Last updated 2 days ago
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
12800 patients around the world
Available in Puerto Rico, United States, Brazil
Amgen
4Research sites
12800Patients around the world
This study is for people with
Cardiovascular disease
Obesity
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- Age ≥ 45 years at screening.BMI of ≥ 27 kg/m2 at screening.History of Atherosclerotic Cardiovascular Disease (ASCVD) as evidenced by at least one of the following.Prior MI.Prior ischemic stroke (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.
- History of any of the following within 60 days before screening: MI, hospitalization for unstable angina, coronary artery revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or transient ischemic attack (TIA).New York Heart Association (NYHA) class IV HF at screening or hospitalization for HF within 60 days before screening.Type 1 DM, or any type of diabetes with the exception of T2DM or history of gestational diabetes.For participants with a prior diagnosis of T2DM at screening.HbA1c > 10.0% (86 mmol/mol) at screening.History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before screening.One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness.History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.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 study.History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening.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), or total bilirubin (TBL) > 1.8 x ULN (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 (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.
Sites
Ruschel Medicina e Pesquisa Clínica
Recruiting
CPQuali Pesquisa Clínica
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Research and Cardiovascular Corp
Recruiting
StudyMARITIME-CV
SponsorAmgen
Study typeInterventional
Conditions
Cardiovascular diseaseObesity
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07037433
