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

Diabetes Care. 2024 Jan 1;47(1):160-168. doi: 10.2337/dc23-1287.


Objective: We conducted a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the efficacy and safety of mazdutide, a once-weekly glucagon-like peptide 1 and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes.

Research design and methods: Adults with type 2 diabetes inadequately controlled with diet and exercise alone or with stable metformin (glycated hemoglobin A1c [HbA1c] 7.0-10.5% [53-91 mmol/mol]) were randomly assigned to receive 3 mg mazdutide (n = 51), 4.5 mg mazdutide (n = 49), 6 mg mazdutide (n = 49), 1.5 mg open-label dulaglutide (n = 50), or placebo (n = 51) subcutaneously for 20 weeks. The primary outcome was change in HbA1c from baseline to week 20.

Results: 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). Mean percent changes in body weight from baseline to week 20 were dose dependent and up to -7.1% with mazdutide (-2.7% with dulaglutide and -1.4% with placebo). At week 20, participants receiving mazdutide were more likely to achieve HbA1c targets of <7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol) and body weight loss from baseline of ≥5% and ≥10% compared with placebo-treated participants. The most common adverse events with mazdutide included diarrhea (36%), decreased appetite (29%), nausea (23%), vomiting (14%), and hypoglycemia (10% [8% with placebo]).

Conclusions: In Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reductions.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Body Weight
  • China
  • Diabetes Mellitus, Type 2* / chemically induced
  • Diabetes Mellitus, Type 2* / drug therapy
  • Double-Blind Method
  • Drug Therapy, Combination
  • Glucagon-Like Peptide 1 / therapeutic use
  • Glucagon-Like Peptides / adverse effects
  • Glycated Hemoglobin
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Treatment Outcome


  • mazdutide
  • Hypoglycemic Agents
  • Glycated Hemoglobin
  • Glucagon-Like Peptide 1
  • Glucagon-Like Peptides

Grants and funding

This study was sponsored by Innovent Biologics, Inc. B.Z., Z.C., X.Z., D.L., H.J., G.M., X.W., S.G., J.S., P.J., J.Y., B.S., J.M., S.Y., G.W., L.J., X.G., and W.Y. received research funding from Innovent Biologics, Inc., during the conduct of the study. The sponsor of the study was involved in the study design, data collection, data review, data analysis, data interpretation, and writing of the report.