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Petrelintide: Trials and FDA Status

Petrelintide is a amylin analog. 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
Phase 3 (registered, not yet recruiting)
Sponsor
Zealand Pharma / Roche
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT06662539, NCT06926842, NCT07843498, NCT07843485
Results

Reported results

  • 2026ZUPREME-1 phase 2 (Lancet Diabetes Endocrinol 2026): weight change at 28 weeks (efficacy estimand)“Mean percentage change in bodyweight from baseline after 28 weeks (efficacy estimand) was -7·9% (95% CI -9·0 to -6·7) with petrelintide 1·0 mg, -7·9% (-9·0 to -6·7) with petrelintide 2·5 mg, -9·8% (-10·9 to -8·6) with petrelintide 5·0 mg, -9·3% (-10·5 to -8·2) with petrelintide 7·0 mg, and -9·4% (-10·5 to -8·3) with petrelintide 9·0 mg versus -1·7% (-2·8 to -0·5) with placebo”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. NCT07843498 (ZUPREME-3; Phase 3): primary completion (estimated)
  2. NCT07843485 (ZUPREME-4; Phase 3): primary completion (estimated)
  3. NCT07843498 (ZUPREME-3; Phase 3): study start (estimated)
  4. NCT07843485 (ZUPREME-4; Phase 3): study start (estimated)
  5. NCT07843498 (ZUPREME-3; Phase 3): first posted on ClinicalTrials.gov
  6. NCT07843485 (ZUPREME-4; Phase 3): first posted on ClinicalTrials.gov
  7. NCT06926842 (Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2); Phase 2): primary completion
  8. Published in Diabetes, obesity & metabolism (2026): Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials.
  9. Published in The lancet. Diabetes & endocrinology (2026): Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial.
  10. NCT06662539 (ZUPREME; Phase 2): primary completion
  11. NCT06926842 (Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2); Phase 2): study start
  12. NCT06926842 (Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2); Phase 2): first posted on ClinicalTrials.gov
  13. NCT06662539 (ZUPREME; Phase 2): study start
  14. NCT06662539 (ZUPREME; Phase 2): first posted on ClinicalTrials.gov

What people search

  • petrelintide phase 310/mo

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

Sources

  1. 1ZUPREME: Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities (NCT06662539)ClinicalTrials.gov (U.S. National Library of Medicine) · 2024clinicaltrials.govAccessed 2 Oct 2026
  2. 2Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2) (NCT06926842)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
  3. 3ZUPREME-3: A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity (NCT07843498)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
  4. 4ZUPREME-4: A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (NCT07843485)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
  5. 5Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials.Diabetes, obesity & metabolism · 2026PMID 42017294Accessed 2 Oct 2026
  6. 6Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial.The lancet. Diabetes & endocrinology · 2026PMID 42810355Accessed 2 Oct 2026

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