Last updated 12 days ago

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

480 patients around the world

Available in Puerto Rico, Mexico, United States

Eli Lilly and Company

6Research sites

480Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 2

From 18 Years

All Gender

: Have Type 2 Diabetes (T2D)
Have HbA1c ≥ 7.0% to ≤ 9.5%
Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
Are of stable weight for at least 90 days prior to screening
Have a Body Mass Index (BMI) ≥ 23.0 kilograms per meter squared (kg/m^2)

: Have Type 1 Diabetes (T1D)
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
Have an estimated glomerular filtration rate (eGFR) <15 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) as determined by the central laboratory
Have a prior or planned surgical treatment for obesity
Have New York Heart Association Functional Classification IV congestive heart failure
Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
Have a known clinically significant gastric emptying abnormality
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have any lifetime history of a suicide attempt
Had chronic or acute pancreatitis
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening

Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán

Vasco de Quiroga 15, Belisario Domínguez Secc 16, 14080 Ciudad de México

Instituto Jalisciense de Investigación en Diabetes y Obesidad

Av. Manuel Acuña 2760 int. 202 Piso 2, esquina con Av. Rubén Darío, Col. Prados Providencia, Guadalajara, Jalisco

UBAM Unidad Biomédica Avanzada Monterrey

Calle Muzquiz #443 interior A, Col. Mitras Centro, Monterrey, Nuevo León, C.P. 64460

Medical Care & Research SA de CV

Calle 32 217 por Calle 11 y 13, Colonia Garcia Gineres, CP 97070 - Yucatán, Mérida

Eme Red Hospitalaria

56 y 56 A Calle 33, Centro, 97000 Mérida, Yucatán

Arke Estudios Clínicos S.A. de C.V. - Veracruz

Alacio Pérez 928, Consultorios 101 al 104, Ignacio Zaragoza, 91910 Veracruz

SponsorEli Lilly and Company

Conditions

Diabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06354660