Introduction & Objective: To evaluate the efficacy and safety of mazdutide, a once-weekly GLP-1 and glucagon receptor dual agonist, in Chinese participants with overweight or obesity.
Methods: In this phase 3 randomized, double-blind, placebo-controlled trial (NCT05607680), we assigned 610 Chinese adults with a BMI of 28 kg/m2 or more, or 24 kg/m2 or more and at least one weight-related comorbidity, in a 1:1:1 ratio to receive once-weekly, subcutaneous mazdutide 4 mg, 6 mg or placebo for 48 weeks. Co-primary endpoints were the percentage change in weight from baseline and a weight reduction of 5% or more at week 32.
Results: At baseline, the mean body weight was 87.2 kg, the mean BMI was 31.1 kg/m2, and 83.1% of participants had a BMI of 28 kg/m2 or more. Mazdutide met co-primary endpoints and all key secondary endpoints, demonstrating superiority to placebo on body weight changes, weight-loss targets, and improvements on multiple cardiometabolic risk factors (Table). Mazdutide was well tolerated, with adverse events leading to treatment discontinuation reported in 1.5% of participants with mazdutide 4 mg, 0.5% with mazdutide 6 mg and 1.0% with placebo. The most frequently reported adverse events were gastrointestinal, mostly mild to moderate in severity.
Conclusion: In Chinese adults with overweight or obesity, mazdutide provides significant reductions in body weight and cardiometabolic risk factors.
L. Ji: None. H. Jiang: None. H. Li: None. J. Tian: None. D. Liu: None. Y. Zhao: None. J. Gu: None. Z. Liu: Employee; Innovent Biologics. H. Deng: Employee; Innovent. Y. Wang: Employee; Innoventbio. L. Li: Employee; innovent biologics. Stock/Shareholder; innovent biologics. L. Qian: Employee; Innoventbio.