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Clinical Trial Details

Trial ID: L1763
Source ID: NCT06297603
Associated Drug: Retatrutide
Title: 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)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Retatrutide|DRUG: Placebo
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c) (%), Baseline, Week 52 | Secondary: 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, Measured during the CGM session that occurs during 30 days prior to Week 52, Week 52|Percent Change from Baseline in Body Weight, Baseline, Week 52|Change from Baseline in Body Weight, Baseline, Week 52|Percentage of Participants Achieving Weight Reduction of ≥5%, Week 52|Percentage of Participants Achieving Weight Reduction of ≥10%, Week 52|Percentage of Participants Achieving Weight Reduction of ≥15%, Week 52|Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction, Week 52|Percent Change from Baseline in Non-HDL Cholesterol, Baseline, Week 52|Percent Change from Baseline in Triglycerides, Baseline, Week 52|Change from Baseline in Systolic Blood Pressure (SBP), Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 320
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2026-10
Results First Posted:
Last Update Posted: 2025-04-18
Locations: 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 Research, 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|Sierra Nevada Specialty Care, Reno, Nevada, 89511, 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|Lucas Research, Inc., Hickory, North Carolina, 28601, United States|Cleveland Clinic, Cleveland, Ohio, 44195, 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, Utah, 84093, United States|CEDIC, Caba, Buenos Aires, C1060ABN, Argentina|CIMeL, Lanus, Buenos Aires, B1824KAJ, Argentina|Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina|DIM Clínica Privada, Ramos Mejía, Buenos Aires, B1704ETD, Argentina|Investigaciones Medicas Imoba Srl, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1056ABH, Argentina|CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1119ACN, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1120AAC, Argentina|Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1128AAF, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, C1425AGC, Argentina|Centro de Investigaciones Clínicas Baigorria, Granadero Baigorria, Santa Fe, 2152, Argentina|INECO Neurociencias Oroño, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Catamarca IMEC, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, Rosario, Santa Fe, 2000, Argentina|Instituto de Investigaciones Clinicas Rosario, Rosario, Santa Fe, S2000CVD, Argentina|CIPREC, Buenos Aires, C1061AAS, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aires, C1056ABI, Argentina|Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina|Centro Médico Colón, Córdoba, X5003DCP, Argentina|Centro de Pesquisas Clínicas Dr. Marco Mota, Maceio, Alagoas, 57051-160, Brazil|Instituto de Ensino e Pesquisa Clinica do Ceara, Fortaleza, Ceará, 60125058, Brazil|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Centro de Diabetes Curitiba, Curitiba, Paraná, 80810-040, Brazil|Praxis Pesquisa Medica, Santo Andre, São Paulo, 09790790, Brazil|Instituto de Pesquisa Clinica, Sao Paulo, São Paulo, 01223-001, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, 20241-180, Brazil|Soroka Medical Center, Be'er Sheva, HaDarom, 8410101, Israel|Institute of Diabetes, Technology and Research - Clalit Health, Herzliya, HaMerkaz, 4630945, Israel|Edith Wolfson Medical Center, Holon, HaMerkaz, 5810001, Israel|Sheba Medical Center, Ramat Gan, HaMerkaz, 5262100, Israel|Clalit Health Services - Atlit, Atlit, HaTsafon, 3032301, Israel|Clalit Health Services - Sakhnin Community Clinic, Sakhnin, HaTsafon, 3081000, Israel|Hadassah Medical Center, Jerusalem, Yerushalayim, 9112001, Israel|Rambam Health Care Campus, Haifa, Ḥeifā, 3109601, Israel|Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico|Medical Care and Research SA de CV, Merida, Yucatán, 97070, Mexico|Enclifar Ensayos Clínicos Farmacológicos Sc, Chihuahua, 31110, Mexico|Instituto Nacional de Cardiologia Ignacio Chavez, Mexico, 14080, Mexico|FAICIC S. de R.L. de C.V., Veracruz, 91900, Mexico|Centro de Endocrinologia Alcantara Gonzalez, Bayamon, 00959, Puerto Rico|Isis Clinical Research Center, Guaynabo, 00968, Puerto Rico|Mgcendo Llc, San Juan, 00921, Puerto Rico|Southmead Hospital, Bristol, Bristol, City Of, BS10 5NB, United Kingdom|Panthera Biopartners - Preston, Preston, England, PR2 9QB, United Kingdom|The Royal Cornwall Hospital, Truro, England, TR1 3LJ, United Kingdom|Lister Hospital, Stevenage, Hertfordshire, SG1 4AB, United Kingdom|Panthera Biopartners - Manchester, Rochdale, Manchester, OL11 4AU, United Kingdom|Salford Royal Hospital, Salford, Manchester, M6 8HD, United Kingdom|Edinburgh Royal Infirmary, Edinburgh, Midlothian, EH16 4SA, United Kingdom|Panthera Biopartners - Glasgow, Glasgow, Scotland, G51 4LB, United Kingdom|George Eliot Hospital, Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06297603

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress