Purpose of this Study
In the first part of the study, some people will get a new medicine called maridebart cafraglutide. They will get small shots that slowly increase in amount over 16 weeks. Other people will get a fake medicine called a placebo, but the shots will look the same.
After this first part, people who stay in the study can join the second part. In this part, everyone will get the real medicine for about 2 years. Doctors will keep checking to see how well the medicine works and if it is safe.
Who Can Participate?
Eligibility
To join the study, a person must:
- Be older than 18
- Have a body weight that is considered obese
- Have a heart that pumps more than 40% of its blood
- Never had a heart that pumped less than 40%
- Have a high level of a special substance in the blood that shows heart stress
- Also have at least one of these:
- A change in the shape or size of the heart
- Signs that the heart is having trouble filling with blood
- Been in the hospital for serious heart problems and needed strong medicine through a vein in the past year
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study wants to show that the new medicine, maridebart cafraglutide, works better than a fake medicine (called a placebo). It is given along with regular heart care. Doctors will check if it helps people feel better and move more easily by reducing heart failure symptoms.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
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
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
Principal Investigator
Stephen
Greene
Protocol Number
PRO00117973
NCT ID
NCT07037459
Phase
III
Enrollment Status
Pending Open to Enrollment