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)
NCT ID: NCT06297603
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
320 participants
INTERVENTIONAL
2024-03-15
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Retatrutide Dose 1
Participants will receive retatrutide administered subcutaneously (SC).
Retatrutide
Administered SC
Retatrutide Dose 2
Participants will receive retatrutide administered SC.
Retatrutide
Administered SC
Retatrutide Dose 3
Participants will receive retatrutide administered SC.
Retatrutide
Administered SC
Placebo
Participants will receive placebo administered SC.
Placebo
Administered SC
Interventions
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Retatrutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
* Have moderate or severe renal impairment
* Have been on the following stable diabetes treatment during 90 days prior to screening
* basal insulin (≥20 International Units (IU)/day) with or without
* metformin and/or SGLT2 inhibitor
* 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/m2)
Exclusion Criteria
* 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 a history of unstable or rapidly progressing renal disease
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification III or IV congestive heart failure
* Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
* Have any lifetime history of a suicide attempt
* Had chronic or acute pancreatitis
* Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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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)
Other Identifiers
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J1I-MC-GZQA
Identifier Type: OTHER
Identifier Source: secondary_id
18806
Identifier Type: -
Identifier Source: org_study_id