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

ID#: NCT07037459

Age: 18 - 99 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: June 25, 2025

End Date: September 29, 2030

Contact Information:
Amgen Call Center
866-572-6436
Summary: This study 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 study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
Eligibility:

Inclusion Criteria:

- Age ≥ 18 years.

- BMI ≥ 30 kg/m^2.

- HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.

- Managed with HF standard of care therapies.

- Left ventricular ejection fraction (LVEF) of > 40%.

- Elevated NT-proBNP.

- Participants must have at least one of the following:

1. Structural heart disease OR

2. Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR

3. Evidence of elevated filling pressures within 12 months before randomization.

Exclusion Criteria:

- History of any of the following within 60 days before 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 myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular heart disease, or clinically significant congenital heart disease.

- Any lifetime history of LVEF ≤ 40%.

- Currently hospitalized with acute decompensated HF or hospitalization with a primary diagnosis of decompensated HF within 30 days before screening.

- 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 at screening:

1. HbA1c > 10.0%

2. Uncontrolled diabetes requiring immediate therapy

3. History of diabetic ketoacidosis or hyperosmolar state/coma

4. One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness

5. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.

- SBP ≥ 180 mmHg , or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg.

- History of chronic pancreatitis or acute pancreatitis in the 180 days before screening.

- Family (or personal) history 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 before screening

2. Lifetime history of suicide attempt

3. History of non-suicidal self-injury within 5 years before screening.

- History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.

- 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 before randomization or planned use during the conduct of the study.
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