Study summary · research use only
Mazdutide 9 mg in Chinese adults with a body mass index ≥30 kg/m(2) but without diabetes: A phase 2 randomized controlled trial
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
In this randomized, double-blind, placebo-controlled phase 2 trial (NCT01904913) in Chinese adults with a body mass index ≥30 kg/m2 and without diabetes, eighty participants were randomized 3:1 to mazdutide 9 mg (n = 60) or placebo (n = 20) for 24 weeks, with percentage weight change from baseline to week 24 as the primary endpoint. The abstract reports mean percentage weight change of -12.78% with mazdutide 9 mg versus 1.80% with placebo (difference -14.58%, 95% CI -18.00 to -11.16, p < 0.0001), and that 81.7% of mazdutide participants reached ≥5% weight reduction versus none on placebo. Mazdutide was linked to greater improvement in cardiometabolic risk factors, and the most common adverse events were nausea (50.0% vs 0%), diarrhea (38.3% vs 10.0%), and vomiting (36.7% vs 10.0%), mostly mild to moderate.
Abstract
Once-weekly dual glucagon and glucagon-like peptide-1 receptor agonist mazdutide, administered at 4 and 6 mg, provides substantial weight loss in Chinese adults with overweight or obesity. This trial aimed to evaluate the efficacy and safety of mazdutide 9 mg in Chinese adults with obesity. In this randomized, double-blind, placebo-controlled phase 2 trial (NCT01904913), participants with a body mass index (BMI) ≥30 kg/m2 and without diabetes were randomized 3:1 to receive mazdutide 9 mg or placebo for 24 weeks. The primary endpoint was the percentage change in body weight from baseline to week 24. Eighty participants were randomized and received mazdutide 9 mg (n = 60) or placebo (n = 20). At week 24, the mean percentage change in weight from baseline was -12.78% with mazdutide 9 mg and 1.80% with placebo (treatment difference: -14.58% [95% confidence interval (CI) -18.00, -11.16], p < 0.0001). Weight reduction ≥5% was achieved by 81.7% of participants with mazdutide after 24-week treatment, while no participants with placebo achieved this threshold. Mazdutide treatment was associated with greater improvements in cardiometabolic risk factors vs. placebo. The most common adverse events included nausea (50.0% with mazdutide vs. 0% with placebo), diarrhea (38.3% vs. 10.0%), and vomiting (36.7% vs. 10.0%), predominantly mild to moderate in severity. Mazdutide 9 mg was safe and led to substantial weight reductions in Chinese adults with a BMI ≥ 30kg/m2 but without diabetes after 24-week treatment. These results support further clinical development of mazdutide 9 mg for the treatment of obesity. This study was sponsored by Innovent Biologics.
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