Resumen del Estudio
Este ensayo clínico de Fase 3 evalúa un medicamento innovador llamado Maridebart Cafraglutida (también conocido como MariTide o AMG 133). El estudio está diseñado para personas que viven con sobrepeso u obesidad y que ya tienen un historial de enfermedad cardiovascular aterosclerótica (como infartos previos, ictus o problemas de circulación en las piernas). El objetivo principal es determinar si la administración de este fármaco, sumado a su tratamiento médico habitual, es superior a un placebo para prevenir eventos cardiacos graves. Buscamos reducir el riesgo de muerte cardiovascular, infartos al corazón y accidentes cerebrovasculares en el futuro, ofreciendo una terapia metabólica avanzada.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar adultos mayores de 45 años con un Índice de Masa Corporal (IMC) ≥ 27 y antecedentes confirmados de enfermedad cardiovascular (infarto, ictus isquémico o enfermedad arterial periférica sintomática). No pueden participar quienes tengan diabetes tipo 1, insuficiencia cardíaca severa (clase IV), antecedentes de pancreatitis, o enfermedades hepáticas distintas al hígado graso metabólico (MASLD).
- 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.