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Cagrilintide: Trials and FDA Status

Cagrilintide is a amylin analog. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

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

Where it stands

US status
Investigational (CagriSema component)
Phase
Phase 3
Sponsor
Novo Nordisk
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT03856047, NCT07220642, NCT07220759
Results

Reported results

  • 2021Phase 2 (Lancet 2021): weight change vs placebo and liraglutide“According to the trial product estimand, mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8% [6·4-11·5 kg]) versus placebo (3·0% [3·3 kg]; estimated treatment difference range 3·0%-7·8%; p<0·001)”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. NCT07220759 (RENEW 2; Phase 3): primary completion (estimated)
  2. NCT07220642 (RENEW 1; Phase 3): primary completion (estimated)
  3. NCT07220642 (RENEW 1; Phase 3): study start
  4. NCT07220759 (RENEW 2; Phase 3): study start
  5. NCT07220642 (RENEW 1; Phase 3): first posted on ClinicalTrials.gov
  6. NCT07220759 (RENEW 2; Phase 3): first posted on ClinicalTrials.gov
  7. Published in Lancet (London, England) (2021): Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.
  8. Published in Lancet (London, England) (2021): Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial.
  9. NCT03856047 (Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.; Phase 2): primary completion
  10. NCT03856047 (Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.; Phase 2): study start
  11. NCT03856047 (Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.; Phase 2): first posted on ClinicalTrials.gov

What people search

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

Sources

  1. 1Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity. (NCT03856047)ClinicalTrials.gov (U.S. National Library of Medicine) · 2019clinicaltrials.govAccessed 2 Oct 2026
  2. 2RENEW 1: Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide (NCT07220642)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
  3. 3RENEW 2: Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide (NCT07220759)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
  4. 4Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.Lancet (London, England) · 2021PMID 34798060Accessed 2 Oct 2026
  5. 5Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial.Lancet (London, England) · 2021PMID 33894838Accessed 2 Oct 2026

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