Purpose:
This Phase III clinical trial is testing a new medication called Maridebart Cafraglutide (MariTide). It aims to see how effective and safe MariTide is in reducing heart failure complications and improving survival in people with obesity and heart failure.
Heart failure, especially a type called HFpEF (Heart Failure with Preserved Ejection Fraction) or "stiff heart syndrome," is becoming more common. Obesity may play a big role in its development. Early studies suggest that medications like MariTide, which help regulate weight and metabolism, could also improve heart health.
Description:
MariTide is a cutting-edge medication that combines two powerful effects:
1. Helps with weight loss: Clinical studies showed up to 20% weight loss in patients without type 2 diabetes over one year.
2. Improves heart health: It regulates blood sugar, reduces inflammation, and lowers blood pressure and cholesterol..
Key Eligibility Requirements:
(Please note: Additional eligibility requirements may be assessed at the time of study screening evaluation.)
You may qualify if you:
• Are 18 years or older.
• Have chronic heart failure symptoms like shortness of breath, fatigue, or swelling.
• Have a heart function measure called left ventricular ejection fraction of 40% or higher.
• Meet specific weight (BMI) and heart health markers (NT-proBNP levels).
You may not qualify if you:
• Have certain types of diabetes or uncontrolled blood sugar.
• Use medications for weight loss or specific diabetes treatments.
• Have severe kidney issues, high blood pressure, or recent cancer diagnoses.
What Will the Study Involve?
Participants will be randomly assigned to one of two groups:
• Group 1: Receive MariTide.
• Group 2: Receive a placebo (inactive treatment).
Both groups will continue their standard heart failure treatments. After the first phase, all participants can receive MariTide in an open-label phase.
Why Join This Trial?
• Access to cutting-edge care: Be among the first to try a potential new treatment for obesity and heart failure.
• Comprehensive monitoring: Benefit from close follow-ups and expert medical care during the study.
• Make a difference: Help advance research to improve care for millions of people worldwide.
PARTICIPATION IN THIS TRIAL CAN BE UP TO TWO YEARS
The information we are providing includes important background on a variety of important cardiovascular conditions and ongoing clinical trials. We encourage you to use this information in discussions with your health care professional. Since enrollment in clinical trials are limited in time, we can’t guarantee their availability at any given time. However, we have continued access to new clinical trial opportunities and will share them as soon as they are available.