Last updated 2 months ago

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

350 patients around the world

Available in Mexico, Argentina

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.

Eli Lilly and Company

10Research sites

350Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 2

Obesity

Requirements for the patient

To 75 Years

All Gender

Medical requirements

: 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.

: 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.
acute myocardial infarction.
cerebrovascular accident (stroke).
unstable angina .
hospitalization due to congestive heart failure, or
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.

Sites

Centro Médico Viamonte SRL - CABA, Buenos Aires

Recruiting

Av. Córdoba 2019, CABA, Buenos Aires

Centro Médico Maffei - CABA, Buenos Aires

Recruiting

Av. Cerviño 3375, CABA, Buenos Aires

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Recruiting

Viamonte, Cdad. Autónoma de Buenos Aires, Argentina

Consultorio de Investigación Clinica EMO SRL

Recruiting

Eduardo Acevedo 42, CABA, Buenos Aires

CEDIC Centro de Investigación Clínica - CABA, Buenos Aires

Recruiting

Jerónimo Salguero 2142, CABA, Buenos Aires

Cryptex Investigación Clínica

Recruiting

Av. Insurgentes Sur 101, México DF

CEDOPEC Centro Especializado en Diabetes, Obesidad y Enfermedades Cardiovasculares

Recruiting

Calle 3 #7 Col. Reforma Social, Miguel Hidalgo, C.P. 11650, CDMX

Virgen Cardiovascular Research S.C

Recruiting

Calle Tarascos #3469 Int. 309/310/311, Frac. Monraz, Guadalajara, Jalisco

Centro de Estudios de Investigación Metabólica y Cardiovascular SC

Recruiting

Diagonal Sur - Nte 305, Colinas de Universidad, 89110 Tampico, Tamps., Mexico

CINCAME (Centro de Investigación Cardiovascular y Metabólica)

Recruiting

Playa De Ti 1443, Las Flores 2da Secc, 22525 Tijuana, B.C., Mexico

SponsorEli Lilly and Company

Conditions

Diabetes mellitus type 2Obesity

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06037252