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
Amgen
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.
Eligibility
- Age range
- 45–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Age ≥ 45 years at screening. * BMI of ≥ 27.0 kg/m\^2 at screening. * History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following: * Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). * Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation). * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization proced…
Interventions
- DrugMaridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
- DrugPlacebo
Placebo will be administered SC.
Locations (759)
- Alliance For Multispecialty Research - DaphneDaphne, Alabama
- Eastern Shore Research InstituteFairhope, Alabama
- Heart Center Research LLCHuntsville, Alabama
- Mobile Heart Specialists PCMobile, Alabama
- Syed Research Consultants LLCSheffield, Alabama
- Synexus Clinical Research US, Inc.Phoenix, Arizona