Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and O… (NCT07037459) | Clinical Trial Compass
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
United States5,056 participantsStarted 2025-06-25
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Structural heart disease within 12 months prior to screening OR
✓. Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment \> 30 days and \< 12 months prior to randomization OR
✓. Evidence of elevated filling pressures within 12 months before randomization.
✕. 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 or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
What they're measuring
1
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events