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

What this Trial Is About

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This phase 3 global trial aims to see if this drug can reduce serious heart failure events like hospitalizations, urgent visits, and cardiovascular deaths, while improving heart failure symptoms. The study is event-driven and includes a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial consists of two parts, with Part 1 ending when about 850 primary endpoint events have occurred. The study includes a double-blind treatment period and an open-label extension phase where all participants can receive the drug. During the trial, participants will undergo regular assessments including measurements of heart failure events, cardiovascular deaths, and symptom changes using the Kansas City Cardiomyopathy Questionnaire. Other evaluations include blood pressure, body measurements, kidney function, cholesterol, and blood markers related to heart failure and diabetes. The primary outcome is the time to the first cardiovascular death or heart failure event, measured over up to approximately 35 months. Safety and drug levels will also be monitored throughout the study.

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