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Mazdutide
GLP-1 Analogs

Mazdutide

Innovent Biologics (China) / Eli Lilly

Mazdutide (IBI362 / LY3305677) is a once-weekly subcutaneous peptide that activates both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). It carries both an Eli Lilly code (LY3305677) and an Innovent Biologics code (IBI362): Innovent ran the Chinese trials, and Lilly funded a US phase 2 trial. Regulatory status: mazdutide (Xinermei) received its first approval in China in June 2025, for long-term weight management in adults with a BMI of 28 kg/m² or more, or 24 kg/m² or more with a weight-related condition, and a second approval in China in September 2025 for glycaemic control in adults with type 2 diabetes. It has no FDA approval (no Drugs@FDA record), so in the US it is an investigational drug available only in clinical trials. Evidence: in the phase 3 GLORY-1 trial in 610 Chinese adults, mean weight change at 48 weeks was -11.0% with 4 mg and -14.0% with 6 mg versus +0.3% with placebo. GLORY-2 tested 9 mg in adults with a BMI of 30 or more and reported -16.7% versus -1.5% at 60 weeks. In type 2 diabetes, the phase 3 DREAMS trials showed HbA1c reductions of 1.57–2.15 percentage points versus placebo-treated participants' 0.14, and superiority over dulaglutide 1.5 mg. A US phase 2 trial tested doses up to 16 mg. Gastrointestinal effects (nausea, vomiting, diarrhea) were the most common adverse events and were more frequent at higher doses. Mazdutide belongs to the group of multi-receptor incretin drugs along with tirzepatide (GLP-1/GIP), survodutide (GLP-1/glucagon) and retatrutide (GLP-1/GIP/glucagon). Outside China, approved options such as semaglutide and tirzepatide are the standard of care.

Specifications

Origin / ManufacturerSynthetic peptide (GLP-1/glucagon receptor dual agonist)
Regulatory Status
NMPA-approved (China, 2025)
Active Components
Mazdutide
StoragePer approved product labeling (not covered by the sources on this page)
Shelf LifePer approved product labeling
Form FactorSubcutaneous injection, once weekly

Clinical Evidence

Phase 1b (type 2 diabetes, n=43, 12 weeks): IBI362 3–6 mg weekly lowered HbA1c and glucose; the most common adverse events were diarrhoea, decreased appetite and nausea.

Clinical report reference

Phase 2 (Chinese adults with overweight or obesity, n=248, 24 weeks): -6.7%, -10.4% and -11.3% with 3, 4.5 and 6 mg versus +1.0% with placebo.

Clinical report reference

Phase 2 (Chinese adults with type 2 diabetes, 20 weeks): HbA1c -1.41% to -1.67% versus -1.35% with dulaglutide and +0.03% with placebo; weight loss up to 7.1%.

Clinical report reference

GLORY-1 (phase 3, n=610, 48 weeks): -11.0% (4 mg) and -14.0% (6 mg) versus +0.3% with placebo; discontinuation for adverse events 0.5–1.5%.

Clinical report reference

GLORY-2 (phase 3, n=461, BMI ≥30, 9 mg, 60 weeks): -16.65% versus -1.50% with placebo; vomiting 53%, nausea 47% and diarrhoea 39% on mazdutide, mostly mild to moderate.

Clinical report reference

DREAMS-1 (phase 3, type 2 diabetes, n=320, 24 weeks): HbA1c -1.57% (4 mg) and -2.15% (6 mg) versus -0.14% with placebo.

Clinical report reference

DREAMS-2 (phase 3, type 2 diabetes, n=731, 28 weeks): both doses were superior to dulaglutide 1.5 mg on HbA1c and body weight.

Clinical report reference

US phase 2 (n=179, without diabetes, 32 weeks): -7.3% (3–6 mg), -15.6% (10 mg) and -18.1% (16 mg) versus -0.9% with placebo; 20% stopped the 16 mg dose because of adverse events.

Clinical report reference

Approved by China's NMPA for chronic weight management (June 2025) and type 2 diabetes (September 2025); not FDA-approved.

Clinical report reference

Frequently Asked Questions

Sources & References

Every clinical claim on this page traces to a primary peer-reviewed source.

  1. 1Jiang H, Pang S, Zhang Y, et al.. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nature Communications. 2022;13(1):3613. doi:10.1038/s41467-022-31328-x PMID:35750681
  2. 2Ji L, Jiang H, Cheng Z, et al.. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nature Communications. 2023;14(1):8289. doi:10.1038/s41467-023-44067-4 PMID:38092790
  3. 3Zhang B, Cheng Z, Chen J, et al.. Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Diabetes Care. 2024;47(1):160-168. doi:10.2337/dc23-1287 PMID:37943529
  4. 4Ji L, Jiang H, Bi Y, et al.. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. New England Journal of Medicine. 2025;392(22):2215-2225. doi:10.1056/NEJMoa2411528 PMID:40421736
  5. 5Gao L, Jiang H, Cai H, et al.. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026;336(5):377-388. doi:10.1001/jama.2026.8142 PMID:42251595
  6. 6Zhu D, Zhao J, Cai H, et al.. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature. 2026;652(8108):174-180. doi:10.1038/s41586-025-10026-w PMID:41407859
  7. 7Guo L, Zhang B, Xue X, et al.. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026;652(8108):181-188. doi:10.1038/s41586-025-10031-z PMID:41407860
  8. 8Hsia SH, Bays HE, Billings LK, et al.. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet Diabetes & Endocrinology. 2026;14(11):879-893. doi:10.1016/S2213-8587(26)00160-9 PMID:42628555
  9. 9Gan L, Duan L, Zheng X. Mazdutide Ameliorates Metabolic Dysfunction-Associated Steatotic Liver Disease by Modulating Endoplasmic Reticulum Stress, Improving Lipid Metabolism and Alleviating Inflammation. Pharmaceuticals (Basel). 2026;19(3). doi:10.3390/ph19030371 PMID:41901218
  10. 10Shirley M. Mazdutide: First Approval.. Drugs. 2025;85(12):1621-1627. doi:10.1007/s40265-025-02249-y PMID:41028652

Reviewed by

Clinical Research Review Board

Metabolic & Endocrine Peptide Review

All clinical claims cross-checked against primary sources. Read our editorial policy →

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