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Survodutide: Trials and FDA Status

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

Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational · phase 3
Phase
Phase 3
Sponsor
Boehringer Ingelheim
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT04667377, NCT04153929, NCT04771273, NCT06066515, NCT06066528
Results

Reported results

  • 2026SYNCHRONIZE-1 phase 3 (NEJM 2026): weight change at 76 weeks“At week 76, the mean change in body weight from baseline according to the treatment-regimen estimand was -12.2% (95% confidence interval [CI], -13.6 to -10.8) in the 3.6-mg group, -13.0% (95% CI, -14.4 to -11.6) in the 6.0-mg group, and -5.4% (95% CI, -6.9 to -4.0) in the placebo group”pubmed.ncbi.nlm.nih.gov
  • 2026SYNCHRONIZE-2 phase 3 (NEJM 2026): weight change at 76 weeks in type 2 diabetes“The mean weight change at week 76 according to the treatment-regimen estimand (which assessed effects regardless of whether the trial regimen was discontinued or interrupted or whether other antiobesity therapies were used) was -8.2% (95% confidence interval [CI], -9.2 to -7.2) in the 3.6-mg group, -9.8% (95% CI, -10.8 to -8.8) in the 6.0-mg group, and -3.9% (95% CI, -4.9 to -2.9) 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 The New England journal of medicine (2026): Survodutide Once Weekly for the Treatment of Adults with Obesity.
  3. Published in The New England journal of medicine (2026): Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes.
  4. Published in Nature medicine (2026): Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial.
  5. NCT06066528 (SYNCHRONIZE™-2; Phase 3): primary completion
  6. NCT06066515 (SYNCHRONIZE™-1; Phase 3): primary completion
  7. Published in The lancet. Diabetes & endocrinology (2024): Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.
  8. Published in The New England journal of medicine (2024): A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis.
  9. NCT06066528 (SYNCHRONIZE™-2; Phase 3): study start
  10. NCT06066515 (SYNCHRONIZE™-1; Phase 3): study start
  11. NCT04771273 (A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3); Phase 2): primary completion
  12. NCT06066515 (SYNCHRONIZE™-1; Phase 3): first posted on ClinicalTrials.gov
  13. NCT06066528 (SYNCHRONIZE™-2; Phase 3): first posted on ClinicalTrials.gov
  14. NCT04667377 (A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight; Phase 2): primary completion
  15. NCT04153929 (A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.; Phase 2): primary completion
  16. NCT04771273 (A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3); Phase 2): study start
  17. NCT04667377 (A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight; Phase 2): study start
  18. NCT04771273 (A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3); Phase 2): first posted on ClinicalTrials.gov
  19. NCT04667377 (A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight; Phase 2): first posted on ClinicalTrials.gov
  20. NCT04153929 (A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.; Phase 2): study start
  21. NCT04153929 (A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.; Phase 2): first posted on ClinicalTrials.gov

What people search

  • survodutide phase 350/mo
  • survodutide fda approval40/mo
  • survodutide clinical trials40/mo
  • survodutide results20/mo
  • survodutide news10/mo

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

Sources

  1. 1A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight (NCT04667377)ClinicalTrials.gov (U.S. National Library of Medicine) · 2020clinicaltrials.govAccessed 2 Oct 2026
  2. 2A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes. (NCT04153929)ClinicalTrials.gov (U.S. National Library of Medicine) · 2019clinicaltrials.govAccessed 2 Oct 2026
  3. 3A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) (NCT04771273)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  4. 4SYNCHRONIZE™-1: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (NCT06066515)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  5. 5SYNCHRONIZE™-2: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight (NCT06066528)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. 7Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.The lancet. Diabetes & endocrinology · 2024PMID 38330987Accessed 2 Oct 2026
  8. 8A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis.The New England journal of medicine · 2024PMID 38847460Accessed 2 Oct 2026
  9. 9Survodutide Once Weekly for the Treatment of Adults with Obesity.The New England journal of medicine · 2026PMID 42253238Accessed 2 Oct 2026
  10. 10Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes.The New England journal of medicine · 2026PMID 42820639Accessed 2 Oct 2026
  11. 11Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial.Nature medicine · 2026PMID 42252333Accessed 2 Oct 2026

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