RecruitingPhase 3

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

AZ

CA

DE

FL

GA

IA

ID

IL

IN

KS

KY

LA

MA

MD

MN

MO

MS

NC

NE

NJ

NV

NY

OH

OK

PA

RI

SC

SD

TN

TX

UT

VA

WA

WI

WV