A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

CompletadoFase 3ClinicalTrials.gov

ID: NCT05872620Tipo: INTERVENTIONALInicio: 5 de jun de 2023Fin estimado: 8 de ago de 2025

Traducción no disponible, mostrando original

Resumen

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:
either diet/exercise alone or
up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Criterios de exclusión

Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
Have had a history of chronic or acute pancreatitis.

Intervenciones

drug

Orforglipron

Administered orally

drug

Placebo

Administered orally

Ubicaciones

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

CEMEDIAB

C.a.b.a., Ciudad Aut, Argentina

Instituto Centenario

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Santa Fe Province, Argentina

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

Clínica Universitaria Reina Fabiola

Córdoba, Argentina

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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