Mazdutide 9 mg in Chinese adults with a body mass index ≥30 kg/m2 but without diabetes: A phase 2 randomized controlled trial

Clinical Snapshot

Key Findings

• P Value: p < 0.0001

• Effect Size: Treatment difference: -14.58%

• Primary Outcome: Mean percentage change in body weight: -12.78% (mazdutide) vs +1.80% (placebo)

• Nnt Or Sensitivity: NNT = 1.2 for achieving ≥5% weight loss (81.7% vs 0% response rate)

• Confidence Interval: 95% CI -18.00 to -11.16

Clinical Application

Once-weekly injection may improve adherence compared to daily medications, but GI tolerability concerns limit broader application Would require TGA approval for obesity indication. PBS listing would depend on cost-effectiveness analysis. RACGP obesity guidelines emphasise lifestyle interventions first-line Adults with obesity (BMI ≥30 kg/m²) without diabetes, particularly those of East Asian ethnicity

Abstract

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. CONCLUSIONS: 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. FUNDING: This study was sponsored by Innovent Biologics.

References

1. 1.Ji, L., Jiang, H., Cheng, Z., Li, X., Pang, S., Zhang, Y., Qiu, W., Ma, Q., Liu, Z., Wang, Y., Deng, H., Du, H., Han-Zhang, H., & Qian, L. (2026). Mazdutide 9 mg in Chinese adults with a body mass index ≥30 kg/m2 but without diabetes: A phase 2 randomized controlled trial. Med (New York, N.Y.). https://doi.org/10.1016/j.medj.2026.101063