Trials Today

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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Age ≥ 18 years at the time of informed consent. - BMI ≥ 30.0 kg/m^2 at the time of 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 from the beginning of screening. - Elevated NT-proBNP. - Participants must have at least one of the following: 1. Structural heart disease within 12 months prior to screening OR 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 3. Evidence of elevated filling pressures 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 myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease. - Any lifetime history of LVEF ≤ 40%. - 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. - 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 Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Maridebart Cafraglutide	Participants will receive maridebart cafraglutide subcutaneously (SC)	Drug: Maridebart cafraglutide Maridebart cafraglutide will be administered SC. Other names: AMG 133 MariTide
Placebo Comparator Placebo	Participants will receive placebo SC	Drug: Placebo Placebo will be administered SC.

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35205

SEC Clinical Research
Dothan 4059102, Alabama 4829764 36305

Eastern Shore Research Institute
Fairhope 4061234, Alabama 4829764 36532

Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801-4317

HonorHealth
Phoenix 5308655, Arizona 5551752 85006

Medical Advancement Centers of Arizona
Phoenix 5308655, Arizona 5551752 85044

Pima Heart and Vascular Clinical Research
Tucson 5318313, Arizona 5551752 85704

Yuma Clinical Trials
Yuma 5322053, Arizona 5551752 85365

Arkansas Cardiology
Little Rock 4119403, Arkansas 4099753 72205

National Heart Institute
Beverly Hills 5328041, California 5332921 90211

Valley Clinical Trials, LLC dba Flourish Research
Covina 5340175, California 5332921 91723

National Institute of Clinical Research
Huntington Beach 5358705, California 5332921 92648

310 Clinical Research
Inglewood 5359488, California 5332921 90301

Radin Cardiovascular Medical Group
Newport Beach 5376890, California 5332921 92663

Valley Clinical Trials
Northridge 5377985, California 5332921 91325

University of California Irvine
Orange 5379513, California 5332921 92868

Empire Clinical Research
Pomona 5384170, California 5332921 91767

San Diego Cardiac Center
San Diego 5391811, California 5332921 92123

NorthBay Clinical Research LLC
Santa Rosa 5393287, California 5332921 95405

Manshadi Heart Institute
Stockton 5399020, California 5332921 95204

Cardiology Associates of Fairfield County PC
Stamford 4843564, Connecticut 4831725 06905

Orlando Heart and Vascular Institute
Altamonte Springs 4145941, Florida 4155751 32714

Excel Medical Clinical Trials
Boca Raton 4148411, Florida 4155751 33434

Cardiovascular and Vein Center of Florida
Bradenton 4148708, Florida 4155751 34209

Millennium Medical Research
Coral Gables 4151871, Florida 4155751 33134

Elite Cardiac Research Center LLC
Hialeah 4158476, Florida 4155751 33013

Encore Medical Research LLC
Hollywood 4158928, Florida 4155751 33024

Nature Coast Clinical Research
Inverness 4159786, Florida 4155751 34452

East Coast Institute for Research
Jacksonville 4160021, Florida 4155751 32216

First Coast Cardiovascular Institute PA
Jacksonville 4160021, Florida 4155751 32216

Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751 32216

Clearwater Cardiovascular Consultants
Largo 4161580, Florida 4155751 33777

Ocala Cardiovascular Research
Ocala 4166673, Florida 4155751 34471

Orlando Health Heart Institute
Orlando 4167147, Florida 4155751 32806

Ormond Beach Clinical Research
Ormond Beach 4167178, Florida 4155751 32174

Broward Research Center
Pembroke Pines 4168139, Florida 4155751 33024

Ascension Sacred Heart
Pensacola 4168228, Florida 4155751 32504

Cardiovascular Center of Sarasota
Sarasota 4172131, Florida 4155751 34239

Cardiology Partners Clinical Research Institute
Wellington 4177703, Florida 4155751 33449

Guardian Research Organization LLC
Winter Park 4178560, Florida 4155751 32792

Privia Medical Group Georgia LLC
Peachtree City 4215110, Georgia 4197000 30269

High Desert Heart and Vascular
Meridian 5600685, Idaho 5596512 83642

Chicago Medical Research LLC
Hazel Crest 4895416, Illinois 4896861 60429

Midwest Cardiovascular Research And Education Foundation
Elkhart 4919987, Indiana 4921868 46514

Ascension Medical Group
Indianapolis 4259418, Indiana 4921868 46260

Cardiovascular Research of Northwest Indiana LLC
Munster 4924014, Indiana 4921868 46321

Reid Physician Associates
Richmond 4263681, Indiana 4921868 47374

Johnson County Clintrials
Lenexa 4274356, Kansas 4273857 66219

Kansas Nephrology Research Institute LLC
Wichita 4281730, Kansas 4273857 67214

The Research Group of Lexington LLC
Lexington 4297983, Kentucky 6254925 40503

Louisiana Heart Center - Hammond
Covington 4321005, Louisiana 4331987 70433

Heart Clinic of Hammond
Hammond 4326868, Louisiana 4331987 70403

Northshore Heart and Vascular LLC
Mandeville 4332455, Louisiana 4331987 70448

Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287

Metropolitan Cardiovascular Consultants LLC
Beltsville 4348353, Maryland 4361885 20705

Flourish Bowie
Bowie 4349159, Maryland 4361885 20715

Healthy Heart Cardiology
Grand Rapids 4994358, Michigan 5001836 49546

Advanced Cardiology Associates
Rochester Hills 5007402, Michigan 5001836 48307

Fairview Health Services M Health Fairview St Johns Hospital
Maplewood 5036588, Minnesota 5037779 55109

Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111

Kalispell Regional Medical Center
Kalispell 5660340, Montana 5667009 59901

Bryan Heart
Lincoln 5072006, Nebraska 5073708 68506

Methodist Physicians Clinic Heart Consultants
Omaha 5074472, Nebraska 5073708 68114

Advanced Heart Care LLC
Bridgewater 8299576, New Jersey 5101760 08807

Virtua Health Incorporated
Marlton 4502911, New Jersey 5101760 08053

CardioMetabolic Collaborative Clinic
Somerset 5104755, New Jersey 5101760 08873

Capital Cardiology Associates
Albany 5106834, New York 5128638 12211

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10019

Hudson Valley Cardiovascular Practice PC
Poughkeepsie 5132143, New York 5128638 12601

Richmond University Medical Center
Staten Island 5139568, New York 5128638 10310

Duke University Health System
Durham 4464368, North Carolina 4482348 27719

Accellacare of Wilmington
Wilmington 4499379, North Carolina 4482348 28401

South Oklahoma Heart Research
Oklahoma City 4544349, Oklahoma 4544379 73135

Abington Medical Specialists
Horsham 5194302, Pennsylvania 6254927 19044

Monument Health Clinical Research
Rapid City 5768233, South Dakota 5769223 57701

Apex Research Foundation, LLC
Jackson 4632595, Tennessee 4662168 38301

The Jackson Clinic PA
Jackson 4632595, Tennessee 4662168 38305

Parkway Cardiology Associates
Oak Ridge 4646571, Tennessee 4662168 37830

Cardiovascular Research of Knoxville North Knoxville Medical Center
Powell 4651138, Tennessee 4662168 37849

Tennessee Center for Clinical Trials
Tullahoma 4663494, Tennessee 4662168 37388

PharmaTex Research, LLC
Amarillo 5516233, Texas 4736286 79106

Javara Research
Conroe 4682991, Texas 4736286 77384

Dallas Heart and Vascular Consultants
Duncanville 4687331, Texas 4736286 75137

David Turbay, MD
El Paso 5520993, Texas 4736286 79905

East Texas Cardiology PA
Houston 4699066, Texas 4736286 77002

Biopharma Informatic
Houston 4699066, Texas 4736286 77025

Biopharma Informatic, LLC
Houston 4699066, Texas 4736286 77043

Biopharma Informatic
Houston 4699066, Texas 4736286 77084

Vital Heart and Vein
Humble 4699442, Texas 4736286 77338

North Dallas Research Associates
McKinney 4710178, Texas 4736286 75069

Texas Institute of Cardiology
McKinney 4710178, Texas 4736286 75071

Sherman Clinical Research
Sherman 4728328, Texas 4736286 75092

Northwest Houston Clinical Research PLLC
Tomball 4737094, Texas 4736286 77375

Carient Heart and Vascular
Manassas 4771401, Virginia 6254928 20109

Roanoke Heart Institute PLC
Roanoke 4782167, Virginia 6254928 24014

Salem VA Medical Center
Salem 4784112, Virginia 6254928 24153

Pulse Heart Institute
Puyallup 5807575, Washington 5815135 98372

More Details

NCT ID: NCT07037459
Status: Recruiting
Sponsor: Amgen

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.