A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With Type-2 Diabetes (T2D)

TerminadoFase 2ClinicalTrials.gov

ID: NCT07030868Tipo: INTERVENTIONALInicio: 19 de jun de 2025Fin estimado: 29 de jul de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes. Participation in the study will last about 11 months.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

W8M-MC-GN02:
Assigned male at birth
Assigned female at birth, who are of non-childbearing potential
Have type 2 diabetes
W8M-MC-CWMM:
Have a BMI ≥27 kilograms per square meter (kg/m²)
Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss

Criterios de exclusión

W8M-MC-GN02:
Individuals who are of childbearing potential
Have a history of acute or chronic pancreatitis
Have any of the following cardiovascular conditions within 6 months prior to screening:
acute myocardial infarction
cerebrovascular accident (stroke)
unstable angina, or
hospitalization due to congestive heart failure.
W8M-MC-CWMM:
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening
Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma
Have poorly controlled hypertension
Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease
Have a history of symptomatic gallbladder disease within the past 2 years
Have a lifetime history of suicide attempts

Intervenciones

drug

LY6249492

Administered orally

drug

Placebo

Administered orally

Ubicaciones

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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