Maridebart Cafraglutide for Heart Failure and Obesity

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

Recruiting Phase 3 Interventional Study
Heart Failure With Preserved Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction Obesity
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,056 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for adults with heart failure and obesity. Participants will take a new treatment along with their usual heart failure care to see if it helps reduce heart failure problems.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesAcute pancreatitisChronic pancreatitisUncontrolled diabetes

You may be able to join if

  • I am 18 years or older.
  • I have a BMI of 30.0 or higher.
  • I have heart failure diagnosed for at least 30 days.
  • I have New York Heart Association Class II-IV heart failure.
  • I am using standard therapies for heart failure.
  • I had a left ventricular ejection fraction over 40% in the last year.

You may not be able to join if

  • I had a heart attack or major heart surgery in the last 60 days.
  • I have heart failure due to specific rare conditions.
  • I was hospitalized for acute heart failure during screening.
  • I have type 1 diabetes or uncontrolled type 2 diabetes.
  • I have high blood pressure not controlled with medication.
  • I have a history of pancreatitis in the last 180 days.
  • I have a personal or family history of medullary thyroid cancer.
  • I have serious mental health issues or a history of suicide attempts.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This trial 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, …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years at the time of informed consent. * BMI ≥ 30.0 kg/m\^2 at randomization. * HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent. * Managed with HF standard of care therapies. * Left ventricular eject…
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