Last updated 22 days ago

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

5056 patients around the world

Available in Argentina, United States

Amgen

40Research sites

5056Patients around the world

This study is for people with

Heart failure

Obesity

Requirements for the patient

To 99 Years

All Gender

Medical requirements

: Age ≥ 18 years.
BMI ≥ 30 kg/m².
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:
Structural heart disease.
Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization.
Evidence of elevated filling pressures within 12 months before randomization.

: 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:
HbA1c > 10.0%.
Uncontrolled diabetes requiring immediate therapy.
History of diabetic ketoacidosis or hyperosmolar state/coma.
One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness.
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 m² (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:
History of unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening.
Lifetime history of suicide attempt.
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.