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CagriSema: Trials and FDA Status

CagriSema is a amylin + glp-1 combination. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledcagrilintide + semaglutide
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational · filed with FDA
Phase
Phase 3
Sponsor
Novo Nordisk
Expected FDA decision
Sponsor statement
Novo Nordisk states the FDA is expected to review the CagriSema application in 2026 (no decision date given).
Trial IDs (NCT)
NCT04982575, NCT05567796, NCT05394519, NCT05669755
Results

Reported results

  • 2025REDEFINE 1 phase 3 (NEJM 2025): weight change at 68 weeks vs placebo“The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo”pubmed.ncbi.nlm.nih.gov
  • 2 Feb 2026REIMAGINE 2 (type 2 diabetes) headline result, company-reported“CagriSema achieved superior weight loss of up to 14.2%, where up to 43% of the people achieved ≥15% weight loss and up to 24% achieved ≥20% weight loss”Novo Nordisk (press release)

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

Expected decision: Novo Nordisk states the FDA is expected to review the CagriSema application in 2026 (no decision date given).

  1. NCT05669755 (REDEFINE 3; Phase 3): primary completion (estimated)
  2. Novo Nordisk announces REIMAGINE 2 phase 3 headline results
  3. Published in The lancet. Diabetes & endocrinology (2026): Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial.
  4. Novo Nordisk announces submission of a New Drug Application to the U.S. FDA for CagriSema
  5. NCT05394519 (REDEFINE 2; Phase 3): primary completion
  6. Published in The New England journal of medicine (2025): Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.
  7. Published in The New England journal of medicine (2025): Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.
  8. NCT05567796 (REDEFINE 1; Phase 3): primary completion
  9. NCT05669755 (REDEFINE 3; Phase 3): study start
  10. NCT05394519 (REDEFINE 2; Phase 3): study start
  11. NCT05669755 (REDEFINE 3; Phase 3): first posted on ClinicalTrials.gov
  12. Published in Lancet (London, England) (2023): Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.
  13. NCT05567796 (REDEFINE 1; Phase 3): study start
  14. NCT05567796 (REDEFINE 1; Phase 3): first posted on ClinicalTrials.gov
  15. NCT04982575 (Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes; Phase 2): primary completion
  16. NCT05394519 (REDEFINE 2; Phase 3): first posted on ClinicalTrials.gov
  17. NCT04982575 (Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes; Phase 2): study start
  18. NCT04982575 (Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes; Phase 2): first posted on ClinicalTrials.gov

What people search

  • cagrisema trial50/mo
  • cagrisema fda approval50/mo
  • cagrisema clinical trials40/mo
  • is cagrisema fda approved30/mo
  • cagrisema phase 330/mo
  • cagrisema results20/mo

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

Sources

  1. 1Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes (NCT04982575)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  2. 2REDEFINE 1: A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (NCT05567796)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  3. 3REDEFINE 2: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (NCT05394519)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  4. 4REDEFINE 3: REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels (NCT05669755)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  5. 5Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.Lancet (London, England) · 2023PMID 37364590Accessed 2 Oct 2026
  6. 6Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.The New England journal of medicine · 2025PMID 40544433Accessed 2 Oct 2026
  7. 7Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.The New England journal of medicine · 2025PMID 40544432Accessed 2 Oct 2026
  8. 8Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial.The lancet. Diabetes & endocrinology · 2026PMID 42009015Accessed 2 Oct 2026
  9. 9Novo Nordisk announces submission of a New Drug Application to the U.S. FDA for CagriSemaNovo Nordisk (press release) · 2026Accessed 2 Oct 2026
  10. 10Novo Nordisk announces REIMAGINE 2 phase 3 headline resultsNovo Nordisk (press release) · 2026Accessed 2 Oct 2026

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