Mazdutide research: studies, doses and safety
A weekly dual-hormone injection approved in China, with phase 3 weight-loss results.
Also called: IBI362, IBI-362, LY3305677, LY-3305677, Xinermei.
GLP-1 / glucagon dual agonists · GLP-1 and glucagon receptor dual agonist · Evidence: Approved drug.
China-approved. 45 distinct registered human protocols plus one case report found. Planned studies are included; a master-protocol duplicate and nonspecific registry are excluded.
Key studies
- First doses (ADA 2021): A small single-dose study supported weekly development. (source)
- Early repeat dosing: Conference-only results leave important dose and safety details missing. (source)
- Early diabetes dosing: Conference-only results leave important dose and safety details missing. (source)
- Early obesity trial: Weight or glucose improved; stomach symptoms limited tolerability. (source)
- Early diabetes trial: Weight or glucose improved; stomach symptoms limited tolerability. (source)
- Early 9 mg cohort: Weight or glucose improved; stomach symptoms limited tolerability. (source)
Related to Mazdutide
- Survodutide: A weekly dual-hormone injection with phase 3 weight-loss data and frequent stomach side effects.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
Sources
- 21 CFR 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act., Office of the Federal Register · eCFR · 2026
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, FDA · FDA · 2026
- Find product information about medicines, Medicines and Healthcare products Regulatory Agency · MHRA · 2026
- Medicines, European Medicines Agency · European Medicines Agency · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
- Understanding your responsibilities when importing, compounding and supplying unapproved peptide products, Therapeutic Goods Administration · Therapeutic Goods Administration · 2026
- WEGOVY- semaglutide injection, solution WEGOVY- semaglutide tablet, DailyMed · DailyMed · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2025
- Nutritional priorities to support GLP-1 therapy for obesity: a joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society., Mozaffarian D et al. · The American journal of clinical nutrition · 2025
- Weight loss medicine Mazdutide approved for commercialization in China, Shanghai Municipal Government · Shanghai Municipal Government · 2025
- Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration · TGA
Sources checked: 2026-10-18.
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