Current partner codePEPTIDESDE
NCT07037459·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

5,056

Locations

628

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Maridebart cafraglutide

Maridebart cafraglutide will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

Timeline

From registration to results.

  1. First posted

    Jun 25, 2025

  2. Study start

    Jun 25, 2025

  3. Primary completion

    Jun 30, 2028

  4. Study completion

    Sep 29, 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2026

Outcomes

What the study measures.

Primary outcomes

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events

Time frame · Up to approximately 35 months

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

Secondary outcomes

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

The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.

Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame · Baseline and Week 48

The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.

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

The composite nephropathy endpoint consists of: persistent macroalbuminuria, persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

628 registered sites.

Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · Chile · China · Colombia · Czechia · Denmark · Finland · France · Germany · Greece · Hong Kong · Hungary · Italy · Japan · Mexico · Netherlands · Poland · Portugal · Romania · Slovakia · South Korea · Spain · Sweden · Switzerland · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

University of Alabama Saint Vincent's Birmingham

Birmingham, Alabama, United States

SEC Clinical Research

Dothan, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, United States

Heart Center Research LLC

Huntsville, Alabama, United States

HonorHealth

Phoenix, Arizona, United States

Medical Advancement Centers of Arizona

Phoenix, Arizona, United States

Pima Heart and Vascular Clinical Research

Tucson, Arizona, United States

Yuma Clinical Trials

Yuma, Arizona, United States

Arkansas Cardiology

Little Rock, Arkansas, United States

National Heart Institute

Beverly Hills, California, United States

Valley Clinical Trials, LLC dba Flourish Research

Covina, California, United States

National Institute of Clinical Research

Huntington Beach, California, United States

310 Clinical Research

Inglewood, California, United States

Radin Cardiovascular Medical Group

Newport Beach, California, United States

Valley Clinical Trials

Northridge, California, United States

University of California Irvine

Orange, California, United States

Empire Clinical Research

Pomona, California, United States

San Diego Cardiac Center

San Diego, California, United States

NorthBay Clinical Research LLC

Santa Rosa, California, United States

Manshadi Heart Institute

Stockton, California, United States

Cardiology Associates of Fairfield County PC

Stamford, Connecticut, United States

Orlando Heart and Vascular Institute

Altamonte Springs, Florida, United States

D and H Tamarac Research Center

Aventura, Florida, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

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Put the record in context.

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