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New treatment option for Atherosclerotic Cardiovascular Disease
Official title Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
ClinicalTrials.gov ID: NCT07037433
What this study is testing
What is Maridebart Cafraglutide?
Maridebart Cafraglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atherosclerotic cardiovascular disease.
Also referred to as AMG 133, MariTide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 99
You may be able to join if
- 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).
You likely can't join if
- History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina...
- New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and...
- Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational...
- 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.
See the full eligibility 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Sheffield, Alabama, United States
- Phoenix, Arizona, United States
- Covina, California, United States
- Huntington Park, California, United States
- La Mesa, California, United States
- Lake Forest, California, United States
- Redding, California, United States
- San Diego, California, United States
- Spring Valley, California, United States
- Walnut Creek, California, United States
- West Hills, California, United States
- Wilmington, Delaware, United States
- Boca Raton, Florida, United States
- Edgewater, Florida, United States
- Fort Myers, Florida, United States
- Hialeah, Florida, United States
+ 569 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daphne, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Mobile, Alabama, United States; Sheffield, Alabama, United States; Phoenix, Arizona, United States and 583 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.