A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05882045Tipo: INTERVENTIONALInicio: 30 de may de 2023Fin estimado: 1 de may de 2026

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
Have established cardiovascular (CV) disease with at least 1 of the following:
prior myocardial infarction
prior ischemic or hemorrhagic stroke, or
symptomatic peripheral arterial disease
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Criterios de exclusión

Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a prior or planned surgical treatment of obesity.
Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
Have Type 1 diabetes.
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had pancreatitis.

Intervenciones

drug

Retatrutide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

CEDIC

CABA, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Buenos Aires, Argentina

MICA - Medicina e Investigación Cardiometabólica

Del Viso, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina