Skip to content
Peptigraph home

Mazdutide: Trials and FDA Status

Mazdutide is a glp-1/glucagon dual agonist. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledIBI362
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Approved in China; investigational in the US
Phase
Phase 3
Sponsor
Innovent Biologics; Eli Lilly
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT04904913, NCT05607680, NCT05606913, NCT05628311, NCT06124807
Results

Reported results

  • 2025GLORY-1 phase 3 (NEJM 2025): weight change at 48 weeks vs placebo“At week 48, the mean percentage change in body weight from baseline was -11.00% (95% CI, -12.27 to -9.73) in the 4-mg mazdutide group, -14.01% (95% CI, -15.36 to -12.66) in the 6-mg mazdutide group, and 0.30% (95% CI, -0.98 to 1.58) in the placebo group”pubmed.ncbi.nlm.nih.gov

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

  1. FDA warning letters to five research-peptide sellersEnforcement
  2. Published in Nature (2026): Mazdutide versus placebo in Chinese adults with type 2 diabetes.
  3. Published in Nature (2026): Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.
  4. Published in The lancet. Diabetes & endocrinology (2026): Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial.
  5. Innovent announces China's NMPA approved mazdutide for chronic weight management in adults with overweight or obesity
  6. NCT06124807 (A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): primary completion
  7. Published in The New England journal of medicine (2025): Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.
  8. Innovent announces NMPA (China) acceptance of the second mazdutide NDA, for type 2 diabetes
  9. Innovent announces NMPA (China) acceptance of the first mazdutide NDA, for chronic weight management
  10. NCT05606913 (A Study of IBI362 in Participants With Type 2 Diabetes; Phase 3): primary completion
  11. Published in Diabetes care (2024): Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.
  12. NCT06124807 (A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): study start
  13. NCT06124807 (A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): first posted on ClinicalTrials.gov
  14. NCT05628311 (A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise; Phase 3): primary completion
  15. NCT05607680 (A Study of IBI362 in Participants With Obesity or Overweight; Phase 3): primary completion
  16. NCT04904913 (A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects; Phase 2): primary completion
  17. NCT05606913 (A Study of IBI362 in Participants With Type 2 Diabetes; Phase 3): study start
  18. NCT05628311 (A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise; Phase 3): study start
  19. NCT05628311 (A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise; Phase 3): first posted on ClinicalTrials.gov
  20. NCT05607680 (A Study of IBI362 in Participants With Obesity or Overweight; Phase 3): study start
  21. NCT05607680 (A Study of IBI362 in Participants With Obesity or Overweight; Phase 3): first posted on ClinicalTrials.gov
  22. NCT05606913 (A Study of IBI362 in Participants With Type 2 Diabetes; Phase 3): first posted on ClinicalTrials.gov
  23. NCT04904913 (A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects; Phase 2): study start
  24. NCT04904913 (A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects; Phase 2): first posted on ClinicalTrials.gov
  25. Published in EClinicalMedicine (2021): IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study.

What people search

  • mazdutide release date10/mo
  • mazdutide phase 310/mo
  • mazdutide fda approval10/mo
  • mazdutide fda10/mo

US monthly searches, Google Keyword Planner, Oct 2026. Shown so you can see which questions this page answers.

Sources

  1. 1A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects (NCT04904913)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  2. 2A Study of IBI362 in Participants With Obesity or Overweight (NCT05607680)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  3. 3A Study of IBI362 in Participants With Type 2 Diabetes (NCT05606913)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  4. 4A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise (NCT05628311)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  5. 5A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight (NCT06124807)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  6. 6FDA warning letters to five research-peptide sellersFDA warning letter (NuScience Peptides; 1 of 5) · 2026fda.govAccessed 2 Oct 2026
  7. 7IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study.EClinicalMedicine · 2021PMID 34430840Accessed 2 Oct 2026
  8. 8Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.Diabetes care · 2024PMID 37943529Accessed 2 Oct 2026
  9. 9Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.The New England journal of medicine · 2025PMID 40421736Accessed 2 Oct 2026
  10. 10Mazdutide versus placebo in Chinese adults with type 2 diabetes.Nature · 2026PMID 41407859Accessed 2 Oct 2026
  11. 11Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.Nature · 2026PMID 41407860Accessed 2 Oct 2026
  12. 12Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial.The lancet. Diabetes & endocrinology · 2026PMID 42628555Accessed 2 Oct 2026
  13. 13Innovent announces NMPA (China) acceptance of the first mazdutide NDA, for chronic weight managementInnovent (press release via PR Newswire) · 2026Accessed 2 Oct 2026
  14. 14Innovent announces NMPA (China) acceptance of the second mazdutide NDA, for type 2 diabetesInnovent (press release via PR Newswire) · 2026Accessed 2 Oct 2026
  15. 15Innovent announces China's NMPA approved mazdutide for chronic weight management in adults with overweight or obesityInnovent (press release via PR Newswire) · 2026Accessed 2 Oct 2026

Found an error? Report a correction.