatide noninferior, not superior).

Key resultPrimary event in 801 (12.2%) tirzepatide vs 862 (13.1%) dulaglutide patients (HR 0.92; 95.3% CI 0.83 to 1.01; P = 0.003 noninferiority; P = 0.09 superiority).

Studied: Adults with type 2 diabetes and atherosclerotic cardiovascular disease
Compared with: Dulaglutide 1.5 mg weekly
Main outcome: Composite of cardiovascular death, myocardial infarction or stroke
Sample: 13,299 randomized; modified ITT 6586 tirzepatide and 6579 dulaglutide
Authors' conclusion: Tirzepatide was noninferior to dulaglutide for the composite of cardiovascular death, MI or stroke; more gastrointestinal adverse events occurred with tirzepatide.
Limitations: Superiority not shown.

PubMed 41406444 DOI

✓ Positivehuman RCTLancet · 2019

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

n = 9,901 humansMulticentre, double-blind, randomised placebo-controlled trial (REWIND), 371 sites in 24 countriesMedian follow-up 5.4 years

In 9901 people with type 2 diabetes followed 5.4 years, dulaglutide reduced major cardiovascular events (12.0% vs 13.4%; HR 0.88) but not all-cause mortality; GI adverse events 47.4% vs 34.1%.

Key resultPrimary outcome in 594 (12.0%) dulaglutide vs 663 (13.4%) placebo participants (HR 0.88, 95% CI 0.79-0.99; p=0.026). GI adverse events 47.4% vs 34.1% (p<0.0001).

Studied: Adults aged 50+ with type 2 diabetes and previous cardiovascular event or risk factors (mean age 66.2 years)
Compared with: Placebo
Main outcome: First non-fatal MI, non-fatal stroke, or cardiovascular death
Sample: 9901 randomized (dulaglutide 4949, placebo 4952)
Authors' conclusion: Dulaglutide could be considered for glycaemic management in middle-aged and older people with type 2 diabetes with previous cardiovascular disease or risk factors. All-cause mortality did not differ significantly.

PubMed 31189511 DOI

? Inconclusivehuman RCTLancet Neurol · 2020

Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.

n = 9,901 humansExploratory analysis of a randomised, double-blind, placebo-controlled trialMedian follow-up 5.4 years

Exploratory REWIND analysis: substantive cognitive impairment was not significantly reduced in the main analysis (HR 0.93) but was 14% lower after post-hoc adjustment.

Key resultCognitive outcome HR 0.93 (95% CI 0.85-1.02; p=0.11); after post-hoc adjustment for baseline scores HR 0.86 (0.79-0.95; p=0.0018).

Studied: REWIND participants aged 50+ with type 2 diabetes and cardiovascular risk factors
Compared with: Placebo
Main outcome: First substantive decline on MoCA or DSST (1.5 SD or more below baseline)
Sample: 9901 randomized; 8828 had cognitive scores
Authors' conclusion: Long-term dulaglutide might reduce cognitive impairment in type 2 diabetes; further studies focused on brain health are indicated.
Limitations: Exploratory analysis; primary cognitive outcome was not significant before post-hoc adjustment.

PubMed 32562683 DOI

~ Mixedhuman RCTLancet Diabetes Endocrinol · 2018

Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.

n = 1,201 humansOpen-label, parallel-group, phase 3b trial (SUSTAIN 7)40 weeks

In 1201 people with type 2 diabetes, dulaglutide lowered HbA1c by 1.1-1.4 points and weight by 2.3-3.0 kg at 40 weeks, both significantly less than semaglutide; GI disorders in 33-48%.

Key resultHbA1c fell 1.8 points with semaglutide 1.0 mg vs 1.4 with dulaglutide 1.5 mg (ETD -0.41; p<0.0001); bodyweight fell 6.5 kg vs 3.0 kg.

Studied: Adults with type 2 diabetes inadequately controlled on metformin monotherapy
Compared with: Dulaglutide 0.75 mg or 1.5 mg
Main outcome: Change in HbA1c and bodyweight at week 40
Sample: 1201 randomized to four arms
Authors' conclusion: At low and high doses, semaglutide was superior to dulaglutide for glycaemic control and weight reduction, with a similar safety profile.
Limitations: Open-label; sponsored by Novo Nordisk (maker of semaglutide).

PubMed 29397376 DOI

✓ Positivehuman RCTLancet Diabetes Endocrinol · 2018

Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial.

n = 577 humansMulticentre, open-label randomised trial (AWARD-7); dulaglutide doses masked52 weeks (primary outcome at 26 weeks)

In 577 people with type 2 diabetes and moderate-severe kidney disease, dulaglutide matched insulin glargine for HbA1c and showed slower eGFR decline and less hypoglycemia, but more nausea (up to 20%) and diarrhea (up to 17%).

Key resultAt 26 weeks LSM HbA1c change was -1.2% with dulaglutide 1.5 mg, -1.1% with 0.75 mg and -1.1% with insulin glargine; both doses were non-inferior. Symptomatic hypoglycaemia was lower with dulaglutide.

Studied: Adults with type 2 diabetes and stage 3-4 chronic kidney disease
Compared with: Daily insulin glargine, all with insulin lispro
Main outcome: HbA1c at 26 weeks (non-inferiority margin 0.4%)
Sample: 577 randomized (193, 190 and 194 per arm)
Authors' conclusion: Once-weekly dulaglutide gave glycaemic control similar to insulin glargine with reduced decline in eGFR, and seems safe in moderate-to-severe CKD.
Limitations: Open-label for insulin glargine comparison.

PubMed 29910024 DOI

✓ Positivehuman RCTLancet Diabetes Endocrinol · 2018

Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.

n = 424 humansPhase 3b double-blind, parallel-arm, placebo-controlled trial (AWARD-10)24 weeks

In 424 people on SGLT2 inhibitors, adding dulaglutide lowered HbA1c by 0.66-0.79 points more than placebo at 24 weeks; nausea up to 15% vs 4%.

Key resultHbA1c fell more with dulaglutide 1.5 mg than placebo: LSM difference -0.79% (95% CI -0.97 to -0.61; p<0.0001); 0.75 mg difference -0.66% (-0.84 to -0.49; p<0.0001).

Studied: Adults with type 2 diabetes inadequately controlled on an SGLT2 inhibitor with or without metformin
Compared with: Placebo
Main outcome: Change in HbA1c at 24 weeks
Sample: 424 randomized (142 dulaglutide 1.5 mg, 142 dulaglutide 0.75 mg, 140 placebo)
Authors' conclusion: Dulaglutide added to SGLT2 inhibitors gave significant, clinically relevant glycaemic improvement with acceptable tolerability, mainly more gastrointestinal adverse events.
Limitations: 24-week duration.

PubMed 29483060 DOI

✓ Positivehuman RCTN Engl J Med · 2022

Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes.

n = 154 humansDouble-blind, placebo-controlled trial (AWARD-PEDS) followed by open-label extension26 weeks (plus 26-week open-label extension)

In 154 youths with type 2 diabetes, dulaglutide lowered HbA1c by 0.6-0.9 points at 26 weeks while placebo rose 0.6, with no difference in BMI and more GI adverse events.

Key resultHbA1c rose 0.6 points with placebo and fell 0.6 (0.75 mg) and 0.9 (1.5 mg) points with dulaglutide (P<0.001 for both vs placebo); HbA1c <7.0% in 51% vs 14% (P<0.001).

Studied: Youths with type 2 diabetes, BMI above 85th percentile
Compared with: Placebo
Main outcome: Change from baseline in HbA1c at 26 weeks
Sample: 154 randomized participants aged 10 to <18 years
Authors' conclusion: Once-weekly dulaglutide 0.75 mg or 1.5 mg was superior to placebo for glycemic control through 26 weeks in youths with type 2 diabetes, without an effect on BMI.
Limitations: GI adverse events more frequent with dulaglutide.

PubMed 35658022 DOI

? Inconclusivehuman observationalAnn Intern Med · 2026

Comparative Gastrointestinal Safety of Dulaglutide, Semaglutide, and Tirzepatide in Adults With Type 2 Diabetes.

Matched pairs: 65 238 (semaglutide vs dulaglutide), 20 893 (tirzepatide vs dulaglutide), 46 620 (tirzepatide vs semaglutide)Population-based new-user, active-comparator cohort study with propensity score matching

In large matched real-world cohorts, risk of severe GI events (pancreatitis, biliary disease, bowel obstruction, gastroparesis, severe constipation) was similar for dulaglutide, semaglutide and tirzepatide.

Key resultHR for severe GI events was 0.96 (95% CI 0.87 to 1.06) semaglutide vs dulaglutide and 0.96 (0.77 to 1.20) tirzepatide vs dulaglutide.

Studied: Adults with type 2 diabetes starting dulaglutide, semaglutide or tirzepatide (2019-2024)
Compared with: Pairwise: dulaglutide, subcutaneous semaglutide, tirzepatide
Main outcome: Composite of acute pancreatitis, biliary disease, bowel obstruction, gastroparesis, severe constipation
Authors' conclusion: Dulaglutide, semaglutide and tirzepatide have similar gastrointestinal safety profiles in adults with type 2 diabetes.
Limitations: Possible residual confounding by glycemic control and BMI.

PubMed 41183330 DOI Free full text

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.