Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesity
Investigational drug(s) / intervention(s)
Maridebart cafraglutidePlacebo
Maridebart cafraglutide: Maridebart cafraglutide will be administered SC.
Placebo: Placebo will be administered SC.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
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.
Primary outcome measure(s)
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events — Up to approximately 35 months Heart Failure events include: hospitalization for HF or urgent HF visits.
Trial sites (657)
Facility
City
Region
Status
University of Alabama Saint Vincent's Birmingham
Birmingham
Alabama
Recruiting
SEC Clinical Research
Dothan
Alabama
Recruiting
Eastern Shore Research Institute
Fairhope
Alabama
Recruiting
Heart Center Research LLC
Huntsville
Alabama
Recruiting
HonorHealth
Phoenix
Arizona
Recruiting
Medical Advancement Centers of Arizona
Phoenix
Arizona
Recruiting
Pima Heart and Vascular Clinical Research
Tucson
Arizona
Recruiting
Yuma Clinical Trials
Yuma
Arizona
Recruiting
Arkansas Cardiology
Little Rock
Arkansas
Recruiting
National Heart Institute
Beverly Hills
California
Recruiting
Valley Clinical Trials, LLC dba Flourish Research
Covina
California
Recruiting
National Institute of Clinical Research
Huntington Beach
California
Recruiting
310 Clinical Research
Inglewood
California
Recruiting
Radin Cardiovascular Medical Group
Newport Beach
California
Recruiting
Valley Clinical Trials
Northridge
California
Recruiting
University of California Irvine
Orange
California
Recruiting
Empire Clinical Research
Pomona
California
Recruiting
San Diego Cardiac Center
San Diego
California
Recruiting
Kaiser Permanente
San Francisco
California
Recruiting
NorthBay Clinical Research LLC
Santa Rosa
California
Recruiting
Manshadi Heart Institute
Stockton
California
Recruiting
Cardiology Associates of Fairfield County PC
Stamford
Connecticut
Recruiting
Orlando Heart and Vascular Institute
Altamonte Springs
Florida
Recruiting
D and H Tamarac Research Center
Aventura
Florida
Recruiting
Excel Medical Clinical Trials
Boca Raton
Florida
Recruiting
Cardiovascular and Vein Center of Florida
Bradenton
Florida
Recruiting
Millennium Medical Research
Coral Gables
Florida
Recruiting
Elite Cardiac Research Center LLC
Hialeah
Florida
Recruiting
Encore Medical Research LLC
Hollywood
Florida
Recruiting
Nature Coast Clinical Research
Inverness
Florida
Recruiting
East Coast Institute for Research
Jacksonville
Florida
Recruiting
First Coast Cardiovascular Institute PA
Jacksonville
Florida
Recruiting
Jacksonville Center for Clinical Research
Jacksonville
Florida
Recruiting
Clearwater Cardiovascular Consultants
Largo
Florida
Recruiting
Ocala Cardiovascular Research
Ocala
Florida
Recruiting
AdventHealth Orlando
Orlando
Florida
Recruiting
Orlando Health Heart Institute
Orlando
Florida
Recruiting
Ormond Beach Clinical Research
Ormond Beach
Florida
Recruiting
Broward Research Center
Pembroke Pines
Florida
Recruiting
Ascension Sacred Heart
Pensacola
Florida
Recruiting
+ 617 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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