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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06962280Tipo: INTERVENTIONALInicio: 12 de may de 2025Fin estimado: 1 de jul de 2027

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

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

Buenos Aires Macula S.A

Buenos Aires, Argentina

Stat Research S.A.

Buenos Aires, Argentina

Mautalen Salud e Investigación

Buenos Aires, Argentina

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

Instituto Médico Catamarca IMEC

Rosario, Argentina

Investigaciones Clínicas Tucumán

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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