Mazdutide
Mazdutide (IBI362)
Evidence & Status
- Strong Human Evidence
- Strong
At a Glance
A modified 34-amino-acid dual GLP-1/glucagon receptor agonist with China-specific approvals and direct Phase 3 evidence.
Plain English
Mazdutide is not FDA-approved in the United States; the listed approvals are China-specific.
Overview
A modified 34-amino-acid dual GLP-1/glucagon receptor agonist. China-specific NMPA approvals cover chronic weight management in specified adults with overweight or obesity and glycemic control in adults with type 2 diabetes.
Research Summary
Direct Phase 3 evidence includes Chinese adult obesity/overweight and type 2 diabetes studies. Trial exposures and administration are study-specific and are not universal dosing recommendations.
Research Areas
- Type 2 diabetes
- Obesity and weight management
- Non-alcoholic fatty liver disease (NAFLD/NASH)
- Metabolic syndrome
- Dual incretin pharmacology
Safety & Risks
Serious Risks
- Potential thyroid C-cell effects (GLP-1 class risk; not confirmed in humans)
- Pancreatitis (GLP-1 class risk)
- Not available outside clinical trials
- Safety profile still under evaluation
Reported Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Decreased appetite
- Injection site reactions
Legal Status by Region
- United States
- Not FDA-approved in the United States. China-specific NMPA approvals: chronic weight management in specified adults with overweight or obesity (June 2025), and glycemic control in adults with type 2 diabetes (September 2025).
- United Kingdom
- Investigational only
- Australia
- Investigational only
- Canada
- Investigational only
Citations & Sources
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight
PMID 40421736 · DOI 10.1056/NEJMoa2411528
- A Study of IBI362 in Participants With Obesity or Overweight
Registry NCT05607680
- Mazdutide versus placebo in Chinese adults with type 2 diabetes
PMID 41407859 · DOI 10.1038/s41586-025-10026-w
- A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Registry NCT05628311
- Mazdutide: First Approval
PMID 41028652 · DOI 10.1007/s40265-025-02249-y