Recruiting NCT07037459

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

Phase III Interventional Heart Failure With Preserved Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Maridebart cafraglutide, Placebo.
Who it may be relevant to: Registry conditions: Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, Obesity. Basic parameters: 18 years — 99 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +29
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

Drug Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Drug Placebo
Placebo will be administered SC.

Primary outcome measures

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events [Time frame: Up to approximately 35 months]

Secondary outcome measures (12)

Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) for Participants with Baseline KCCQ-CSS Score ≤ 80 [Time frame: Baseline and Week 48]
Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80 [Time frame: Baseline and Week 48]
Total Number of HF Events Including First and Recurrent HF Events [Time frame: Up to approximately 35 months]
Time to First Occurrence of a Composite Endpoint Consisting of: Myocardial Infarction (MI), Ischemic Stroke, CV Death (Major Adverse Cardiac Events [MACE]), or HF Events [Time frame: Up to approximately 35 months]
Time to First Event of a Composite Nephropathy Endpoint [Time frame: Up to approximately 35 months]
Change in eGFR Slope (Total) [Time frame: Baseline up to approximately 35 months]
Change in eGFR Slope (Chronic) [Time frame: From 4 months up to approximately 35 months]
Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes [Time frame: Up to approximately 35 months]
Time to the First HF Event [Time frame: Up to approximately 35 months]
Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time frame: Baseline and Week 72]
Change from Baseline in Body Mass Index (BMI) (kg/m^2) [Time frame: Baseline and Week 72]
Change from Baseline in the Waist Circumference (cm) [Time frame: Baseline and Week 72]

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 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):

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.
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:

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.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment