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Clinical Trial Details

Trial ID: L3278
Source ID: NCT06260722
Associated Drug: Retatrutide
Title: Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Retatrutide|DRUG: Semaglutide
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c) (%), Baseline, Week 80 | Secondary: Change from Baseline in HbA1c (%), Baseline, Week 80|Percentage of Participants Who Achieve HbA1c ≤ 6.5%, Week 80|Percentage of Participants Who Achieve HbA1c < 5.7%, Week 80|Percent Change from Baseline in Body Weight, Week 80|Change from Baseline in Body Weight, Baseline, Week 80|Percentage of Participants Who Achieve Weight Reduction of ≥ 5%, Week 80|Percentage of Participants Who Achieve Weight Reduction of ≥ 10%, Week 80|Percentage of Participants Who Achieve Weight Reduction of ≥ 15%, Week 80|Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction, Week 80|Percent Change from Baseline in Triglycerides, Week 80|Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol, Week 80|Change from Baseline in Systolic Blood Pressure (SBP), Baseline, Week 80
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1250
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-21
Completion Date: 2027-03
Results First Posted:
Last Update Posted: 2025-03-03
Locations: University of Alabama - Department of Nutrition Sciences, Birmingham, Alabama, 35294, United States|Neighborhood Healthcare Institute of Health, Escondido, California, 92025, United States|Long Beach Research Institute, Long Beach, California, 90805, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, 91730, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Arrow Clinical Trials, Daytona Beach, Florida, 32117, United States|New Age Medical Research Corporation, Miami, Florida, 33186, United States|South Broward Research, Miramar, Florida, 33027, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Herman Clinical Research, Suwanee, Georgia, 30024, United States|North Georgia Clinical Research, Woodstock, Georgia, 30189, United States|Pacific Diabetes & Endocrine Center, Honolulu, Hawaii, 96817, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Deaconess Clinic - Gateway Health Center, Newburgh, Indiana, 47630, United States|IMA Clinical Research Monroe - Armand, Monroe, Louisiana, 71201, United States|MedStar Health Research Institute (MedStar Physician Based Research Network), Hyattsville, Maryland, 20782, United States|Brigham and Women's Hospital Diabetes Program, Boston, Massachusetts, 02115, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Palm Research Center Sunset, Las Vegas, Nevada, 89148, United States|NYC Research INC, Long Island City, New York, 11106, United States|Medication Management, Greensboro, North Carolina, 27405, United States|Remington Davis Clinical Research, Columbus, Ohio, 43215, United States|Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States|Central States Research, Tulsa, Oklahoma, 74136, United States|The Corvallis Clinic, P.C., Corvallis, Oregon, 97330, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States|Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States|Valley Institute of Research - Fort Worth, Fort Worth, Texas, 76164, United States|Juno Research, Houston, Texas, 77040, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Texas Valley Clinical Research, Weslaco, Texas, 78596, United States|Medrasa Clinical Research, Wylie, Texas, 75098, United States|Central Washington Health Services Association d/b/a Confluence Health, Wenatchee, Washington, 98801, United States|IMA Clinical Research West Virginia, Morgantown, West Virginia, 26505, United States|CARE - Centro de Alergia y Enfermedades Respiratorias, Ciudad Autónoma de Buenos Aires, Buenos Aires, 1414, Argentina|Stat Research S.A., Buenos Aires, Ciudad Autónoma De Buenos Aires, C1023AAB, Argentina|CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1061AAS, 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|CEMEDIAB, C.a.b.a., Ciudad Autónoma De Buenos Aires, C1205AAO, Argentina|Instituto Centenario, Caba, Ciudad Autónoma De Buenos Aires, 1204, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, C1425AGC, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, Córdoba, 5006, Argentina|CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Mendoza, 5501, Argentina|Centro de Investigaciones Clínicas Baigorria, Granadero Baigorria, Santa Fe, 2152, Argentina|Instituto de Investigaciones Clinicas Rosario, Rosario, Santa Fe, S2000CVD, Argentina|Fundación Respirar, Buenos Aires, C1426ABP, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aires, C1056ABI, Argentina|Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina|University of Calgary - Clinical Trials Unit, Calgary, Alberta, T2T 5C7, Canada|Alberta Diabetes Institute, Edmonton, Alberta, T6G 2E1, Canada|Centricity Research Brampton Endocrinology, Brampton, Ontario, L6S 0C6, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|Winterberry Research Inc., Hamilton, Ontario, L8J 0B6, Canada|The Wharton Medical Clinic Clinical Trials Inc, Hamilton, Ontario, L8L 5G8, Canada|Hamilton Medical Research Group, Hamilton, Ontario, L8L5G4, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ontario, N7T 4X3, Canada|Prime Health Clinical Research, Toronto, Ontario, M4S 1Y2, Canada|Maple Leaf Research, Toronto, Ontario, M5G 1K2, Canada|Private Practice - Dr. Nigel Jagan, Whitby, Ontario, L1N 2L1, Canada|9109-0126 Quebec Inc., Montreal, Quebec, H4N 2W2, Canada|RM Pharma Specialists, Mexico City, Distrito Federal, 03100, Mexico|Hospital de Jésus, I.A.P., Mexico City, Distrito Federal, 06090, Mexico|Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Distrito Federal, 11650, Mexico|Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico|Private Practice - Dr. Arechavaleta Granell Maria del Rosario, Guadalajara, Jalisco, 44670, Mexico|Instituto de Diabetes, Obesidad y Nutricion, Cuernavaca, Morelos, 62250, Mexico|Cardiolink Clin Trials, Monterrey, Nuevo León, 64060, Mexico|Clínica García Flores SC, Monterrey, Nuevo León, 64610, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico|Enclifar Ensayos Clínicos Farmacológicos Sc, Chihuahua, 31110, Mexico|Instituto Veracruzano en Investigación Clínica S.C., Veracruz, 91851, Mexico|Advanced Clinical Research, LLC, Bayamón, 00959, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, 00917, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT06260722