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Purpose

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 45 years at screening. - BMI of ≥ 27.0 kg/m^2 at screening. - History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following: - Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). - Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation). - Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) < 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.

Exclusion Criteria

  • History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA). - New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization. - Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification. - For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening): - HbA1c > 10.0% (86 mmol/mol) at screening. - 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 of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema. - 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 before randomization or planned use during the conduct of the trial. - History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization. - Family (first-degree relative[s]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2). - Calcitonin ≥ 50 ng/L (pg/mL) at screening. - Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) > 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL). - History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ). - Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.

Study Design

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

Arm Groups

ArmDescriptionAssigned 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

Alliance For Multispecialty Research - Daphne
Daphne, Alabama 36526

Eastern Shore Research Institute
Fairhope, Alabama 36532

Heart Center Research LLC
Huntsville, Alabama 35801

Mobile Heart Specialists PC
Mobile, Alabama 36608

Syed Research Consultants LLC
Sheffield, Alabama 35660

Synexus Clinical Research US, Inc.
Phoenix, Arizona 85020

Medical Advancement Centers of Arizona
Phoenix, Arizona 85044

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

Velocity Clinical Research- Huntington Park
Huntington Park, California 90255

Orange County Research Center
Lake Forest, California 92630

Biopharma Informatic - The Cardiovascular Center
Redding, California 96001

Acclaim Clinical Research
San Diego, California 92120

Encompass Clinical Research
Spring Valley, California 91978

Diablo Clinical Research
Walnut Creek, California 94598

Focus Clinical Research
West Hills, California 91307

Family Practice Associates
Wilmington, Delaware 19805

Excel Medical Clinical Trials
Boca Raton, Florida 33434

Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida 32132

Alliance for Multispecialty Research - Fort Myers
Fort Myers, Florida 33912

Elite Cardiac Research Center LLC
Hialeah, Florida 33013

Elite Clinical Research
Hialeah, Florida 33018

Zenith Clinical Research
Hollywood, Florida 33021

Encore Medical Research LLC
Hollywood, Florida 33024

East Coast Institute for Research, LLC
Jacksonville, Florida 32216

Clinical Research of Central Florida
Lakeland, Florida 33805

South Florida Clinical Research
Margate, Florida 33063

Finlay Medical Research
Miami, Florida 33126

Suncoast Research Group LLC
Miami, Florida 33135

New Horizon Research Center
Miami, Florida 33165

Panax Clinical Research
Miami Lakes, Florida 33014

San Marcus Research Clinic Inc
Miami Lakes, Florida 33014

Indago Research and Health Center
Miami Lakes, Florida 33016

West Orange Endocrinology
Ocoee, Florida 34761

Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida 33410

Peace River Cardiovascular Center
Port Charlotte, Florida 33952

Progressive Medical Research
Port Orange, Florida 32127

Saint Johns Center for Clinical Research
Saint Augustine, Florida 32086

Intercoastal Medical Group
Sarasota, Florida 34239

Winter Haven Hospital
Winter Haven, Florida 33881

East Coast Institute for Research LLC at Canton Georgia
Canton, Georgia 30114

The Jones Center Clinical Research
Macon, Georgia 31210

Velocity Clinical Research - Savannah
Savannah, Georgia 31419

Velocity Clinical Research - Boise
Meridian, Idaho 83642

Endeavor Health-Northwest Community Healthcare
Arlington Heights, Illinois 60005

Eagle Clinical Research
Chicago, Illinois 60621

University of Chicago
Chicago, Illinois 60637

Alliance For Multispecialty Research - Oak Brook
Oak Brook, Illinois 60523

Prarie Education and Research
Springfield, Illinois 62701

Cardiovascular Research of Northwest Indiana LLC
Munster, Indiana 46321

Velocity Clinical Research - Valparaiso
Valparaiso, Indiana 46383

McFarland Clinic PC
Ames, Iowa 50010

Midwest Cardiovascular Research Foundation
Davenport, Iowa 52801

Cotton-ONeil Diabetes and Endocrinology Center
Topeka, Kansas 66606

Cardiovascular Associates Research, LLC
Covington, Louisiana 70433

Tandem Clinical Research - Marrero
Marrero, Louisiana 70072

Ascension Saint Agnes Heart Care
Baltimore, Maryland 21229

MD Medical Research
Oxon Hill, Maryland 20745

Velocity Clinical Research - Rockville
Rockville, Maryland 20854

Brigham and Womens Hospital
Boston, Massachusetts 02115

Btc of New Bedford
New Bedford, Massachusetts 02740

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

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407

Jackson Heart Clinic
Jackson, Mississippi 39216

Cardiology Associates of North Mississippi
Tupelo, Mississippi 38801

StudyMetrix Research
City of Saint Peters, Missouri 63303

Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri 64114

Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128

Saint Louis Heart and Vascular PC
St Louis, Missouri 63136

Bryan Heart
Lincoln, Nebraska 68506

University of Nebraska Medical Center
Omaha, Nebraska 68198

Primary Clinical Research
Papillion, Nebraska 68046

Excel Clinical Research
Las Vegas, Nevada 89109

Vector Clinical Trials
Las Vegas, Nevada 89128

CardioMetabolic Collaborative Clinic
Somerset, New Jersey 08873

Velocity Clinical Research - Binghamton
Binghamton, New York 13905

Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York 12601

Rochester Clinical Research
Rochester, New York 14609

Saratoga Clinical Research, LLC
Saratoga Springs, New York 12866

Southgate Medical Group
West Seneca, New York 14224

Novant Health Heart and Vascular Institute
Charlotte, North Carolina 28204

Velocity Clinical Research - Durham
Durham, North Carolina 27701

Moses H Cone Memorial Hospital
Greensboro, North Carolina 27401

Monroe Biomedical Research
Monroe, North Carolina 28112

West Clinical Research
Morehead City, North Carolina 28557

Burke Primary Care Family Practice
Morganton, North Carolina 28655

Accellacare of Raleigh
Raleigh, North Carolina 27609

Accellacare of Piedmont Healthcare
Statesville, North Carolina 28625

Brookview Hills Research Associates Llc
Winston-Salem, North Carolina 27103

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157

Velocity Clinical Research - Cleveland
Beachwood, Ohio 44122

Aultman Hospital, Cardiovascular Consultants, Inc
Canton, Ohio 44710

Velocity Clinical Research - Auburn
Cincinnati, Ohio 45219

Endocrinology Associates Inc
Columbus, Ohio 43201

Nexgen Research
Lima, Ohio 45801

Heritage Valley Multispecialty Group Inc
Beaver, Pennsylvania 15009

Capital Area Research LLC
Camp Hill, Pennsylvania 17011

Abington Medical Specialists
Horsham, Pennsylvania 19044

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Accellacare Charleston
Mt. Pleasant, South Carolina 29464

Monument Health Clinical Research
Rapid City, South Dakota 57701

Stern Cardiovascular Foundation Inc
Germantown, Tennessee 38138

Accellacare of Knoxville
Knoxville, Tennessee 37912

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

Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388

PharmaTex Research, LLC
Amarillo, Texas 79106

Austin Heart
Austin, Texas 78705

Velocity Clinical Research - Austin
Austin, Texas 78759

Thyroid Endocrinology and Diabetes
Dallas, Texas 75208

Soltero Cardiovascular Research Center
Dallas, Texas 75226

Zenos Clinical Research
Dallas, Texas 75230

Cedar Health Research, LLC
Dallas, Texas 75251

University of Texas Southwestern Medical Center
Dallas, Texas 75390

David Turbay, MD
El Paso, Texas 79905

Academy of Diabetes Thyroid and Endocrine
El Paso, Texas 79935

Biopharma Informatic, LLC
Houston, Texas 77043

Cardiovascular Specialists of Willowbrook
Houston, Texas 77070

PlanIt Research, PLLC
Houston, Texas 77079

Research Physicians Network, LLC
Houston, Texas 77089

Vital Heart and Vein
Humble, Texas 77338

Tcr Institute Llc
Kingwood, Texas 77339

Helium Research Group
Lake Jackson, Texas 77566

Epic Clinical Research
Lewisville, Texas 75057

Biopharma Informatic-McAllen
McAllen, Texas 78503

Southern Endocrinology Associates PA
Mesquite, Texas 75149

North Hills Medical Research
North Richland Hills, Texas 76180

Bandera Family Health Care
San Antonio, Texas 78249

Consano Clinical Research - Shavano Park
Shavano Park, Texas 78231

Sugar Lakes Family Practice
Sugar Land, Texas 77479

Wichita Falls Heart Clinic
Wichita Falls, Texas 76301

Boeson Research
Provo, Utah 84604

Velocity Clinical Research - Salt Lake City
West Jordan, Utah 84088

Inova Cardiology - Fairfax
Fairfax, Virginia 22031

Virginia Heart
Falls Church, Virginia 22042

VA Puget Sound Healthcare System
Seattle, Washington 98108

Velocity Clinical Research - Spokane
Spokane, Washington 99218

Vaught Neurological Services
Crab Orchard, West Virginia 25827

Aspirus Cardiovascular Associates
Wausau, Wisconsin 54401

Research and Cardiovascular
Ponce, Puerto Rico 00717

More Details

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.