Mazdutide
Also called IBI362, IBI-362, LY3305677, LY-3305677.
Mazdutide is still investigational, with no FDA-approved product. This page cites 2 sources, and the strongest evidence comes from human trials.
- Status
- Investigational
- Form
- Injection
- Half-life
- Not modeled
- Strongest evidence
- Human trials
- Cited claims
- 2
- Last updated
- November 6, 2026
What the evidence says
Each claim names the kind of study behind it, what it can't tell you, and where it comes from.
Human trials
GLORY-1 randomized 610 Chinese adults with obesity or overweight and a weight-related condition. At 48 weeks, mean weight changes were -11.00% and -14.01% with mazdutide versus +0.30% with placebo under the treatment-policy analysis.
Limits: The trial used Chinese BMI eligibility thresholds and specific weekly subcutaneous formulations. Its 32-week primary endpoints and 48-week follow-up do not establish cardiovascular outcomes, and findings do not establish efficacy for every preparation or jurisdiction.
Human trials
A US phase 2 trial randomized 179 adults without type 2 diabetes. At 32 weeks, mazdutide groups had estimated weight reductions of 7.3% to 18.1%, versus 0.9% with placebo using the efficacy estimand.
Limits: This small dose-finding trial used an analysis assuming continued assigned treatment. Gastrointestinal events predominated, and adverse events led 20% of participants in the highest-dose group to stop treatment. Results do not establish FDA approval or long-term clinical outcomes.
Regulatory status
United States
No FDA-approved mazdutide product was identified as of November 6, 2026. FDA described marketed mazdutide products as unapproved in its March 2026 Prime Sciences warning letter. A published US phase 2 study and approval in China do not establish a United States prescribing label.
China
China approved mazdutide injection in June 2025 for long-term weight management with diet and physical activity in eligible adults with obesity or overweight and a weight-related condition. NMPA records date the initial approvals June 24. This is a jurisdiction-specific approval and does not establish United States approval.