protocolSection identificationModule nctId: NCT06354660, orgStudyIdInfo id: 18804, secondaryIdInfos id: J1I-MC-GZBY, type: OTHER, domain: Eli Lilly and Company, briefTitle: Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-19, 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 placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits., conditionsModule conditions: Diabetes Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 7.0%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 5.7%, secondaryOutcomes measure: Change from Baseline in Fasting Serum Glucose, 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: Scottsdale Clinical Trials, city: Scottsdale, state: Arizona, zip: 85260, country: United States, contacts name: Ernest Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Tucson Clinical Research Institute, city: Tucson, state: Arizona, zip: 85712, country: United States, contacts name: Girish Karamchandani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.22174, lon: -110.92648, locations facility: San Fernando Valley Health Institute, city: Canoga Park, state: California, zip: 91304, country: United States, contacts name: Jeffrey London, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Ark Clinical Research, city: Long Beach, state: California, zip: 90815, country: United States, contacts name: Martha Navarro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Northeast Research Institute (NERI), city: Fleming Island, state: Florida, zip: 32003, country: United States, contacts name: Senan Sultan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Ezy Medical Research, city: Miami, state: Florida, zip: 33175, country: United States, contacts name: Manuel Fernandez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Clinical Research of Central Florida, 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: Trinity Research Centers, city: Marietta, state: Georgia, zip: 30064, country: United States, contacts name: Jean Philippe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.9526, lon: -84.54993, locations facility: Cotton O'Neil Clinical Research Center - Central Office, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: Michael Cox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: NECCR PrimaCare Research, 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: Clinical Research Professionals, city: Chesterfield, state: Missouri, zip: 63005, country: United States, contacts name: Timothy Jennings, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.66311, lon: -90.57707, locations facility: Boeson Research MSO, city: Missoula, state: Montana, zip: 59804, country: United States, contacts name: Aubrey Remmers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87215, lon: -113.994, locations facility: NJ MedCare & NJ Heart, city: Linden, state: New Jersey, zip: 07036, country: United States, contacts name: Preet Randhawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.62205, lon: -74.24459, locations facility: Accellacare - Wilmington - 1917 Tradd Court, city: Wilmington, state: North Carolina, zip: 28401, country: United States, contacts name: John Parker, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Providence Health Partners-Center for Clinical Research, city: Dayton, state: Ohio, zip: 45439, country: United States, contacts name: Joni Koren, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Clinical Research of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19114, country: United States, contacts name: Donna Gavarone, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians, city: Uniontown, state: Pennsylvania, zip: 15401, country: United States, contacts name: Richard Cook II, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.90008, lon: -79.71643, locations facility: Delricht Research - Tobias Gadson Boulevard - Charleston, city: Charleston, state: South Carolina, zip: 29407, country: United States, contacts name: Edward Newton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Lifedoc Research - Lenox Park Drive, city: Memphis, state: Tennessee, zip: 38115, country: United States, contacts name: Pedro Velasquez-Mieyer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Clinical Research Associates Inc, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: Stephan Sharp, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Dallas Diabetes Research Center, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Dan Lender, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Prime Revival Research Institute, city: Flower Mound, state: Texas, zip: 75028, country: United States, contacts name: WASIM HAQUE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01457, lon: -97.09696, locations facility: Valley Institute of Research - Fort Worth, 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: Texas Valley Clinical Research, 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: Manassas Clinical Research Center, city: Manassas, state: Virginia, zip: 20110, country: United States, contacts name: Nabil Andrawis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.75095, lon: -77.47527, locations facility: MultiCare Rockwood Cheney Clinic, city: Cheney, state: Washington, zip: 99004, country: United States, contacts name: Jonathan Staben, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.48739, lon: -117.57576, locations facility: Eastside Research Associates, city: Redmond, state: Washington, zip: 98052, country: United States, contacts name: Chad Crystal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.67399, lon: -122.12151, locations facility: All India Institute of Medical Sciences, city: Raipur, state: Chhattisgarh, zip: 492099, country: India, contacts name: Amritava Ghosh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.23333, lon: 81.63333, locations facility: Gujarat Endocrin Pvt Ltd, city: Ahmedabad, state: Gujarat, zip: 380052, country: India, contacts name: parag Shah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Nirmal Hospital, city: Surat, state: Gujarat, zip: 395002, country: India, contacts name: Piyush Desai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.19594, lon: 72.83023, locations facility: Victoria Hospital, Bangalore Medical College And Research Institute, city: Bangalore, state: Karnataka, zip: 560002, country: India, contacts name: Sivaranjani Holigi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Government Medical College - 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