Study S001869

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

ClinicalTrials.gov record

Registration

Registration: NCT07037433
Acronym: MARITIME-CV
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 12800
Start: 2025-07-25
Primary completion: 2028-06-30
Lead sponsor: Amgen
Conditions: Atherosclerotic Cardiovascular Disease; Overweight; Obesity
Interventions: DRUG:Maridebart Cafraglutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

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]) [Up to approximately 35 months]
Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE) [Up to approximately 35 months]

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