Maridebart Cafraglutide for Heart Failure and Obesity
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Recruiting
Phase 3Interventional Study
Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesity
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 outType 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, …
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, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
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…
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 ejection fraction (LVEF) of \> 40% within 12 months before randomization.
Exclusion Criteria:
* History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
* Hospitalized with acute decompensated HF at the time of or during the screening period.
* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
* For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
1. HbA1c \> 10.0% (86 mmol/mol) at screening
2. Uncontrolled diabetes requiring immediate therapy
3. History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization
4. One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
* SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \> 160 mmHg during the screening period (including day 1 prior to randomization).
* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
* Any personal lifetime history of, or family history(first-degree relative\[s\]) of medullary thyroid carcinoma or MEN-2.
* eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
* Calcitonin ≥ 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis.
* Any of the following psychiatric history:
1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
2. Lifetime history of suicide attempt
3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.
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