DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Status
Recruiting
Phase
Phase 3
Enrollment
5,056
Locations
628
Results
Not posted
Publications
0
Study summary
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 will be administered SC.
DRUG
Placebo will be administered SC.
Timeline
First posted
Jun 25, 2025
Study start
Jun 25, 2025
Primary completion
Jun 30, 2028
Study completion
Sep 29, 2030
Results posted
Not reported
Registry updated
Jul 2, 2026
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.
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
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
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
No PMID-linked publications were present in this registry snapshot.
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