protocolSection identificationModule nctId: NCT06260722, orgStudyIdInfo id: 18805, secondaryIdInfos id: J1I-MC-GZBZ, type: OTHER, domain: Eli Lilly and Company, briefTitle: 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), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2026-12-11, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1250, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Semaglutide, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Change from Baseline in HbA1c (%), secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 5.7%, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Change from Baseline in Body Weight, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction, secondaryOutcomes measure: Percent Change from Baseline in Triglycerides, secondaryOutcomes measure: Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol, secondaryOutcomes measure: Change from Baseline in Systolic Blood Pressure (SBP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama - Department of Nutrition Sciences, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: William Garvey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Neighborhood Healthcare Institute of Health, status: RECRUITING, city: Escondido, state: California, zip: 92025, country: United States, contacts name: James Schultz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.11921, lon: -117.08642, locations facility: Long Beach Research Institute, status: RECRUITING, city: Long Beach, state: California, zip: 90805, country: United States, contacts name: Ashley Duzik, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Rancho Cucamonga Clinical Research, status: RECRUITING, city: Rancho Cucamonga, state: California, zip: 91730, country: United States, contacts name: Steven Barag, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.1064, lon: -117.59311, locations facility: University of Colorado Anschutz Medical Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Neda Rasouli, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Arrow Clinical Trials, status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117, country: United States, contacts name: David Billmeier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.21081, lon: -81.02283, locations facility: New Age Medical Research Corporation, status: RECRUITING, city: Miami, state: Florida, zip: 33186, country: United States, contacts name: Janet Gersten, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: South Broward Research, status: RECRUITING, city: Miramar, state: Florida, zip: 33027, country: United States, contacts name: Kenneth Blaze, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.98731, lon: -80.23227, locations facility: Clinical Research of Central Florida, status: RECRUITING, city: Winter Haven, state: Florida, zip: 33880, country: United States, contacts name: Eduardo Torres, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Herman Clinical Research, status: RECRUITING, city: Suwanee, state: Georgia, zip: 30024, country: United States, contacts name: Lee Herman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05149, lon: -84.0713, locations facility: Pacific Diabetes & Endocrine Center, status: RECRUITING, city: Honolulu, state: Hawaii, zip: 96813, country: United States, contacts name: ALAN PARSA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.30694, lon: -157.85833, locations facility: Rocky Mountain Clinical Research, status: RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Kevin Prier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Deaconess Clinic - Gateway Health Center, status: NOT_YET_RECRUITING, city: Newburgh, state: Indiana, zip: 47630, country: United States, contacts name: Renee Galen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.94449, lon: -87.40529, locations facility: IMA Clinical Research Monroe - Armand, status: RECRUITING, city: Monroe, state: Louisiana, zip: 71201, country: United States, contacts name: Clinton Guillory, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.50931, lon: -92.1193, locations facility: MedStar Health Research Institute (MedStar Physician Based Research Network), status: RECRUITING, city: Hyattsville, state: Maryland, zip: 20782, country: United States, contacts name: Jean Park, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95594, lon: -76.94553, locations facility: Brigham and Women's Hospital Diabetes Program, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Vanita Aroda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: NECCR PrimaCare Research, status: RECRUITING, city: Fall River, state: Massachusetts, zip: 02721, country: United States, contacts name: Ehab Sorial, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.70149, lon: -71.15505, locations facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division, status: RECRUITING, city: Troy, state: Michigan, zip: 48098, country: United States, contacts name: Neil Fraser, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Palm Research Center Tenaya, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, contacts name: Samer Nakhle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: NYC Research INC, status: RECRUITING, city: Long Island City, state: New York, zip: 11106, country: United States, contacts name: Anastasios Manessis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.74482, lon: -73.94875, locations facility: Medication Management, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27405, country: United States, contacts name: James Franklin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Remington Davis Clinical Research, status: RECRUITING, city: Columbus, state: Ohio, zip: 43215, country: United States, contacts name: Elena Christofides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Intend Research, LLC, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73069, country: United States, contacts name: Lisa Connery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22257, lon: -97.43948, locations facility: Central States Research, status: RECRUITING, city: Tulsa, state: Oklahoma, zip: 74136, country: United States, contacts name: Sarah Land, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.15398, lon: -95.99277, locations facility: The Corvallis Clinic, P.C., status: RECRUITING, city: Corvallis, state: Oregon, zip: 97330, country: United States, contacts name: Brian Curtis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.56457, lon: -123.26204, locations facility: Thomas Jefferson University Hospital, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Serge Jabbour, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Dallas Diabetes Research Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Julio Rosenstock, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Valley Institute of Research - Fort Worth, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76164, country: United States, contacts name: alex guevara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Juno Research, status: RECRUITING, city: Houston, state: Texas, zip: 77040, country: United States, contacts name: Damaris Vega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Endocrinology Associates, status: RECRUITING, city: Mesquite, state: Texas, zip: 75149, country: United States, contacts name: Sumana Gangi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.7668, lon: -96.59916, locations facility: Texas Valley Clinical Research, status: RECRUITING, city: Weslaco, state: Texas, zip: 78596, country: United States, contacts name: Eduardo Luna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.15952, lon: -97.99084, locations facility: Medrasa Clinical Research, status: RECRUITING, city: Wylie, state: Texas, zip: 75098, country: United States, contacts name: Tanvir Ahmad, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01512, lon: -96.53888, locations facility: Central Washington Health Services Association d/b/a Confluence Health, status: RECRUITING, city: Wenatchee, state: Washington, zip: 98801, country: United States, contacts name: Anton Grasch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42346, lon: -120.31035, locations facility: Exemplar Research, status: RECRUITING, city: Morgantown, state: West Virginia, zip: 26505, country: United States, contacts name: WARD PAINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62953, lon: -79.9559, locations facility: CARE - Centro de Alergia y Enfermedades Respiratorias, status: NOT_YET_RECRUITING, city: Ciudad Autónoma de Buenos Aires, state: Buenos Aires, zip: 1414, country: Argentina, contacts name: Hernan Finkelstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Stat Research S.A., status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1023AAB, country: Argentina, contacts name: Lucas Gutnisky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CIPREC, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1061AAS, country: Argentina, contacts name: Cesar Zaidman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Viamonte, status: RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1120AAC, country: Argentina, contacts name: Diego Aizenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Mautalen Salud e Investigación, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1128AAF, country: Argentina, contacts name: José Fretes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CEMEDIAB, status: NOT_YET_RECRUITING, city: C.a.b.a., state: Ciudad Autónoma De Buenos Aires, zip: C1205AAO, country: Argentina, contacts name: Alejandro Chertkoff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Centenario, status: NOT_YET_RECRUITING, city: Caba, state: Ciudad Autónoma De Buenos Aires, zip: 1204, country: Argentina, contacts name: SUSANA SALZBERG, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, status: NOT_YET_RECRUITING, city: Ciudad Autonoma de Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1425AGC, country: Argentina, contacts name: Antonela Mainardi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Medico Privado San Vicente Diabetes, status: NOT_YET_RECRUITING, city: Cordoba, state: Córdoba, zip: 5006, country: Argentina, contacts name: Cecilia Luquez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, status: RECRUITING, city: Godoy Cruz, state: Mendoza, zip: 5501, country: Argentina, contacts name: Pedro Rosario Fabian Calella, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.92863, lon: -68.8351, locations facility: Centro de Investigaciones Clínicas Baigorria, status: RECRUITING, city: Granadero Baigorria, state: Santa Fe, zip: 2152, country: Argentina, contacts name: Juan Escalante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.85683, lon: -60.71754, locations facility: Instituto de Investigaciones Clinicas Rosario, status: NOT_YET_RECRUITING, city: Rosario, state: Santa Fe, zip: S2000CVD, country: Argentina, contacts name: Maximiliano Sicer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Fundación Respirar, status: RECRUITING, city: Buenos Aires, zip: C1426ABP, country: Argentina, contacts name: Maria De Salvo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro de Investigaciones Metabólicas (CINME), status: NOT_YET_RECRUITING, city: Ciudad Autónoma de Buenos Aires, zip: C1056ABJ, country: Argentina, contacts name: Federico Perez Manghi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Diabetológico Dr. Waitman, status: NOT_YET_RECRUITING, city: Córdoba, zip: 5000, country: Argentina, contacts name: JOSE POZZI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: University of Calgary - Clinical Trials Unit, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2T 5C7, country: Canada, contacts name: Ronald Sigal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Alberta Diabetes Institute, status: NOT_YET_RECRUITING, city: Edmonton, state: Alberta, zip: T6G 2E1, country: Canada, contacts name: Peter Senior, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, locations facility: Aggarwal and Associates Limited, status: RECRUITING, city: Brampton, state: Ontario, zip: L6T 0G1, country: Canada, contacts name: Naresh Aggarwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.68341, lon: -79.76633, locations facility: Dr. Steven V. Zizzo Medicine Professional Corporation, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8J 0B6, country: Canada, contacts name: Steven Zizzo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Wharton Medical Clinic, status: NOT_YET_RECRUITING, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, contacts name: Sean Wharton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hamilton Medical Research Group, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8M 1K7, country: Canada, contacts name: Richard Tytus, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Bluewater Clinical Research Group Inc., status: NOT_YET_RECRUITING, city: Sarnia, state: Ontario, zip: N7T 4X3, country: Canada, contacts name: John O'Mahony, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.97866, lon: -82.40407, locations facility: Prime Health Clinical Research, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M4S 1Y2, country: Canada, contacts name: Iris Shasha Gorfinkel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Maple Leaf Research, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1K2, country: Canada, contacts name: Graham Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Private Practice - Dr. Nigel Jagan, status: RECRUITING, city: Whitby, state: Ontario, zip: L1N 2L1, country: Canada, contacts name: Nigel Jagan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88342, lon: -78.93287, locations facility: 9109-0126 Quebec Inc., status: RECRUITING, city: Montreal, state: Quebec, zip: H4N 2W2, country: Canada, contacts name: Ronald Akhras, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: RM Pharma Specialists, status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 03100, country: Mexico, contacts name: Mariana Crespo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Hospital de Jésus, I.A.P., status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 06090, country: Mexico, contacts name: Efrain Villeda Espinosa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 11650, country: Mexico, contacts name: Melchor Alpizar Salazar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Diseno y Planeacion en Investigacion Medica, status: NOT_YET_RECRUITING, city: Guadalajara, state: Jalisco, zip: 44130, country: Mexico, contacts name: Cesar Calvo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario, status: NOT_YET_RECRUITING, city: Guadalajara, state: Jalisco, zip: 44670, country: Mexico, contacts name: Maria Arechavaleta Granell, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Instituto de Diabetes, Obesidad y Nutricion, status: NOT_YET_RECRUITING, city: Cuernavaca, state: Morelos, zip: 62250, country: Mexico, contacts name: Leobardo Sauque Reyna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.9261, lon: -99.23075, locations facility: Cardiolink Clin Trials, status: NOT_YET_RECRUITING, city: Monterrey, state: Nuevo León, zip: 64060, country: Mexico, contacts name: Elías García, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Clínica García Flores SC, status: NOT_YET_RECRUITING, city: Monterrey, state: Nuevo León, zip: 64610, country: Mexico, contacts name: Pedro Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Enclifar Ensayos Clínicos Farmacológicos Sc, status: NOT_YET_RECRUITING, city: Chihuahua, zip: 31110, country: Mexico, contacts name: Luis Nevarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63528, lon: -106.08889, locations facility: Instituto Veracruzano en Investigación Clínica S.C., status: NOT_YET_RECRUITING, city: Veracruz, zip: 91851, country: Mexico, contacts name: Rosa Luna Ceballos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Advanced Clinical Research, LLC, status: RECRUITING, city: Bayamón, zip: 00959, country: Puerto Rico, contacts name: Angel Comulada-Rivera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.39856, lon: -66.15572, locations facility: GCM Medical Group, PSC - Hato Rey Site, status: RECRUITING, city: San Juan, zip: 00917, country: Puerto Rico, contacts name: Gregorio Cortes-Maisonet, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.46633, lon: -66.10572, hasResults: False