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

This phase 2 clinical trial evaluated the efficacy and safety of mazdutide (IBI362), a dual GLP-1 and glucagon receptor agonist, in Chinese adults with overweight or obesity. The randomized, double-blind, placebo-controlled study included 248 participants with BMI ≥28 (or ≥24 with at least one metabolic comorbidity) and without diabetes.

Participants were randomized to receive weekly subcutaneous doses of mazdutide (3 mg, 4.5 mg, or 6 mg) or placebo for 24 weeks, with gradual dose escalation. The results demonstrated significant dose-dependent weight reduction:

• Mazdutide 3 mg: -7.2% weight loss
• Mazdutide 4.5 mg: -9.4% weight loss
• Mazdutide 6 mg: -11.7% weight loss
• Placebo: -1.0% weight loss

Beyond weight loss, mazdutide improved metabolic parameters including waist circumference, blood pressure, triglycerides, and LDL cholesterol. The dual GLP-1/glucagon mechanism is particularly interesting: while the GLP-1 component reduces appetite and delays gastric emptying, the glucagon component increases energy expenditure and promotes hepatic lipolysis.

The most common adverse events were gastrointestinal (nausea, diarrhea, vomiting), consistent with the GLP-1 agonist class, and were predominantly mild to moderate. Mazdutide, developed by Innovent Biologics, positions itself as a promising candidate in the obesity treatment market, especially in the Asian population.