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Most Mazdutide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2021–2026 with a typical study size of 250 participants.
Based on 13 studies · 2 meta-analyses · 10 RCTs · 3,482 total participants
Confidence
High
By outcome
Weight management
Mostly mechanism / observational12 studies
Safety profile
Mostly mechanism / observational11 studies
Glycemic & metabolic control
Mostly mechanism / observational8 studies
Heart & blood pressure
Too few graded studies2 studies
Liver fat & MASLD
Too few graded studies1 study
Active research area
13 studies in the last 5 years · Latest meta-analysis: 2026
20212026
1RCTn=461 · medium study2026
At week 60, the mean percentage change in body weight from baseline was -16.65%... in the mazdutide group compared with -1.50%... in the placebo group.
Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, et al. · JAMA (2026)
60-week phase-3 double-blind placebo-controlled RCT (GLORY-2) in 461 Chinese adults with obesity (BMI >=30), mazdutide 9 mg vs placebo
Mean weight change -16.65% vs -1.50% placebo (between-group difference -15.15%); 84.3% lost >=5% vs 33.1%
GI adverse events common at 9 mg: vomiting 53.1%, nausea 46.9%, diarrhea 39.4% (most mild-to-moderate)
At week 48, the mean percentage change in body weight from baseline was -11.00%... in the 4-mg mazdutide group, -14.01%... in the 6-mg mazdutide group, and 0.30%... in the placebo group.
Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, et al. · N Engl J Med (2025)
48-week phase-3 double-blind placebo-controlled RCT (GLORY-1) in 610 Chinese adults with overweight/obesity, mazdutide 4 mg or 6 mg vs placebo
At week 32, weight change -10.09% (4 mg) and -12.55% (6 mg) vs +0.45% placebo; 73.9%/82.0% lost >=5% vs 10.5%
At week 48, -11.00% / -14.01% vs +0.30%; 35.7%/49.5% lost >=15% vs 2.0%
At week 24, mazdutide significantly reduced HbA1c versus placebo: -1.57% with mazdutide 4 mg and -2.15% with mazdutide 6 mg, versus -0.14% with placebo.
Zhu D, Zhao J, Cai H, Chu X, Xiu S, Song C, Cheng Z, et al. · Nature (2026)
Phase-3 RCT in 320 Chinese adults with type 2 diabetes inadequately controlled on diet/exercise, mazdutide 4/6 mg vs placebo for 24 weeks
HbA1c -1.57% (4 mg) and -2.15% (6 mg) vs -0.14% placebo (treatment differences -1.43% and -2.02%)
Weight loss -5.61% (4 mg) and -7.81% (6 mg) vs -1.26% placebo
Both doses of mazdutide showed non-inferiority and superiority to the 1.5-mg dose of dulaglutide in terms of the mean change in... HbA1c... and significantly greater reductions in body weight.
Guo L, Zhang B, Xue X, Zhang X, Cai H, Jiang H, Zhang L, et al. · Nature (2026)
Phase-3 head-to-head RCT in 731 Chinese adults with type 2 diabetes on background oral agents, mazdutide 4/6 mg vs dulaglutide 1.5 mg for 28 weeks
HbA1c treatment difference vs dulaglutide -0.24% (4 mg) and -0.30% (6 mg) — non-inferior and superior
Greater weight loss vs dulaglutide: difference -3.78% (4 mg) and -5.76% (6 mg)
The mean percentage changes from baseline to week 24 in body weight were -6.7%... with mazdutide 3 mg, -10.4%... with 4.5 mg, -11.3%... with 6 mg and 1.0%... with placebo.
Ji L, Jiang H, Cheng Z, Qiu W, Liao L, Zhang Y, et al. · Nat Commun (2023)
24-week phase-2 double-blind placebo-controlled RCT in 248 Chinese overweight adults or adults with obesity, mazdutide 3/4.5/6 mg vs placebo
Dose-dependent weight loss -6.7% to -11.3% vs +1.0% placebo (all p<0.0001)
Most common adverse events diarrhea, nausea, upper respiratory tract infection; all doses well tolerated
Mean changes in HbA1c from baseline to week 20 ranged from -1.41% to -1.67% with mazdutide (-1.35% with dulaglutide and 0.03% with placebo; all P < 0.0001 vs. placebo).
Zhang B, Cheng Z, Chen J, Zhang X, Liu D, Jiang H, et al. · Diabetes Care (2024)
20-week phase-2 RCT in 250 Chinese adults with type 2 diabetes, mazdutide 3/4.5/6 mg vs open-label dulaglutide 1.5 mg vs placebo
HbA1c -1.41% to -1.67% with mazdutide vs +0.03% placebo; weight loss up to -7.1% vs -1.4% placebo
More participants reached HbA1c <7.0% and >=5%/>=10% weight loss vs placebo
The mean percent change from baseline to week 12 in body weight were -11.7%... for participants receiving mazdutide in the 9 mg cohort and -1.8%... for participants receiving placebo.
Ji L, Gao L, Jiang H, Yang J, Yu L, Wen J, et al. · EClinicalMedicine (2022)
Phase-1b multiple-ascending-dose RCT in 24 Chinese adults with overweight/obesity, high-dose mazdutide (9 mg, 10 mg cohorts) vs placebo
12-week weight change -11.7% (9 mg) vs -1.8% placebo (ETD -9.8%); 16-week -9.5% (10 mg) vs -3.3% placebo
No serious adverse events; all treatment-emergent events mild or moderate (URTI, diarrhea, decreased appetite, nausea)
Estimated percent changes in mean body weight from baseline to week 12 were -4.81%... -6.40%... and -6.05%... for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort... compared with 0.60%... for those receiving placebo.
Ji L, Jiang H, An P, Deng H, Liu M, Li L, et al. · EClinicalMedicine (2021)
First-in-Chinese phase-1b multiple-ascending-dose RCT in 36 adults with overweight/obesity, IBI362 3/4.5/6 mg vs placebo over 12 weeks
Dose weight loss -4.81% to -6.40% vs +0.60% placebo; no discontinuations for safety, no serious adverse events
GI events and decreased appetite most common, mostly mild; three participants had mild asymptomatic ECG cardiac findings
In June 2025, mazdutide received its first approval, in China, for use... in long-term body weight management in adults... Subsequently, in September 2025, mazdutide also received approval in China for use in glycaemic control in adults with T2D.
Shirley M. · Drugs (2025)
Regulatory/development review of mazdutide, a dual glucagon (GcgR) and GLP-1 receptor agonist co-developed by Innovent Biologics and Eli Lilly
First approval in China (June 2025) for long-term weight management; second China approval (September 2025) for type 2 diabetes
Not FDA- or EMA-approved; investigational outside China