Key papers ✓ 6? 1

• ✓ Positive human RCTN Engl J Med · 2025

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

  Humans610 peopleRandomizedPlacebo-controlledDouble-blind48 weeks (primary endpoints at week 32)

  Phase 3 double-blind placebo-controlled trial (GLORY-1)

  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)

  Study details

  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.

  DOI 10.1056/NEJMoa2411528PubMed 40421736
• ✓ Positive human RCTNature · 2026

  Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.

  Humans731 peopleRandomized28 weeks

  Randomized phase III trial

  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)

  Study details

  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.

  DOI 10.1038/s41586-025-10031-zPubMed 41407860
• ✓ Positive human RCTNature · 2026

  Mazdutide versus placebo in Chinese adults with type 2 diabetes.

  Humans320 peopleRandomizedPlacebo-controlled24 weeks plus 24-week extended mazdutide treatment

  Phase 3 randomized placebo-controlled trial

  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)

  Study details

  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.

  DOI 10.1038/s41586-025-10026-wPubMed 41407859
• ✓ Positive meta-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.

  Humans680 people7 RCTs pooled

  Systematic 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

  Study details

  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.

  DOI 10.3389/fendo.2024.1309118PubMed 38440786Free full text
  Figure 2
• ✓ Positive human RCTNat Commun · 2023

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

  Humans248 peopleRandomizedPlacebo-controlledDouble-blind24 weeks

  Interim analysis of randomised double-blind placebo-controlled phase 2 trial

  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)

  Study details

  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.

  DOI 10.1038/s41467-023-44067-4PubMed 38092790Free full text
  Fig. 2
• ✓ Positive human RCTDiabetes Care · 2024

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

  Humanssize not reportedRandomizedPlacebo-controlledDouble-blind20 weeks

  Randomized double-blind placebo-controlled phase 2 trial

  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)

  Study details

  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

  Sample

  Arms of 51, 49, 49, 50 and 51 participants (about 250 total)

  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.

  DOI 10.2337/dc23-1287PubMed 37943529Free full text
• ? Inconclusive human 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.

  Humans24 peopleRandomizedPlacebo-controlled12 weeks (9 mg cohort) and 16 weeks (10 mg cohort)

  Randomised placebo-controlled multiple-ascending-dose phase 1b trial

  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)

  Study details

  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.

  DOI 10.1016/j.eclinm.2022.101691PubMed 36247927Free full text
  Figure 2

Reported side effects

• commonDiarrhea [ref] [ref] [ref] [ref]
• commonNausea and vomiting [ref] [ref] [ref]
• commonDecreased appetite [ref] [ref]
• commonHypoglycemia (in type 2 diabetes; similar to placebo) [ref]
• reportedUpper respiratory tract infection [ref]

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

44 registered human trials (24 active)

✓ positive · ✗ negative · ~ mixed · ? inconclusive, judged on each paper's own main outcome. Grades: A strong human evidence → D little or none. Papers and verdicts are drawn from PubMed, Europe PMC and Russian journals (CyberLeninka); not medical advice.