RecruitingAtherosclerotic Cardiovascular DiseaseOverweightObesity

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

Eligible age

45–99 yrs

Accepts

All genders

Locations

36 states

Healthy volunteers

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About this study

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.

Sponsor: Amgen

You may qualify if…

✓ 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 procedure, or amputation due to atherosclerotic disease.

You may not qualify if…

✕ History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
✕ New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
✕ Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
✕ For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
✕ HbA1c \> 10.0% (86 mmol/mol) at screening.
✕ History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
✕ One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
✕ History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.