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Dapiglutide: Trials and FDA Status

Dapiglutide is a glp-1/glp-2 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
Phase 2
Sponsor
University Hospital, Gentofte, Copenhagen
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT05788601
Results

Reported results

  • 2026Phase 2a (Lancet Diabetes Endocrinol 2026): weight change vs placebo at week 12“In the primary efficacy analysis, 6 mg dapiglutide led to a mean bodyweight change of -2·1% [95% CI -4·3 to 0·2; p = 0·076]”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. Published in EClinicalMedicine (2026): Dapiglutide, a dual GLP-1 and GLP-2 receptor agonist, for obesity: a randomised, double-blind, placebo-controlled parallel-group, proof-of-concept trial.
  2. NCT05788601 (DREAM; Phase 2): primary completion
  3. NCT05788601 (DREAM; Phase 2): study start
  4. NCT05788601 (DREAM; Phase 2): first posted on ClinicalTrials.gov

Sources

  1. 1DREAM: Dapiglutide for the Treatment of Obesity (NCT05788601)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  2. 2Dapiglutide, a dual GLP-1 and GLP-2 receptor agonist, for obesity: a randomised, double-blind, placebo-controlled parallel-group, proof-of-concept trial.EClinicalMedicine · 2026PMID 41768273Accessed 2 Oct 2026

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