drugset / Trial / NCT07037459

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

NCT07037459

Phase 3 Recruiting 5056 enrolled Amgen
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-06-25
Primary completion
2028-06-30
Completion
2030-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Maridebart Cafraglutide Unknown Subcutaneous