Lesson · 2 min read · Mazdutide
Mazdutide: what the studies show
Approval depends on the country
Mazdutide is also called IBI362 and LY3305677. China approved mazdutide injection in June 2025 for long-term weight management alongside diet and physical activity in eligible adults. The Chinese label uses BMI at least 28, or at least 24 with a weight-related condition.
No FDA-approved mazdutide product was identified as of November 6, 2026. Chinese approval does not establish a United States prescribing label. The US trial tested an investigational formulation.
What the trials found
GLORY-1 randomized 610 Chinese adults. At 48 weeks, weight changes were -11.00% and -14.01% with mazdutide versus +0.30% with placebo in the treatment-policy analysis. Its primary assessment occurred at 32 weeks.
A separate US phase 2 trial enrolled 179 adults without type 2 diabetes. It also found greater weight loss than placebo, using an efficacy analysis that assumed continued assigned treatment. Adverse events led one fifth of the highest-dose group to stop treatment.
Weekly subcutaneous treatment
Both trials used weekly subcutaneous injections. Their results do not establish efficacy for oral products or unverified preparations. Effects on cardiovascular events and how long people continue treatment remain unanswered by these studies.
Quick check
Does mazdutide approval in China establish an FDA-approved United States regimen?
Sources
- NMPA, June 30, 2025: Mazdutide injection approvals dated June 24, 2025
- Liaoning provincial drug regulator, August 6, 2026: Mazdutide approval for adult weight management
- Innovent: Chinese mazdutide prescribing information, approved June 24, 2025
- FDA, March 31, 2026: Prime Sciences warning letter identifies unapproved mazdutide products
- FDA Drugs@FDA: no application for mazdutide, searched November 6, 2026
- Ji et al., May 25, 2025: GLORY-1 in Chinese adults with obesity or overweight
- Hsia et al., August 21, 2026: US phase 2 randomized mazdutide trial
- FDA substance identity record: mazdutide, IBI-362, and LY-3305677, accessed November 6, 2026
Peptiday editorial summary, not clinically reviewed, November 6, 2026. For education only, not medical advice. Talk to a clinician before starting, stopping or changing treatment.