Skip to content
Peptigraph home

Amycretin: Trials and FDA Status

Amycretin is a glp-1/amylin unimolecular agonist. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledzenagamtideNNC0487-0111
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational
Phase
Phase 3
Sponsor
Novo Nordisk
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT06064006, NCT06542874, NCT07339423, NCT07533175
Results

Reported results

  • 2025Phase 1b/2a (Lancet 2025): estimated mean body-weight change vs placebo“Estimated mean bodyweight change from baseline was significantly (Parts A-D: p<0·0001; Part E: p=0·0003) higher with amycretin versus placebo in Part B (60 mg, -24·3% vs -1·1%; week 36), Part C (20 mg, -22·0% vs 1·9%; week 36), Part D (5 mg, -16·2% vs 2·3%; week 28), and Part E (1·25 mg, -9·7% vs 2·0%; week 20)”pubmed.ncbi.nlm.nih.gov
  • 2026Phase 2 in type 2 diabetes, once-weekly subcutaneous (Lancet 2026): HbA1c at week 36“At week 36, estimated change in HbA1c (mean across all groups at baseline 7·8% [SD 0·8]) ranged from -0·9% with zenagamtide 0·4 mg (estimated treatment difference vs placebo: -0·77% [95% CI -1·26 to -0·28]; p=0·0021) to -1·7% with zenagamtide 40 mg (-1·56% [-2·05 to -1·07]; p<0·0001)”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. NCT07339423 (AMAZE 1; Phase 3): primary completion (estimated)
  2. NCT07533175 (AMAZE 2; Phase 3): primary completion (estimated)
  3. NCT07533175 (AMAZE 2; Phase 3): first posted on ClinicalTrials.gov
  4. NCT07533175 (AMAZE 2; Phase 3): study start
  5. NCT07339423 (AMAZE 1; Phase 3): study start
  6. NCT07339423 (AMAZE 1; Phase 3): first posted on ClinicalTrials.gov
  7. Published in Lancet (London, England) (2026): Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.
  8. Published in Lancet (London, England) (2026): Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.
  9. NCT06542874 (A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes; Phase 2): primary completion
  10. Novo Nordisk announces it will advance subcutaneous and oral amycretin into phase 3 development in weight management
  11. Published in Lancet (London, England) (2025): Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study.
  12. NCT06064006 (A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin; Phase 2): primary completion
  13. NCT06542874 (A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes; Phase 2): first posted on ClinicalTrials.gov
  14. NCT06542874 (A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes; Phase 2): study start
  15. NCT06064006 (A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin; Phase 2): first posted on ClinicalTrials.gov
  16. NCT06064006 (A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin; Phase 2): study start

What people search

  • amycretin phase 320/mo
  • amycretin results10/mo
  • amycretin release date10/mo
  • amycretin news10/mo

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

Sources

  1. 1Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetesThe Lancet · 2026PMID 42532080Accessed 2 Oct 2026
  2. 2A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin (NCT06064006)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  3. 3A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes (NCT06542874)ClinicalTrials.gov (U.S. National Library of Medicine) · 2024clinicaltrials.govAccessed 2 Oct 2026
  4. 4AMAZE 1: AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight (NCT07339423)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
  5. 5AMAZE 2: AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight (NCT07533175)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
  6. 6Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study.Lancet (London, England) · 2025PMID 40550231Accessed 2 Oct 2026
  7. 7Novo Nordisk announces it will advance subcutaneous and oral amycretin into phase 3 development in weight managementNovo Nordisk (press release) · 2026novonordisk.comAccessed 2 Oct 2026
  8. 8Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.Lancet (London, England) · 2026PMID 42532079Accessed 2 Oct 2026

Found an error? Report a correction.