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MariTide: Trials and FDA Status

MariTide is a glp-1 agonist / gipr antagonist antibody-peptide. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledmaridebart cafraglutide
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational
Phase
Phase 3
Sponsor
Amgen
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT05669599, NCT06858839, NCT06858878
Results

Reported results

  • 2025Phase 2 (NEJM 2025): obesity cohort weight change at 52 weeks (treatment policy estimand)“the mean percent change in body weight from baseline to week 52 on the basis of the treatment policy estimand (intention-to-treat approach) ranged from -12.3% (95% confidence interval [CI], -15.0 to -9.7) to -16.2% (95% CI, -18.9 to -13.5) with maridebart cafraglutide, as compared with -2.5% (95% CI, -4.2 to -0.7) with placebo”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. NCT06858839 (MARITIME-1; Phase 3): primary completion (estimated)
  2. NCT06858878 (MARITIME-2; Phase 3): primary completion (estimated)
  3. Amgen reports 52-week phase 2 MariTide results and that the MARITIME phase 3 chronic weight management studies are actively enrolling
  4. NCT06858878 (MARITIME-2; Phase 3): study start
  5. NCT06858839 (MARITIME-1; Phase 3): study start
  6. NCT06858839 (MARITIME-1; Phase 3): first posted on ClinicalTrials.gov
  7. NCT06858878 (MARITIME-2; Phase 3): first posted on ClinicalTrials.gov
  8. Published in The New England journal of medicine (2025): Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial.
  9. NCT05669599 (Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus; Phase 2): primary completion
  10. NCT05669599 (Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus; Phase 2): study start
  11. NCT05669599 (Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus; 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. 1Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus (NCT05669599)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  2. 2MARITIME-1: Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (NCT06858839)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
  3. 3MARITIME-2: Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (NCT06858878)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
  4. 4Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial.The New England journal of medicine · 2025PMID 40549887Accessed 2 Oct 2026
  5. 5Amgen reports 52-week phase 2 MariTide results and that the MARITIME phase 3 chronic weight management studies are actively enrollingAmgen (press release) · 2026amgen.comAccessed 2 Oct 2026

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