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maridebart cafraglutide
Not FDA-approved, and in phase 2 development, not authorised in the European Union. 12 active trials, the next due to complete 2027-01-21.
GIP antagonist/GLP-1 agonist, SC, from Amgen.
Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage
Database, the EMA register or Europe PMC, and re-checked every four hours.
Status phase2
Target GIP antagonist/GLP-1
Route SC
Sponsor Amgen
Brand names Maritide
First FDA approval Not approved
EU authorisation Not authorised
Active trials 12 (10 in phase 3)
Participants enrolled 28,632
Trials with a reporting date 11
Approved FDA submissions 0 Recent changes When these trials report
2 3 Q3 26: 0 trials reporting Q4 26: 0 trials reporting Q1 27: 2 trials reporting, 2 phase 3 Q2 27: 1 trial reporting, 1 phase 3 Q3 27: 3 trials reporting, 2 phase 3 Q4 27: 2 trials reporting, 2 phase 3 Q1 28: 1 trial reporting, 1 phase 3 Q2 28: 2 trials reporting, 2 phase 3 Q3 26 Q4 26 Q1 27 Q2 27 3 Q3 27 Q4 27 Q1 28 Q2 28
When trials are due to report, by quarter — hover a bar for the count.
These dates are filed by the sponsor and often move.
Next 11 of 11 active trials by estimated primary completion.
Est. completion Trial Sponsor Phase Participants 2027-01-21 Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight NCT06858878 · Percent Change from Baseline in Body Weight at Week 72
Amgen P3 1,105 2027-01-21 Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight NCT06858839 · Percent Change From Baseline in Body Weight at Week 72
Amgen P3 3,853 2027-04-27 Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease NCT06987695 · Percent Change From Baseline in Body Weight at Week 72
Amgen P3 279 2027-09-29 A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight NCT07441252 · Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Amgen P2 180 2027-09-29 Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy NCT07226765 · Change in Apnea-hypopnea Index (AHI) from baseline at Week 52
Amgen P3 250 2027-09-29 Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy NCT07225686 · Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
Amgen P3 250 2027-12-26 Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION) NCT07684235 · Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Amgen P3 3,200 2027-12-26 Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION) NCT07684144 · Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Amgen P3 950 2028-01-03 Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH) NCT07575399 · Percent Change from Baseline in Body Weight at Week 68
Amgen P3 300 2028-06-30 Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity NCT07037433 · Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])
Amgen P3 12,800 2028-06-30 Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity NCT07037459 · Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events
Amgen P3 5,056
Indications under study Atherosclerotic Cardiovascular Disease; Diabetes Mellitus, Type 2; Heart Failure With Mildly Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Obesity; Obesity Disease; Obesity or Overweight; Obstructive Sleep Apnea; Overweight; Overweight or Obesity and Elevated Liver Fat; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight.
Recent papers Published Title Journal 2026-06-01 Design and therapeutic rationale of antibody-peptide conjugates: insights from maridebart cafraglutide (AMG133) and emerging applications Yie J, Mou Z, Liu X.
Antib Ther 2025-12-01 Once-Monthly Maridebart Cafraglutide in Obesity - A Phase 2 Trial. Reply Jastreboff AM, Ryan DH, Pannacciulli N.
N Engl J Med 2025-06-23 Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial Jastreboff AM, Ryan DH, Bays HE, Ebeling PR, Mackowski MG, Philipose N, Ross L, Liu Y, Burns CE, Abbasi SA, Pannacciulli N, MariTide Phase 2 Obesity Trial Investigators.
N Engl J Med
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