El objetivo primario de este ensayo es demostrar que maridebart cafraglutida es superior al placebo cuando se administra como complemento al tratamiento estándar en la reducción de la morbilidad y mortalidad cardiovascular (CV).

Elegibilidad

Edad mínima: 45 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Ubicaciones

Centro Medico Viamonte

CABA, Buenos Aires, Argentina

RECRUITING

Imoba Investigaciones medicas

CABA, Buenos Aires, Argentina

RECRUITING

Conexa Investigacion Clinica SA

CABA, Buenos Aires, Argentina

RECRUITING

Stat Research

CABA, Buenos Aires, Argentina

RECRUITING

Cedic - Centro de Investigacion Clinica

CABA, Buenos Aires, Argentina

RECRUITING

Cemedic Centro de Especialidades Medicas

CABA, Buenos Aires, Argentina

RECRUITING

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

CABA, Buenos Aires, Argentina

RECRUITING

Consultorios Medicos Dr Besada

CABA, Buenos Aires, Argentina

RECRUITING

Fundacion Respirar - Consultorios Medicos Dr Doreski

CABA, Buenos Aires, Argentina

RECRUITING

Glenny Corp SA

CABA, Buenos Aires, Argentina

RECRUITING

Cinme - Centro de Investigaciones Metabolicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Ciprec - Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones Clinicas de San Nicolas

San Nicolás de los Arroyos, Buenos Aires, Argentina

RECRUITING

Go Centro Medico San Nicolas

Zárate, Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

RECRUITING

Centro Diabetologico Dr Waitman

Córdoba, Córdoba Province, Argentina

RECRUITING

Clinica Privada del Prado

Córdoba, Córdoba Province, Argentina

RECRUITING

Instituto Medico Rio Cuarto SA

Río Cuarto, Córdoba Province, Argentina

RECRUITING

mit - Medicina Investigacion y Tratamiento

Santa Rosa, La Pampa Province, Argentina

RECRUITING

CIPADi

Godoy Cruz, Mendoza Province, Argentina

RECRUITING

Instituto Medico Catamarca Imec

Rosario, Santa Fe Province, Argentina

RECRUITING

Centro Medico de Nutricion y Diabetes

CABA, Argentina

RECRUITING

INECO Neurociencias Oronio

Rosario, Argentina

RECRUITING

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

RECRUITING

Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo para evaluar el impacto de maridebart cafraglutida sobre los resultados cardiovasculares en participantes con enfermedad cardiovascular aterosclerótica y sobrepeso u obesidad

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Maridebart Cafraglutide

Placebo

Ubicaciones

Centro Medico Viamonte

Imoba Investigaciones medicas

Conexa Investigacion Clinica SA

Stat Research

Cedic - Centro de Investigacion Clinica

Cemedic Centro de Especialidades Medicas

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Consultorios Medicos Dr Besada

Fundacion Respirar - Consultorios Medicos Dr Doreski

Glenny Corp SA

Cinme - Centro de Investigaciones Metabolicas

Ciprec - Centro de Investigacion y Prevencion Cardiovascular

Centro de Investigaciones Medicas Mar del Plata

Instituto de Investigaciones Clinicas de San Nicolas

Go Centro Medico San Nicolas

Instituto de Investigaciones Clinicas Zarate

Centro Diabetologico Dr Waitman

Clinica Privada del Prado

Instituto Medico Rio Cuarto SA

mit - Medicina Investigacion y Tratamiento

CIPADi

Instituto Medico Catamarca Imec

Centro Medico de Nutricion y Diabetes

INECO Neurociencias Oronio

Centro de Investigaciones Clinicas del Litoral

Patrocinadores

Contactos

Amgen Call Center