RecruitingHeart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesity

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Eligible age

18–99 yrs

Accepts

All genders

Locations

30 states

Healthy volunteers

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About this study

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Sponsor: Amgen

You may qualify if…

✓ Age ≥ 18 years at the time of informed consent.
✓ BMI ≥ 30.0 kg/m\^2 at the time of randomization.
✓ HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
✓ Managed with HF standard of care therapies.
✓ Left ventricular ejection fraction (LVEF) of \> 40% within 12 months from the beginning of screening.
✓ Elevated NT-proBNP.
✓ Participants must have at least one of the following:
✓ 1. Structural heart disease within 12 months prior to screening OR

You may not qualify if…

✕ History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
✕ HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
✕ Any lifetime history of LVEF ≤ 40%.
✕ Hospitalized with acute decompensated HF at the time of or during the screening period.
✕ Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
✕ For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
✕ 1. HbA1c \> 10.0% (86 mmol/mol) at screening
✕ 2. Uncontrolled diabetes requiring immediate therapy