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Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Sponsor: Eli Lilly and Company
Summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Official title: A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2024-03-15
Completion Date
2026-11
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
Retatrutide
Administered SC
Placebo
Administered SC
Locations (76)
Nephrology Consultants
Huntsville, Alabama, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
EndoTrials Center for Clinical Research
La Mesa, California, United States
UCLA South Bay Endocrinology
Torrance, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Orita Clinical Research
Decatur, Georgia, United States
CARE Institute
Idaho Falls, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Billings Clinic
Billings, Montana, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
NYC Research INC
Long Island City, New York, United States
Research Foundation of SUNY - University of Buffalo
Williamsville, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Central States Research
Tulsa, Oklahoma, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, United States
Juno Research
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Diabetes & Endocrine Treatment Specialists
Sandy City, Utah, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina
CIPREC
Buenos Aires, Argentina
CIPREC
Buenos Aires, Argentina
Centro Médico Viamonte
Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
CEDIC
CABA, Argentina
Centro Diabetológico Dr. Waitman
Córdoba, Argentina
Centro Médico Colón
Córdoba, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Argentina
CIMeL
Lanús, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Argentina
DIM Clínica Privada
Ramos Mejía, Argentina
INECO Neurociencias Oroño
Rosario, Argentina
Instituto Médico Catamarca IMEC
Rosario, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Argentina
Centro de Diabetes Curitiba
Curitiba, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, Brazil
Praxis Pesquisa Medica
Santo André, Brazil
Instituto de Pesquisa Clinica
São Paulo, Brazil
CEDOES
Vitória, Brazil
Clalit Health Services - Atlit
Atlit, Israel
Soroka Medical Center
Beersheba, Israel
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, Israel
Edith Wolfson Medical Center
Holon, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, Israel
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Mexico
Medical Care and Research SA de CV
Mérida, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
Centro de Endocrinologia Alcantara Gonzalez
Bayamón, Puerto Rico
Isis Clinical Research Center
Guaynabo, Puerto Rico
Mgcendo Llc
San Juan, Puerto Rico
Southmead Hospital
Bristol, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, United Kingdom
George Eliot Hospital
Nuneaton, United Kingdom
Panthera Biopartners - Preston
Preston, United Kingdom
Panthera Biopartners - Manchester
Rochdale, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Lister Hospital
Stevenage, United Kingdom
The Royal Cornwall Hospital
Truro, United Kingdom