A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)
Amgen
Summary
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 2. Documented hospitalization with a primary diagnosis of…
Interventions
- DrugMaridebart cafraglutide
Maridebart cafraglutide will be administered SC.
- DrugPlacebo
Placebo will be administered SC.
Locations (603)
- University of Alabama at BirminghamBirmingham, Alabama
- SEC Clinical ResearchDothan, Alabama
- Eastern Shore Research InstituteFairhope, Alabama
- Heart Center Research LLCHuntsville, Alabama
- HonorHealthPhoenix, Arizona
- Medical Advancement Centers of ArizonaPhoenix, Arizona