NCT07037433

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,800 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 45 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Conditions

• Atherosclerotic Cardiovascular Disease
• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Maridebart Cafraglutide	Maridebart cafraglutide will be administered SC.
DRUG	Placebo	Placebo will be administered SC.

Timeline

• Start date: 2025-07-25
• Primary completion: 2028-06-30
• Completion: 2030-09-29
• First posted: 2025-06-25
• Last updated: 2026-03-27

Locations

726 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study