Mazdutide
IBI362
Mazdutide is a dual GLP-1/glucagon receptor agonist approved in China for weight management and T2D; currently in Phase 2 US trials. Not FDA-approved.
Overview
Mazdutide (IBI362) is a synthetic peptide developed by Innovent Biologics (under license from Eli Lilly) that acts as a dual agonist at both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor. This dual mechanism is designed to combine the appetite-suppressing and glucose-regulating effects of GLP-1 agonism with the energy expenditure and lipid metabolism effects associated with glucagon receptor activation.
Mazdutide is administered as a once-weekly subcutaneous injection and has been studied primarily in Chinese populations through the GLORY clinical trial program. In June 2025, mazdutide received approval in China (as Xinermei) for chronic weight management in adults with overweight or obesity, followed by approval for type 2 diabetes in September 2025, making it the world's first approved dual GLP-1/glucagon receptor agonist. It is not FDA-approved in the United States.
Research context
The GLORY Phase 3 program evaluated mazdutide in Chinese adults with obesity or overweight. Published results in the New England Journal of Medicine reported weight reductions in the range of 10–14% over 48 weeks across dose groups, with a high proportion of participants achieving clinically meaningful weight loss thresholds. Phase 2 and 3 data have also demonstrated improvements in glycemic parameters in adults with type 2 diabetes.
In the United States, mazdutide is currently in Phase 2 clinical trials, with Phase 3 studies and a potential NDA submission anticipated in the 2026–2028 timeframe. The DREAMS program is investigating head-to-head comparisons with semaglutide. Mazdutide's development in Asian populations fills an important evidence gap, as most incretin therapy data have historically been generated in predominantly Western populations.
Safety and regulatory framing
Approved in China (2025) for obesity and T2D; Phase 2 ongoing in the US
Mazdutide is approved in China for chronic weight management and type 2 diabetes. It is not FDA-approved in the United States and is currently in Phase 2 clinical development for US populations. The safety profile observed in Chinese clinical trials has been generally consistent with other incretin-class therapies, with gastrointestinal events being the most commonly reported adverse effects.
As an investigational drug in most countries outside China, mazdutide is not available through pharmacies or compounding services. Regulations and approval status vary by country. Readers should consult a licensed healthcare provider for any decisions related to investigational therapies.
References
- Ji L, et al. "Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight." NEJM (2024) ↗New England Journal of Medicine
- Phase 2 Randomized Controlled Trial of Mazdutide in Chinese Adults ↗Nature Communications (2023)
- ClinicalTrials.gov: Mazdutide Phase 2 in US Populations (NCT06143956) ↗ClinicalTrials.gov
- Innovent Biologics Mazdutide Press Releases ↗Innovent Biologics
Research information only
Peptide Daily is an informational resource only. Peptide research chemicals are not approved for human use by the FDA unless otherwise noted. Nothing on this site constitutes medical advice. Consult a qualified healthcare provider before using any peptide or research chemical.
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