MariTide in Heart Failure Patients With Preserved or Mildly Reduced Ejection Fraction and Obesity
Research type
Research Study
Full title
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)
IRAS ID
1012255
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-516654-22
Research summary
Heart failure (HF) is a condition in which the heart is unable to pump blood effectively to meet the body's needs. HF can get worse over time, leading to an increased risk of earlier death, an increase in hospital admissions and poor quality of life. Obesity is excessive body fat that increases the risk of various health problems.
This study is being done to learn more about maridebart cafraglutide (MariTide) in participants with HF and obesity in addition to routine medical care (which may include medication, diet and exercise).
The study is divided into 2 parts (Part 1 and Part 2) that will be performed one after the other. Part 1 will check if MariTide is safe and better than placebo (a substance that looks like the medication being studied but has no active ingredients or direct medical effects) in reducing HF symptoms, reducing the frequency of hospital visits due to HF, reducing the number of heart attacks and stroke, and helping people live longer and see if it causes any undesirable effects. Part 1 is double-blind, meaning neither participants nor doctors will know whether each participant is receiving MariTide or placebo. Participants will be randomly assigned to a treatment group, meaning they will be placed in a group by chance, like flipping a coin. Patients who complete Part 1 will be offered the opportunity to take part in Part 2.
Part 2 of the study will continue to learn more about MariTide in participants with HF and obesity. Part 2 is an open label study, which means everyone, including participants, study doctors, and study staff will know that all participants are receiving MariTide. Participants will be in Part 1 of this study for around 2-3 years, and an additional 2 years if they choose to take part in Part 2.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0494
Date of REC Opinion
31 Jul 2025
REC opinion
Further Information Favourable Opinion