A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity
Ji L, Jiang H, Bi Y, et al. Lancet Diabetes Endocrinol. 2024 (published online Dec 12, 2023). NCT04904913. View source ↗
This randomized, double-blind, placebo-controlled phase 2 trial enrolled 248 Chinese adults with overweight (BMI ≥24 kg/m² with hyperphagia or at least one obesity-related comorbidity) or obesity (BMI ≥28 kg/m²) across 20 hospitals. Participants were randomized to once-weekly subcutaneous mazdutide 3 mg, 4.5 mg, 6 mg, or matching placebo for 24 weeks. Mean percentage change in body weight from baseline at week 24 was -6.7%, -10.4%, and -11.3% for the 3 mg, 4.5 mg, and 6 mg arms respectively, versus +1.0% for placebo. Secondary endpoints — including the proportion of participants achieving ≥5%, ≥10%, and ≥15% weight reduction, and improvements in waist circumference, blood pressure, lipid profile, and liver enzymes — favored mazdutide across the dose range. The adverse-event profile was predominantly gastrointestinal and dose-dependent, consistent with the incretin and glucagon agonist class.
Researchers ran a 24-week study in roughly 250 Chinese adults with overweight or obesity, comparing three doses of weekly mazdutide injections (3 mg, 4.5 mg, 6 mg) to placebo. Average weight loss climbed with dose — about 7%, 10%, and 11% at the three dose levels — while placebo participants gained a small amount of weight on average. Most side effects were stomach-related (nausea, decreased appetite, diarrhea), as is typical for this class of molecule.
