A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06037252Tipo: INTERVENTIONALInicio: 21 de sept de 2023Fin estimado: 1 de oct de 2026

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Descripción detallada

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
Have had stable body weight (±5%) during the 90 days preceding screening.
Have been diagnosed with Type 2 Diabetes (T2D).
Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Criterios de exclusión

acute myocardial infarction.
cerebrovascular accident (stroke).
unstable angina .
hospitalization due to congestive heart failure, or
Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
Have a prior or planned surgical treatment for obesity.
Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m².
Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
coronary artery revascularization.
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
Have a history of chronic or acute pancreatitis.

Intervenciones

drug

Tirzepatide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

CEDIC

CABA, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro Médico Viamonte

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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