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

A vizsgálat adatai

Ki végzi

Amgen

Azonosító

NCT07037459

A regiszteradat frissítve

2026. október 29.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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 (MARITIME-HF)

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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; 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 of the following psychiatric history:; History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period; Lifetime history of suicide attempt; History of non-suicidal self-injury within 5 years prior to screening or during the screening period; 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; Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes; Any personal lifetime history of, or family history(first-degree relative[s]) of medullary thyroid carcinoma or MEN-2; Acute or chronic hepatitis; History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial; For participants with a prior diagnosis of T2DM (including those diagnosed during screening):; HbA1c > 10.0% (86 mmol/mol) at screening; Uncontrolled diabetes requiring immediate therapy; History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization; One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness; 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; eGFR < 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening; 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; Hospitalized with acute decompensated HF at the time of or during the screening period; Calcitonin ≥ 50 ng/L (pg/mL) at screening.

ClinicalTrials.gov NCT07037459