Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Recruiting · NCT07037459 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
Maridebart cafraglutidePlacebo
What this trial 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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 30 US states.
- University of Alabama Saint Vincent's Birmingham - Birmingham, Alabama, United States
- University of Alabama Saint Vincent's Birmingham - Birmingham, Alabama, United States
- SEC Clinical Research - Dothan, Alabama, United States
- SEC Clinical Research - Dothan, Alabama, United States
- Eastern Shore Research Institute - Fairhope, Alabama, United States
- Eastern Shore Research Institute - Fairhope, Alabama, United States
- Heart Center Research LLC - Huntsville, 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
- HonorHealth - Phoenix, Arizona, United States
- Medical Advancement Centers of Arizona - Phoenix, Arizona, United States
- Pima Heart and Vascular Clinical Research - Tucson, Arizona, United States
- Pima Heart and Vascular Clinical Research - Tucson, Arizona, United States
- Yuma Clinical Trials - Yuma, Arizona, United States
- Yuma Clinical Trials - Yuma, Arizona, United States
- Arkansas Cardiology - Little Rock, Arkansas, United States
- Arkansas Cardiology - Little Rock, Arkansas, United States
- National Heart Institute - Beverly Hills, California, United States
- National Heart Institute - Beverly Hills, California, United States
- Valley Clinical Trials, LLC dba Flourish Research - Covina, California, United States
- Valley Clinical Trials, LLC dba Flourish Research - Covina, California, United States
- National Institute of Clinical Research - Huntington Beach, California, United States
- National Institute of Clinical Research - Huntington Beach, California, United States
- 310 Clinical Research - Inglewood, California, United States
- 310 Clinical Research - Inglewood, California, United States
- Radin Cardiovascular Medical Group - Newport Beach, California, United States
- Radin Cardiovascular Medical Group - Newport Beach, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Valley Clinical Trials - Northridge, California, United States
- University of California Irvine - Orange, California, United States
- University of California Irvine - Orange, California, United States
- Empire Clinical Research - Pomona, California, United States
- Empire Clinical Research - Pomona, California, United States
- San Diego Cardiac Center - San Diego, California, United States
- San Diego Cardiac Center - San Diego, California, United States
- Kaiser Permanente - San Francisco, California, United States
- Kaiser Permanente - San Francisco, California, United States
- NorthBay Clinical Research LLC - Santa Rosa, California, United States
- NorthBay Clinical Research LLC - Santa Rosa, California, United States
- Manshadi Heart Institute - Stockton, California, United States
- Manshadi Heart Institute - Stockton, California, United States
- Cardiology Associates of Fairfield County PC - Stamford, Connecticut, United States
- Cardiology Associates of Fairfield County PC - Stamford, Connecticut, United States
- Orlando Heart and Vascular Institute - Altamonte Springs, Florida, United States
- Orlando Heart and Vascular Institute - Altamonte Springs, Florida, United States
- D and H Tamarac Research Center - Aventura, Florida, United States
- D and H Tamarac Research Center - Aventura, Florida, United States
- Excel Medical Clinical Trials - Boca Raton, Florida, United States
- Excel Medical Clinical Trials - Boca Raton, Florida, United States
- Cardiovascular and Vein Center of Florida - Bradenton, Florida, United States
- Cardiovascular and Vein Center of Florida - Bradenton, Florida, United States
- Millennium Medical Research - Coral Gables, Florida, United States
- Millennium Medical Research - Coral Gables, Florida, United States
- Elite Cardiac Research Center LLC - Hialeah, Florida, United States
- Elite Cardiac Research Center LLC - Hialeah, Florida, United States
- Encore Medical Research LLC - Hollywood, Florida, United States
- Encore Medical Research LLC - Hollywood, Florida, United States
- Nature Coast Clinical Research - Inverness, Florida, United States
- Nature Coast Clinical Research - Inverness, Florida, United States
Showing 60 of 1314 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →