Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04657016Tipo: INTERVENTIONALInicio: 29 de mar de 2021Fin estimado: 12 de may de 2023

Traducción no disponible, mostrando original

Resumen

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
History of at least one unsuccessful dietary effort to lose body weight

Criterios de exclusión

Diabetes mellitus
Change in body weight greater than 5 kg within 3 months prior to starting study
Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
History of pancreatitis
Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Any lifetime history of a suicide attempt

Intervenciones

drug

Tirzepatide

Administered SC

other

Placebo

Administered SC

Ubicaciones

Centro Médico Viamonte

CABA, Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

CABA, Buenos Aires, Argentina

Instituto Centenario

CABA, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Stat Research S.A.

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Glenny Corp

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

CEMEDIAB

C.a.b.a., Ciudad Autónoma de Buenos Aire, Argentina

Instituto Médico Especializado (IME)

Buenos Aires, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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