Recruiting NCT07037433

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Phase III Interventional Atherosclerotic Cardiovascular Disease Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Maridebart Cafraglutide, Placebo.
Who it may be relevant to: Registry conditions: Atherosclerotic Cardiovascular Disease, Overweight, Obesity. Basic parameters: 45 years — 99 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +31
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Drug Placebo
Placebo will be administered SC.

Primary outcome measures

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE]) [Time frame: Up to approximately 35 months]
Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE) [Time frame: Up to approximately 35 months]

Secondary outcome measures (12)

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event [Time frame: Up to approximately 35 months]
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization [Time frame: Up to approximately 35 months]
Time to First MI [Time frame: Up to approximately 35 months]
Time to First Ischemic Stroke [Time frame: Up to approximately 35 months]
Time to CV Death [Time frame: Up to approximately 35 months]
Time to All-cause Death [Time frame: Up to approximately 35 months]
Time to First Coronary Revascularization [Time frame: Up to approximately 35 months]
Time to First HF Event [Time frame: Up to approximately 35 months]
Time to First HF Event or CV Death [Time frame: Up to approximately 35 months]
Time to First Unstable Angina Requiring Hospitalization [Time frame: Up to approximately 35 months]
Time to First Occurrence of MI or CV Death [Time frame: Up to approximately 35 months]
Time to First Occurrence of MI, Ischemic Stroke or All-cause Death [Time frame: Up to approximately 35 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment