Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether maridebart cafraglutide, added to usual care, lowers the risk of heart and blood vessel problems and death more than a placebo (a treatment with no active drug). It is for adults age 45 or older who are overweight or have obesity and have artery disease caused by fatty buildup.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 45 or older at screening.
- Body mass index (BMI), a measure of weight compared with height, of 27 or higher.
- A past heart attack or stroke caused by fatty buildup in arteries, or artery disease in the legs with symptoms. Leg artery disease must be shown by walking pain with an ankle-to-arm blood pressure ratio below 0.9, a procedure to restore blood flow, or an amputation due to artery disease.
Who can't join
- A heart attack, stroke, mini-stroke, hospital stay for worsening chest pain, artery-opening procedure, or major heart or blood vessel surgery within 60 days before screening or before study group assignment. Also, the most severe heart failure at screening or a hospital stay for heart failure during that same period.
- Type 1 diabetes or any diabetes other than type 2 or past pregnancy-related diabetes. For people with type 2 diabetes, an A1c above 10% at screening. A1c measures average blood sugar.
- For people with type 2 diabetes: a dangerous high-blood-sugar crisis in the past 12 months, severe low blood sugar in the past 6 months, trouble noticing low blood sugar, certain serious diabetes-related eye problems, or current or planned treatment for these eye problems.
- Use of GLP-1, GIP, or amylin medicines within 90 days before study group assignment, or plans to use them during the study. These medicines affect blood sugar or appetite.
- Long-term swelling of the pancreas, or a sudden episode within 180 days before screening or before study group assignment. Also, hepatitis, signs of liver disease other than metabolic fatty liver disease, or certain high liver blood tests: ALT above 3 times normal or bilirubin above 1.8 times normal. For people with Gilbert syndrome, direct bilirubin is used.
- A personal history, or a parent, sibling, or child with a history, of medullary thyroid cancer or MEN-2, a condition that can cause tumors in hormone-making glands. Also, a calcitonin blood level of 50 ng/L or higher.
- Cancer within 5 years before screening or before study group assignment. Exceptions include certain skin cancers and very early breast, cervical, or prostate cancers treated with the aim of curing them.
- Able to become pregnant and planning pregnancy during the study, or unwilling to use the birth control methods required during treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (140)
AL
- Alliance For Multispecialty Research - Daphne · Daphne, AL 36526More trials in Daphne
- Eastern Shore Research Institute · Fairhope, AL 36532More trials in Fairhope
- Heart Center Research LLC · Huntsville, AL 35801More trials in Huntsville
- Mobile Heart Specialists PC · Mobile, AL 36608More trials in Mobile
- Syed Research Consultants LLC · Sheffield, AL 35660More trials in Sheffield
AZ
- Synexus Clinical Research US, Inc. · Phoenix, AZ 85020More trials in Phoenix
- Medical Advancement Centers of Arizona · Phoenix, AZ 85044More trials in Phoenix
CA
- Valley Clinical Trials, LLC dba Flourish Research · Covina, CA 91723More trials in Covina
- Velocity Clinical Research- Huntington Park · Huntington Park, CA 90255More trials in Huntington Park
- Velocity Clinical Research- Los Angeles · La Mesa, CA 91942More trials in La Mesa
- Orange County Research Center · Lake Forest, CA 92630More trials in Lake Forest
- Biopharma Informatic - The Cardiovascular Center · Redding, CA 96001More trials in Redding
- Acclaim Clinical Research · San Diego, CA 92120More trials in San Diego
- Encompass Clinical Research · Spring Valley, CA 91978More trials in Spring Valley
- Diablo Clinical Research · Walnut Creek, CA 94598More trials in Walnut Creek
- Focus Clinical Research · West Hills, CA 91307More trials in West Hills
DE
- Family Practice Associates · Wilmington, DE 19805More trials in Wilmington
FL
- Excel Medical Clinical Trials · Boca Raton, FL 33434More trials in Boca Raton
- Velocity Clinical Research - New Smyrna Beach · Edgewater, FL 32132More trials in Edgewater
- Alliance for Multispecialty Research - Fort Myers · Fort Myers, FL 33912More trials in Fort Myers
- Elite Cardiac Research Center LLC · Hialeah, FL 33013More trials in Hialeah
- Elite Clinical Research · Hialeah, FL 33018More trials in Hialeah
- Zenith Clinical Research · Hollywood, FL 33021More trials in Hollywood
- Encore Medical Research LLC · Hollywood, FL 33024More trials in Hollywood
- East Coast Institute for Research, LLC · Jacksonville, FL 32216More trials in Jacksonville
- Clinical Research of Central Florida · Lakeland, FL 33805More trials in Lakeland
- South Florida Clinical Research · Margate, FL 33063More trials in Margate
- Finlay Medical Research · Miami, FL 33126More trials in Miami
- Suncoast Research Group LLC · Miami, FL 33135More trials in Miami
- New Horizon Research Center · Miami, FL 33165More trials in Miami
- Panax Clinical Research · Miami Lakes, FL 33014More trials in Miami Lakes
- San Marcus Research Clinic Inc · Miami Lakes, FL 33014More trials in Miami Lakes
- Indago Research and Health Center · Miami Lakes, FL 33016More trials in Miami Lakes
- West Orange Endocrinology · Ocoee, FL 34761More trials in Ocoee
- Cardiology Partners Clinical Research Institute · Palm Beach Gardens, FL 33410More trials in Palm Beach Gardens
- Peace River Cardiovascular Center · Port Charlotte, FL 33952More trials in Port Charlotte
- Progressive Medical Research · Port Orange, FL 32127More trials in Port Orange
- Saint Johns Center for Clinical Research · Saint Augustine, FL 32086More trials in Saint Augustine
- Intercoastal Medical Group · Sarasota, FL 34239More trials in Sarasota
- Winter Haven Hospital · Winter Haven, FL 33881More trials in Winter Haven
GA
- East Coast Institute for Research LLC at Canton Georgia · Canton, GA 30114More trials in Canton
- The Jones Center Clinical Research · Macon, GA 31210More trials in Macon
- Velocity Clinical Research - Savannah · Savannah, GA 31419More trials in Savannah
IA
- McFarland Clinic PC · Ames, IA 50010More trials in Ames
- Midwest Cardiovascular Research Foundation · Davenport, IA 52801More trials in Davenport
ID
- Velocity Clinical Research - Boise · Meridian, ID 83642More trials in Meridian
IL
- Endeavor Health-Northwest Community Healthcare · Arlington Heights, IL 60005More trials in Arlington Heights
- Eagle Clinical Research · Chicago, IL 60621More trials in Chicago
- University of Chicago · Chicago, IL 60637More trials in Chicago
- Alliance For Multispecialty Research - Oak Brook · Oak Brook, IL 60523More trials in Oak Brook
- Prarie Education and Research · Springfield, IL 62701More trials in Springfield
IN
- Cardiovascular Research of Northwest Indiana LLC · Munster, IN 46321More trials in Munster
- Velocity Clinical Research - Valparaiso · Valparaiso, IN 46383More trials in Valparaiso
KS
- Cotton-ONeil Diabetes and Endocrinology Center · Topeka, KS 66606More trials in Topeka
KY
- Monroe Biomedical Research · Louisville, KY 40213More trials in Louisville
LA
- Cardiovascular Associates Research, LLC · Covington, LA 70433More trials in Covington
- Tandem Clinical Research - Marrero · Marrero, LA 70072More trials in Marrero
MA
- Brigham and Womens Hospital · Boston, MA 02115More trials in Boston
- Btc of New Bedford · New Bedford, MA 02740More trials in New Bedford
MD
- Ascension Saint Agnes Heart Care · Baltimore, MD 21229More trials in Baltimore
- MD Medical Research · Oxon Hill, MD 20745More trials in Oxon Hill
- Velocity Clinical Research - Rockville · Rockville, MD 20854More trials in Rockville
MN
- Fairview Health Services M Health Fairview St Johns Hospital · Maplewood, MN 55109More trials in Maplewood
- Minneapolis Heart Institute Foundation · Minneapolis, MN 55407More trials in Minneapolis
MO
- StudyMetrix Research · City of Saint Peters, MO 63303More trials in City of Saint Peters
- Alliance for Multispecialty Research - Kansas City · Kansas City, MO 64114More trials in Kansas City
- Kansas City Veterans Affairs Medical Center · Kansas City, MO 64128More trials in Kansas City
- Saint Louis Heart and Vascular PC · St Louis, MO 63136More trials in St Louis
MS
- Jackson Heart Clinic · Jackson, MS 39216More trials in Jackson
- Cardiology Associates of North Mississippi · Tupelo, MS 38801More trials in Tupelo
NC
- Novant Health Heart and Vascular Institute · Charlotte, NC 28204More trials in Charlotte
- Velocity Clinical Research - Durham · Durham, NC 27701More trials in Durham
- Moses H Cone Memorial Hospital · Greensboro, NC 27401More trials in Greensboro
- Monroe Biomedical Research · Monroe, NC 28112More trials in Monroe
- West Clinical Research · Morehead City, NC 28557More trials in Morehead City
- Burke Primary Care Family Practice · Morganton, NC 28655More trials in Morganton
- Accellacare of Raleigh · Raleigh, NC 27609More trials in Raleigh
- Accellacare of Piedmont Healthcare · Statesville, NC 28625More trials in Statesville
- Brookview Hills Research Associates Llc · Winston-Salem, NC 27103More trials in Winston-Salem
- Wake Forest University Health Sciences · Winston-Salem, NC 27157More trials in Winston-Salem
NE
- Bryan Heart · Lincoln, NE 68506More trials in Lincoln
- University of Nebraska Medical Center · Omaha, NE 68198More trials in Omaha
- Primary Clinical Research · Papillion, NE 68046More trials in Papillion
NJ
- CardioMetabolic Collaborative Clinic · Somerset, NJ 08873More trials in Somerset
NV
- Excel Clinical Research · Las Vegas, NV 89109More trials in Las Vegas
- Vector Clinical Trials · Las Vegas, NV 89128More trials in Las Vegas
NY
- Velocity Clinical Research - Binghamton · Binghamton, NY 13905More trials in Binghamton
- Hudson Valley Cardiovascular Practice PC · Poughkeepsie, NY 12601More trials in Poughkeepsie
- Rochester Clinical Research · Rochester, NY 14609More trials in Rochester
- Saratoga Clinical Research, LLC · Saratoga Springs, NY 12866More trials in Saratoga Springs
- Southgate Medical Group · West Seneca, NY 14224More trials in West Seneca
OH
- Velocity Clinical Research - Cleveland · Beachwood, OH 44122More trials in Beachwood
- Aultman Hospital, Cardiovascular Consultants, Inc · Canton, OH 44710More trials in Canton
- Velocity Clinical Research - Auburn · Cincinnati, OH 45219More trials in Cincinnati
- Endocrinology Associates Inc · Columbus, OH 43201More trials in Columbus
- Nexgen Research · Lima, OH 45801More trials in Lima
OK
- Alliance for Multispecialty Research - Norman · Norman, OK 73069More trials in Norman
PA
- Heritage Valley Multispecialty Group Inc · Beaver, PA 15009More trials in Beaver
- Capital Area Research LLC · Camp Hill, PA 17011More trials in Camp Hill
- Abington Medical Specialists · Horsham, PA 19044More trials in Horsham
RI
- Velocity Clinical Research - Providence · East Greenwich, RI 02818More trials in East Greenwich
SC
- Accellacare Charleston · Mt. Pleasant, SC 29464More trials in Mt. Pleasant
SD
- Monument Health Clinical Research · Rapid City, SD 57701More trials in Rapid City
TN
- Stern Cardiovascular Foundation Inc · Germantown, TN 38138More trials in Germantown
- Accellacare of Knoxville · Knoxville, TN 37912More trials in Knoxville
- Cardiovascular Research of Knoxville North Knoxville Medical Center · Powell, TN 37849More trials in Powell
- Tennessee Center for Clinical Trials · Tullahoma, TN 37388More trials in Tullahoma
TX
- PharmaTex Research, LLC · Amarillo, TX 79106More trials in Amarillo
- Austin Heart · Austin, TX 78705More trials in Austin
- Velocity Clinical Research - Austin · Austin, TX 78759More trials in Austin
- Thyroid Endocrinology and Diabetes · Dallas, TX 75208More trials in Dallas
- Soltero Cardiovascular Research Center · Dallas, TX 75226More trials in Dallas
- Zenos Clinical Research · Dallas, TX 75230More trials in Dallas
- Cedar Health Research, LLC · Dallas, TX 75251More trials in Dallas
- University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- David Turbay, MD · El Paso, TX 79905More trials in El Paso
- Academy of Diabetes Thyroid and Endocrine · El Paso, TX 79935More trials in El Paso
- Biopharma Informatic, LLC · Houston, TX 77043More trials in Houston
- Cardiovascular Specialists of Willowbrook · Houston, TX 77070More trials in Houston
- PlanIt Research, PLLC · Houston, TX 77079More trials in Houston
- Research Physicians Network, LLC · Houston, TX 77089More trials in Houston
- Vital Heart and Vein · Humble, TX 77338More trials in Humble
- Tcr Institute Llc · Kingwood, TX 77339More trials in Kingwood
- Helium Research Group · Lake Jackson, TX 77566More trials in Lake Jackson
- Epic Clinical Research · Lewisville, TX 75057More trials in Lewisville
- Biopharma Informatic-McAllen · McAllen, TX 78503More trials in McAllen
- Southern Endocrinology Associates PA · Mesquite, TX 75149More trials in Mesquite
- North Hills Medical Research · North Richland Hills, TX 76180More trials in North Richland Hills
- Bandera Family Health Care · San Antonio, TX 78249More trials in San Antonio
- Consano Clinical Research - Shavano Park · Shavano Park, TX 78231More trials in Shavano Park
- Sugar Lakes Family Practice · Sugar Land, TX 77479More trials in Sugar Land
- Wichita Falls Heart Clinic · Wichita Falls, TX 76301More trials in Wichita Falls
UT
- Boeson Research · Provo, UT 84604More trials in Provo
- Velocity Clinical Research - Salt Lake City · West Jordan, UT 84088More trials in West Jordan
VA
- Inova Cardiology - Fairfax · Fairfax, VA 22031More trials in Fairfax
- Virginia Heart · Falls Church, VA 22042More trials in Falls Church
WA
- VA Puget Sound Healthcare System · Seattle, WA 98108More trials in Seattle
- Velocity Clinical Research - Spokane · Spokane, WA 99218More trials in Spokane
WI
- Aspirus Cardiovascular Associates · Wausau, WI 54401More trials in Wausau
WV
- Vaught Neurological Services · Crab Orchard, WV 25827More trials in Crab Orchard