Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 16, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07037459). This is a study registration, not published results. Lead sponsor: Amgen. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 5056 participants (ESTIMATED). Conditions: Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, Obesity. Interventions: DRUG: Maridebart cafraglutide; DRUG: Placebo. Primary outcome measures: Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events , Up to approximately 35 months. Brief 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.