Clinical trial

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

Recruiting now · Phase 3 · 3 countries · Registry ID NCT07037459

Recruiting nowPhase 3Interventional

What this study is about

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 promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionHeart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, Obesity

Full registry 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 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.

Treatments and study arms

Maridebart cafraglutide

Drug

Maridebart cafraglutide will be administered SC.

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF EventsUp to approximately 35 months

Heart Failure events include: hospitalization for HF or urgent HF visits.

Study locations

628 locations were listed when this page was built. The first 40 are shown.

Cemedic Centro de Especialidades Medicas🇦🇷 CABA, Buenos Aires, Argentina
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno🇦🇷 CABA, Buenos Aires, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada🇦🇷 CABA, Buenos Aires, Argentina
Centro de Investigaciones Metabolicas Cinme🇦🇷 CABA, Buenos Aires, Argentina
Fundacion Respirar - Consultorios Medicos Dr Doreski🇦🇷 CABA, Buenos Aires, Argentina
Imoba Investigaciones medicas🇦🇷 CABA, Buenos Aires, Argentina
Cardiología Palermo🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Ciprec Centro de Investigacion y Prevencion Cardiovascular🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Mautalen Salud e Investigacion Expertia SA-Osteo🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Damic🇦🇷 Córdoba, Argentina
Ciad - Consultorio Integral de Atencion al Diabetico🇦🇷 Morón, Buenos Aires, Argentina
Dim Clinica Privada🇦🇷 Ramos Meija, Buenos Aires, Argentina
INECO Neurociencias Oronio🇦🇷 Rosario, Argentina
Instituto CAICI - Centro de Asistencia e Investigacion Clinica Integral🇦🇷 Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta🇦🇷 Rosario, Santa Fe Province, Argentina
Centro Modelo de Cardiologia🇦🇷 San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman🇦🇷 San Miguel de Tucumán, Tucumán Province, Argentina
Go Centro Medico San Nicolas🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas de San Nicolas🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
Centro de Investigaciones Clinicas del Litoral🇦🇷 Santa Fe, Argentina
Hospital Dr Jose Maria Cullen🇦🇷 Santa Fe, Argentina
Clinica Fusavim Privada SRL🇦🇷 Villa María, Córdoba Province, Argentina
Instituto de Investigaciones Clinicas Zarate🇦🇷 Zárate, Argentina
Advara HeartCare Wesley🇦🇺 Auchenflower, Queensland, Australia
Flinders Medical Centre🇦🇺 Bedford Park, South Australia, Australia
Sunshine Coast University Hospital🇦🇺 Birtinya, Queensland, Australia
Victorian Heart Hospital🇦🇺 Clayton, Victoria, Australia
Canberra Hospital🇦🇺 Garran, Australian Capital Territory, Australia
Royal Brisbane and Womens Hospital🇦🇺 Herston, Queensland, Australia
Advara HeartCare Joondalup🇦🇺 Joondalup, Western Australia, Australia
Advara HeartCare Leabrook🇦🇺 Leabrook, South Australia, Australia
Sydney Cardiometabolic Centre🇦🇺 Liverpool, New South Wales, Australia
The Alfred Hospital🇦🇺 Melbourne, Victoria, Australia
Core Research Group Pty Ltd🇦🇺 Milton, Queensland, Australia
Advara HeartCare Mulgrave🇦🇺 Mulgrave, Victoria, Australia
Fiona Stanley Hospital🇦🇺 Murdoch, Western Australia, Australia
Gold Coast Hospital and Health Service🇦🇺 Southport, Queensland, Australia
Royal North Shore Hospital🇦🇺 St Leonards, New South Wales, Australia
Dr Heart Pty Ltd🇦🇺 Woolloongabba, Queensland, Australia
Krankenhaus Sankt Josef Braunau🇦🇹 Braunau am Inn, Austria