RECRUITING

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

Talk to us

Conditions

Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesityHeart FailureMaridebart CafraglutideAMG 133MariTide

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-06-25
Study Completion:2030-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07037459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years at the time of informed consent.
  2. * BMI ≥ 30.0 kg/m\^2 at the time of randomization.
  3. * HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
  4. * Managed with HF standard of care therapies.
  5. * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months from the beginning of screening.
  6. * Elevated NT-proBNP.
  7. * Participants must have at least one of the following:
  8. 1. Structural heart disease within 12 months prior to screening OR
  9. 2. Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment \> 30 days and \< 12 months prior to randomization OR
  10. 3. Evidence of elevated filling pressures within 12 months before randomization.
  1. * 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.
  2. * HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
  3. * Any lifetime history of LVEF ≤ 40%.
  4. * Hospitalized with acute decompensated HF at the time of or during the screening period.
  5. * Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
  6. * For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
  7. 1. HbA1c \> 10.0% (86 mmol/mol) at screening
  8. 2. Uncontrolled diabetes requiring immediate therapy
  9. 3. History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization
  10. 4. One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
  11. 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.
  12. * 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.
  13. * History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
  14. * Any personal lifetime history of, or family history(first-degree relative\[s\]) of medullary thyroid carcinoma or MEN-2.
  15. * eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
  16. * Calcitonin ≥ 50 ng/L (pg/mL) at screening.
  17. * Acute or chronic hepatitis.
  18. * Any of the following psychiatric history:
  19. 1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
  20. 2. Lifetime history of suicide attempt
  21. 3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
  22. * History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
  23. * 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.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
SEC Clinical Research
Dothan, Alabama, 36305
United States
Eastern Shore Research Institute
Fairhope, Alabama, 36532
United States
Heart Center Research LLC
Huntsville, Alabama, 35801-4317
United States
HonorHealth
Phoenix, Arizona, 85006
United States
Medical Advancement Centers of Arizona
Phoenix, Arizona, 85044
United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, 85704
United States
Yuma Clinical Trials
Yuma, Arizona, 85365
United States
Arkansas Cardiology
Little Rock, Arkansas, 72205
United States
National Heart Institute
Beverly Hills, California, 90211
United States
Valley Clinical Trials, LLC dba Flourish Research
Covina, California, 91723
United States
National Institute of Clinical Research
Huntington Beach, California, 92648
United States
310 Clinical Research
Inglewood, California, 90301
United States
Radin Cardiovascular Medical Group
Newport Beach, California, 92663
United States
Valley Clinical Trials
Northridge, California, 91325
United States
University of California Irvine
Orange, California, 92868
United States
Empire Clinical Research
Pomona, California, 91767
United States
San Diego Cardiac Center
San Diego, California, 92123
United States
NorthBay Clinical Research LLC
Santa Rosa, California, 95405
United States
Manshadi Heart Institute
Stockton, California, 95204
United States
Cardiology Associates of Fairfield County PC
Stamford, Connecticut, 06905
United States
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, 32714
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Cardiovascular and Vein Center of Florida
Bradenton, Florida, 34209
United States
Millennium Medical Research
Coral Gables, Florida, 33134
United States
Elite Cardiac Research Center LLC
Hialeah, Florida, 33013
United States
Encore Medical Research LLC
Hollywood, Florida, 33024
United States
Nature Coast Clinical Research
Inverness, Florida, 34452
United States
East Coast Institute for Research
Jacksonville, Florida, 32216
United States
First Coast Cardiovascular Institute PA
Jacksonville, Florida, 32216
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Clearwater Cardiovascular Consultants
Largo, Florida, 33777
United States
Ocala Cardiovascular Research
Ocala, Florida, 34471
United States
Orlando Health Heart Institute
Orlando, Florida, 32806
United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174
United States
Broward Research Center
Pembroke Pines, Florida, 33024
United States
Ascension Sacred Heart
Pensacola, Florida, 32504
United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
United States
Guardian Research Organization LLC
Winter Park, Florida, 32792
United States
Privia Medical Group Georgia LLC
Peachtree City, Georgia, 30269
United States
High Desert Heart and Vascular
Meridian, Idaho, 83642
United States
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429
United States
Saint Vincent Medical Group Incorporated dba Ascension Medical Group Saint Vincent
Indianapolis, Indiana, 46260
United States
Cardiovascular Research of Northwest Indiana LLC
Munster, Indiana, 46321
United States
Reid Physician Associates
Richmond, Indiana, 47374
United States
Johnson County Clintrials
Lenexa, Kansas, 66219
United States
Kansas Nephrology Research Institute LLC
Wichita, Kansas, 67214
United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
United States
Louisiana Heart Center - Hammond
Covington, Louisiana, 70433
United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403
United States
Northshore Heart and Vascular LLC
Mandeville, Louisiana, 70448
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Metropolitan Cardiovascular Consultants LLC
Beltsville, Maryland, 20705
United States
Flourish Bowie
Bowie, Maryland, 20715
United States
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546
United States
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307
United States
Fairview Health Services M Health Fairview St Johns Hospital
Maplewood, Minnesota, 55109
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901
United States
Bryan Heart
Lincoln, Nebraska, 68506
United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, 68114
United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807
United States
CardioMetabolic Collaborative Clinic
Somerset, New Jersey, 08873
United States
Capital Cardiology Associates
Albany, New York, 12211
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10019
United States
Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York, 12601
United States
Richmond University Medical Center
Staten Island, New York, 10310
United States
Duke University Health System
Durham, North Carolina, 27719
United States
Accellacare of Wilmington
Wilmington, North Carolina, 28401
United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
United States
Abington Medical Specialists
Horsham, Pennsylvania, 19044
United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701
United States
Apex Research Foundation, LLC
Jackson, Tennessee, 38301
United States
The Jackson Clinic PA
Jackson, Tennessee, 38305
United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830
United States
Cardiovascular Research of Knoxville North Knoxville Medical Center
Powell, Tennessee, 37849
United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
United States
PharmaTex Research, LLC
Amarillo, Texas, 79106
United States
Javara Research
Conroe, Texas, 77384
United States
Dallas Heart and Vascular Consultants
Duncanville, Texas, 75137
United States
David Turbay, MD
El Paso, Texas, 79905
United States
East Texas Cardiology PA
Houston, Texas, 77002
United States
Biopharma Informatic
Houston, Texas, 77025
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Biopharma Informatic
Houston, Texas, 77084
United States
Vital Heart and Vein
Humble, Texas, 77338
United States
North Dallas Research Associates
McKinney, Texas, 75069
United States
Texas Institute of Cardiology
McKinney, Texas, 75071
United States
Sherman Clinical Research
Sherman, Texas, 75092
United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375
United States
Carient Heart and Vascular
Manassas, Virginia, 20109
United States
Roanoke Heart Institute PLC
Roanoke, Virginia, 24014
United States
Salem VA Medical Center
Salem, Virginia, 24153
United States
Pulse Heart Institute
Puyallup, Washington, 98372
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2030-09-29

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2030-09-29

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • Obesity
  • Maridebart Cafraglutide
  • AMG 133
  • MariTide

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Mildly Reduced Ejection Fraction
  • Obesity