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] (NCT07037459)

This study 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 study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof David Kaye

Key inclusion data

Inclusion Criteria: Age ? 18 years; BMI ? 30 kg/m^2; HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV; Managed with HF standard of care therapies; Left ventricular ejection fraction (LVEF) of > 40%; Elevated NT-proBNP. Participants must have at least one of the following: Structural heart disease OR; Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR; Evidence of elevated filling pressures within 12 months before randomization.