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)
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
2 other identifiers
interventional
320
7 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Mar 2024
Typical duration for phase_3 type-2-diabetes
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
December 24, 2025
December 1, 2025
2.5 years
March 1, 2024
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Baseline, Week 52
Secondary Outcomes (13)
Percentage of Participants Achieving HbA1c <7.0%
Week 52
Percentage of Participants Achieving HbA1c ≤6.5%
Week 52
Change from Baseline in Fasting Serum Glucose
Baseline, Week 52
Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL
Week 52
Percent Change from Baseline in Body Weight
Baseline, Week 52
- +8 more secondary outcomes
Study Arms (4)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide administered subcutaneously (SC).
Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide administered SC.
Retatrutide Dose 3
EXPERIMENTALParticipants will receive retatrutide administered SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo administered SC.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have Type 2 Diabetes (T2D)
- 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)
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Nephrology Consultants
Huntsville, Alabama, 35805, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375, United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, 92307, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025, United States
EndoTrials Center for Clinical Research
La Mesa, California, 91942, United States
UCLA South Bay Endocrinology
Torrance, California, 90505, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Orita Clinical Research
Decatur, Georgia, 30034, United States
CARE Institute
Idaho Falls, Idaho, 83404, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Billings Clinic
Billings, Montana, 59101, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203, United States
NYC Research INC
Long Island City, New York, 11106, United States
Research Foundation of SUNY - University of Buffalo
Williamsville, New York, 14221, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, 75098, United States
Juno Research
Houston, Texas, 77040, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Diabetes & Endocrine Treatment Specialists
Sandy City, Utah, 84093, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
CEDIC
CABA, C1060ABN, Argentina
Centro Diabetológico Dr. Waitman
Córdoba, 5000, Argentina
Centro Médico Colón
Córdoba, X5003DCP, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
CIMeL
Lanús, B1824KAJ, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, 7600, Argentina
DIM Clínica Privada
Ramos Mejía, B1704ETD, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, 2000, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, S2000CVD, Argentina
Centro de Diabetes Curitiba
Curitiba, 80810-040, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, 60125058, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, 57051-160, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
Praxis Pesquisa Medica
Santo André, 09790790, Brazil
Instituto de Pesquisa Clinica
São Paulo, 01223-001, Brazil
CEDOES
Vitória, 29055450, Brazil
Clalit Health Services - Atlit
Atlit, 3032301, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, 4630945, Israel
Edith Wolfson Medical Center
Holon, 5810001, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, 3081000, Israel
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City, 31110, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, 44130, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Centro de Endocrinologia Alcantara Gonzalez
Bayamón, 00956, Puerto Rico
Isis Clinical Research Center
Guaynabo, 00968, Puerto Rico
Mgcendo Llc
San Juan, 00921, Puerto Rico
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, G51 4LB, United Kingdom
George Eliot Hospital
Nuneaton, CV10 7DJ, United Kingdom
Panthera Biopartners - Preston
Preston, PR2 9QB, United Kingdom
Panthera Biopartners - Manchester
Rochdale, OL11 4AU, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
The Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
March 15, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.