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Studien
Maz5.0
Mazdutide – Forschung
Überwiegend Mechanismus / Beobachtung
13 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Mazdutide sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2021–2026 mit einer typischen Studiengröße von 250 Teilnehmenden.
Basierend auf 13 Studien · 2 Meta-Analysen · 10 RCTs · 3,482 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Weight managementPhase-3-Studien zeigten ~11-14% Gewichtsverlust nach 48 Wochen und ~16,7% nach 60 Wochen (9 mg) gegenüber Placebo bei chinesischen Erwachsenen · Monate (mit Dosissteigerung)
Überwiegend Mechanismus / Beobachtung12 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung11 Studien
Glycemic & metabolic controlSenkte den HbA1c um bis zu ~2,2% gegenüber Placebo (Phase-3-Monotherapie); im direkten Vergleich Dulaglutide überlegen · Wochen bis Monate
Überwiegend Mechanismus / Beobachtung8 Studien
Heart & blood pressure
Zu wenige bewertete Studien2 Studien
Liver fat & MASLD
Zu wenige bewertete Studien1 Studie
Aktives Forschungsgebiet
13 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 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