A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06914895Tipo: INTERVENTIONALInicio: 25 de abr de 2025Fin estimado: 1 de dic de 2026

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have type 1 diabetes and on insulin treatment for at least one year prior to screening
Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study

Criterios de exclusión

Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
Have had chronic or acute pancreatitis
Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Intervenciones

drug

Tirzepatide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Investigaciones Medicas Imoba Srl

Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Argentina

CENUDIAB

Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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