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)

Status: Recruiting
Location: See all (113) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study 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 study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• BMI ≥ 30 kg/m\^2.

• HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.

• Managed with HF standard of care therapies.

• Left ventricular ejection fraction (LVEF) of \> 40%.

• Elevated NT-proBNP.

• Participants must have at least one of the following:

‣ Structural heart disease OR

⁃ Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR

⁃ Evidence of elevated filling pressures within 12 months before randomization.

Locations
United States
Alabama
SEC Clinical Research
RECRUITING
Dothan
Eastern Shore Research Institute
RECRUITING
Fairhope
Heart Center Research LLC
RECRUITING
Huntsville
Arkansas
Arkansas Cardiology
RECRUITING
Little Rock
Arizona
Medical Advancement Centers of Arizona
RECRUITING
Phoenix
Pima Heart and Vascular Clinical Research
RECRUITING
Tucson
California
National Heart Institute
RECRUITING
Beverly Hills
National Institute of Clinical Research
RECRUITING
Huntington Beach
310 Clinical Research
RECRUITING
Inglewood
Radin Cardiovascular Medical Group
RECRUITING
Newport Beach
Valley Clinical Trials
RECRUITING
Northridge
University of California Irvine
RECRUITING
Orange
Empire Clinical Research
RECRUITING
Pomona
NorthBay Clinical Research LLC
RECRUITING
Santa Rosa
Florida
Orlando Heart and Vascular Institute
RECRUITING
Altamonte Springs
Excel Medical Clinical Trials
RECRUITING
Boca Raton
Millennium Medical Research
RECRUITING
Coral Gables
Elite Cardiac Research Center LLC
RECRUITING
Hialeah
Encore Medical Research LLC
RECRUITING
Hollywood
Nature Coast Clinical Research
RECRUITING
Inverness
East Coast Institute for Research
RECRUITING
Jacksonville
First Coast Cardiovascular Institute PA
RECRUITING
Jacksonville
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Clearwater Cardiovascular Consultants
RECRUITING
Largo
Ocala Cardiovascular Research
RECRUITING
Ocala
Ormond Beach Clinical Research
RECRUITING
Ormond Beach
Broward Research Center
RECRUITING
Pembroke Pines
Cardiovascular Center of Sarasota
RECRUITING
Sarasota
Cardiology Partners Clinical Research Institute
RECRUITING
Wellington
Guardian Research Organization LLC
RECRUITING
Winter Park
Georgia
Privia Medical Group Georgia LLC
RECRUITING
Peachtree City
Idaho
High Desert Heart and Vascular
RECRUITING
Meridian
Illinois
Chicago Medical Research LLC
RECRUITING
Hazel Crest
Indiana
Cardiovascular Research of Northwest Indiana LLC
RECRUITING
Munster
Reid Physician Associates
RECRUITING
Richmond
Kansas
Johnson County Clintrials
RECRUITING
Lenexa
Kentucky
The Research Group of Lexington LLC
RECRUITING
Lexington
Louisiana
Louisiana Heart Center - Hammond
RECRUITING
Covington
Heart Clinic of Hammond
RECRUITING
Hammond
Northshore Heart and Vascular LLC
RECRUITING
Mandeville
Maryland
Metropolitan Cardiovascular Consultants LLC
RECRUITING
Beltsville
Flourish Bowie
RECRUITING
Bowie
Michigan
Healthy Heart Cardiology
RECRUITING
Grand Rapids
Advanced Cardiology Associates
RECRUITING
Rochester Hills
Minnesota
Fairview Health Services M Health Fairview St Johns Hospital
RECRUITING
Maplewood
Montana
Kalispell Regional Medical Center
RECRUITING
Kalispell
Nebraska
Methodist Physicians Clinic Heart Consultants
RECRUITING
Omaha
New Jersey
CardioMetabolic Collaborative Clinic
RECRUITING
Somerset
New York
Capital Cardiology Associates
RECRUITING
Albany
Richmond University Medical Center
RECRUITING
Staten Island
Oklahoma
South Oklahoma Heart Research
RECRUITING
Oklahoma City
Pennsylvania
Abington Medical Specialists
RECRUITING
Horsham
South Dakota
Monument Health Clinical Research
RECRUITING
Rapid City
Tennessee
Apex Research Foundation, LLC
RECRUITING
Jackson
Parkway Cardiology Associates
RECRUITING
Oak Ridge
Cardiovascular Research of Knoxville North Knoxville Medical Center
RECRUITING
Powell
Tennessee Center for Clinical Trials
RECRUITING
Tullahoma
Texas
PharmaTex Research, LLC
RECRUITING
Amarillo
Javara Research
RECRUITING
Conroe
Dallas Heart and Vascular Consultants
RECRUITING
Duncanville
David Turbay, MD
RECRUITING
El Paso
Biopharma Informatic
RECRUITING
Houston
Biopharma Informatic
RECRUITING
Houston
Biopharma Informatic, LLC
RECRUITING
Houston
East Texas Cardiology PA
RECRUITING
Houston
Vital Heart and Vein
RECRUITING
Humble
North Dallas Research Associates
RECRUITING
Mckinney
Texas Institute of Cardiology
RECRUITING
Mckinney
Sherman Clinical Research
RECRUITING
Sherman
Northwest Houston Clinical Research PLLC
RECRUITING
Tomball
Virginia
Carient Heart and Vascular
RECRUITING
Manassas
Roanoke Heart Institute PLC
RECRUITING
Roanoke
Other Locations
Australia
Advara HeartCare Wesley
RECRUITING
Auchenflower
Flinders Medical Centre
RECRUITING
Bedford Park
Advara HeartCare Leabrook
RECRUITING
Leabrook
Sydney Cardiometabolic Centre
RECRUITING
Liverpool
Core Research Group Pty Ltd
RECRUITING
Milton
Advara HeartCare Mulgrave
RECRUITING
Mulgrave
Royal North Shore Hospital
RECRUITING
St Leonards
Dr Heart Pty Ltd
RECRUITING
Woolloongabba
Canada
Brampton Clinical Trials
RECRUITING
Brampton
Saul Vizel Professional Medicine Corporation - Vizel Cardiac Research
RECRUITING
Cambridge
Ecogene-21
RECRUITING
Chicoutimi
Partners in Advanced Cardiac Evaluation
RECRUITING
Newmarket
North York Diagnostic and Cardiac Centre
RECRUITING
North York
Kawartha Cardiology Clinical Trials
RECRUITING
Peterborough
CardioQuest Research Centre
RECRUITING
Sarnia
Heart Health Institute Research Incorporated
RECRUITING
Scarborough Village
Diex Recherche Sherbrooke Incorporated
RECRUITING
Sherbrooke
KMH Cardiology Centres Incorporated Hamilton
RECRUITING
Stoney Creek
Curans Heart Center
RECRUITING
Thunder Bay
Diabetes Heart Research Centre
RECRUITING
Toronto
Diex Recherche Trois Rivieres
RECRUITING
Trois-rivières
Winchester District Memorial Hospital
RECRUITING
Winchester
Cardio 1
RECRUITING
Winnipeg
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Japan
Fujinomiya City General Hospital
RECRUITING
Fujinomiya-shi
Medical Corporation Kenshinkai Minamino Cardiovascular Hospital
RECRUITING
Hachioji-shi
Japanese Red Cross Hamamatsu Hospital
RECRUITING
Hamamatsu
Affiliated Central Clinic of Higashiyamato Hospital
RECRUITING
Higashiyamato-shi
Tenyoukai Central Clinic
RECRUITING
Kagoshima
Kumamoto Kinoh Hospital
RECRUITING
Kumamoto
Rakuwakai Otowa Hospital
RECRUITING
Kyoto
Oita Red Cross Hospital
RECRUITING
Ōita
Sagamihara Kyodo Hospital
RECRUITING
Sagamihara-shi
Miyanosawa Clinic of Internal Medicine and Cardiology
RECRUITING
Sapporo
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
RECRUITING
Shinagawa-ku
NewHeart Watanabe Institute
RECRUITING
Suginami-ku
Takamatsu Red Cross Hospital
RECRUITING
Takamatsu
Sanin Rosai Hospital
RECRUITING
Yonago-shi
Republic of Korea
Yonsei University Wonju Severance Christian Hospital
RECRUITING
Wonju-si, Gangwon-do
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2030-09-29
Participants
Target number of participants: 5056
Treatments
Experimental: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC)
Placebo_comparator: Placebo
Participants will receive placebo SC
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov