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Pipeline › petrelintide

petrelintide

Not FDA-approved, and in phase 2 development, not authorised in the European Union. 4 active trials, the next due to complete 2027-11-12.

amylin agonist, SC, from Zealand Pharma. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.

Status
phase2
Target
amylin
Route
SC
Sponsor
Zealand Pharma
First FDA approval
Not approved
EU authorisation
Not authorised
Active trials
4 (3 in phase 3)
Participants enrolled
7,486
Trials with a reporting date
3
Approved FDA submissions
0

Recent changes

DetectedChangeTrialDetailPhase
2026-10-07Status changedA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
NCT07843472 · Hoffmann-La Roche
Not yet recruiting → RecruitingP3
2026-10-07Status changedA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
NCT07843498 · Hoffmann-La Roche
Not yet recruiting → RecruitingP3
2026-10-07Status changedA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
NCT07843485 · Hoffmann-La Roche
Not yet recruiting → RecruitingP3
2026-09-28New trial registeredA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
NCT07843472 · Hoffmann-La Roche
Not yet recruiting, n=2,500P3
2026-09-28New trial registeredA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
NCT07843485 · Hoffmann-La Roche
Not yet recruiting, n=600P3
2026-09-28New trial registeredA Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
NCT07843498 · Hoffmann-La Roche
Not yet recruiting, n=3,900P3
2026-09-09Status changedEfficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
NCT06926842 · Zealand Pharma
Active, not recruiting → CompletedP2

When these trials report

01Q4 26: 0 trials reportingQ1 27: 0 trials reportingQ2 27: 0 trials reportingQ3 27: 0 trials reportingQ4 27: 1 trial reportingQ1 28: 0 trials reportingQ2 28: 0 trials reportingQ3 28: 0 trials reportingQ4 26Q1 27Q2 27Q3 271Q4 27Q1 28Q2 28Q3 28
When trials are due to report, by quarter — hover a bar for the count. These dates are filed by the sponsor and often move.

Next 3 of 3 active trials by estimated primary completion.

Est. completionTrialSponsorPhaseParticipants
2027-11-12A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
NCT07589686 · Percentage Change in Body Weight between Arms 1 and 6
Hoffmann-La RocheP2486
2028-10-20A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
NCT07843485 · Percentage Change in Body Weight from Baseline
Hoffmann-La RocheP3600
2028-12-21A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
NCT07843498 · Percentage Change in Body Weight from Baseline
Hoffmann-La RocheP33,900

Indications under study

Cardiovascular Disease; Obesity or Overweight; Type 2 Diabetes.

Recent papers

PublishedTitleJournal
2026-09-29Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial
Garvey WT, Ard J, Connery L, Frias JP, le Roux CW, Pietiläinen KH, Dinesen M, Hagen BF, Larsen L, Hesse D, Kendall DM.
Lancet Diabetes Endocrinol
2026-09-29Petrelintide and the evolving role of amylin agonism in obesity
Madsbad S, Holst JJ.
Lancet Diabetes Endocrinol
2026-04-22Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials
Brændholt Olsen M, Griffin J, Hövelmann U, Macura S, Fredsted Hagen B, Hesse D, Heise T.
Diabetes Obes Metab
2025-11-11Development of Petrelintide: a Potent, Stable, Long-Acting Human Amylin Analogue
Fischer Munch H, Just R, Mosolff Mathiesen J, Eriksson PO, Skodborg Villadsen J, Vestergaard B, Deryabina M, Demmer O, Skarbaliene J, Hamprecht DW, Rist W, Baader-Pagler T, Grube A, Heim-Riether A, Giehm L.
J Med Chem

Every petrelintide trial on file

All 6 registered trials of petrelintide, largest first. Each links to its own page and to the registry record.

TrialStatusPhaseParticipants
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
NCT07843498 · Hoffmann-La Roche
RecruitingP33,900
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
NCT07843472 · Hoffmann-La Roche
RecruitingP32,500
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
NCT07843485 · Hoffmann-La Roche
RecruitingP3600
Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
NCT06662539 · Zealand Pharma
CompletedP2493
A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
NCT07589686 · Hoffmann-La Roche
Not yet recruitingP2486
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
NCT06926842 · Zealand Pharma
CompletedP2221

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