nctId: NCT06354660 id: 18804 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) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-07 date: 2024-04-09 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY 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. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Who Achieve HbA1c < 7.0% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% measure: Percentage of Participants Who Achieve HbA1c < 5.7% measure: Change from Baseline in Fasting Serum Glucose measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction measure: Percent Change from Baseline in Triglycerides measure: Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scottsdale Clinical Trials city: Scottsdale state: Arizona zip: 85260 country: United States name: Ernest Lee role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Tucson Clinical Research Institute city: Tucson state: Arizona zip: 85712 country: United States name: Girish Karamchandani role: PRINCIPAL_INVESTIGATOR lat: 32.22174 lon: -110.92648 facility: San Fernando Valley Health Institute city: Canoga Park state: California zip: 91304 country: United States name: Jeffrey London role: PRINCIPAL_INVESTIGATOR lat: 34.20112 lon: -118.59814 facility: Ark Clinical Research city: Long Beach state: California zip: 90815 country: United States name: Martha Navarro role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Northeast Research Institute (NERI) city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Ezy Medical Research city: Miami state: Florida zip: 33175 country: United States name: Manuel Fernandez role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Clinical Research of Central Florida city: Winter Haven state: Florida zip: 33880 country: United States name: Eduardo Torres role: PRINCIPAL_INVESTIGATOR lat: 28.02224 lon: -81.73286 facility: Trinity Research Centers city: Marietta state: Georgia zip: 30064 country: United States name: Jean Philippe role: PRINCIPAL_INVESTIGATOR lat: 33.9526 lon: -84.54993 facility: Cotton O'Neil Clinical Research Center - Central Office city: Topeka state: Kansas zip: 66606 country: United States name: Michael Cox role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: NECCR PrimaCare Research city: Fall River state: Massachusetts zip: 02721 country: United States name: Ehab Sorial role: PRINCIPAL_INVESTIGATOR lat: 41.70149 lon: -71.15505 facility: Clinical Research Professionals city: Chesterfield state: Missouri zip: 63005 country: United States name: Timothy Jennings role: PRINCIPAL_INVESTIGATOR lat: 38.66311 lon: -90.57707 facility: Boeson Research MSO city: Missoula state: Montana zip: 59804 country: United States name: Aubrey Remmers role: PRINCIPAL_INVESTIGATOR lat: 46.87215 lon: -113.994 facility: NJ MedCare & NJ Heart city: Linden state: New Jersey zip: 07036 country: United States name: Preet Randhawa role: PRINCIPAL_INVESTIGATOR lat: 40.62205 lon: -74.24459 facility: Accellacare - Wilmington - 1917 Tradd Court city: Wilmington state: North Carolina zip: 28401 country: United States name: John Parker role: PRINCIPAL_INVESTIGATOR lat: 34.22573 lon: -77.94471 facility: Providence Health Partners-Center for Clinical Research city: Dayton state: Ohio zip: 45439 country: United States name: Joni Koren role: PRINCIPAL_INVESTIGATOR lat: 39.75895 lon: -84.19161 facility: Clinical Research of Philadelphia city: Philadelphia state: Pennsylvania zip: 19114 country: United States name: Donna Gavarone role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians city: Uniontown state: Pennsylvania zip: 15401 country: United States name: Richard Cook II role: PRINCIPAL_INVESTIGATOR lat: 39.90008 lon: -79.71643 facility: Delricht Research - Tobias Gadson Boulevard - Charleston city: Charleston state: South Carolina zip: 29407 country: United States name: Edward Newton role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: Lifedoc Research - Lenox Park Drive city: Memphis state: Tennessee zip: 38115 country: United States name: Pedro Velasquez-Mieyer role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 facility: Clinical Research Associates Inc city: Nashville state: Tennessee zip: 37203 country: United States name: Stephan Sharp role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Prime Revival Research Institute city: Flower Mound state: Texas zip: 75028 country: United States name: WASIM HAQUE role: PRINCIPAL_INVESTIGATOR lat: 33.01457 lon: -97.09696 facility: Valley Institute of Research - Fort Worth city: Fort Worth state: Texas zip: 76164 country: United States name: alex guevara role: PRINCIPAL_INVESTIGATOR lat: 32.72541 lon: -97.32085 facility: Texas Valley Clinical Research city: Weslaco state: Texas zip: 78596 country: United States name: Eduardo Luna role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: Manassas Clinical Research Center city: Manassas state: Virginia zip: 20110 country: United States name: Nabil Andrawis role: PRINCIPAL_INVESTIGATOR lat: 38.75095 lon: -77.47527 facility: MultiCare Rockwood Cheney Clinic city: Cheney state: Washington zip: 99004 country: United States name: Jonathan Staben role: PRINCIPAL_INVESTIGATOR lat: 47.48739 lon: -117.57576 facility: Eastside Research Associates city: Redmond state: Washington zip: 98052 country: United States name: Chad Crystal role: PRINCIPAL_INVESTIGATOR lat: 47.67399 lon: -122.12151 facility: All India Institute of Medical Sciences city: Raipur state: Chhattisgarh zip: 492099 country: India name: Amritava Ghosh role: PRINCIPAL_INVESTIGATOR lat: 21.23333 lon: 81.63333 facility: Gujarat Endocrin Pvt Ltd city: Ahmedabad state: Gujarat zip: 380052 country: India name: parag Shah role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Nirmal Hospital city: Surat state: Gujarat zip: 395002 country: India name: Piyush Desai role: PRINCIPAL_INVESTIGATOR lat: 21.19594 lon: 72.83023 facility: Victoria Hospital, Bangalore Medical College And Research Institute city: Bangalore state: Karnataka zip: 560002 country: India name: Sivaranjani Holigi role: PRINCIPAL_INVESTIGATOR lat: 12.97194 lon: 77.59369 facility: Government Medical College - Kozhikode city: Kozhikode state: Kerala zip: 673008 country: India name: Chandni R role: PRINCIPAL_INVESTIGATOR lat: 11.24802 lon: 75.7804 facility: S C B Medical College and Hospital city: Cuttack state: Odisha zip: 753001 country: India name: Jayanta Panda role: PRINCIPAL_INVESTIGATOR lat: 20.46497 lon: 85.87927 facility: Eternal Heart Care Center and Research Institute city: Jaipur state: Rajasthan zip: 302020 country: India name: Jugal Gupta role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Brij Medical Centre Private Limited city: Kanpur state: Uttar Pradesh zip: 208020 country: India name: brij mohan role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran city: Mexico City state: Distrito Federal zip: 14080 country: Mexico name: Emma Chávez Manzanera role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Grupo Ollin Care city: Pachuca state: Hidalgo zip: 42000 country: Mexico name: Eduardo Zambrano Ruiz role: PRINCIPAL_INVESTIGATOR lat: 20.11697 lon: -98.73329 facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad city: Guadalajara state: Jalisco zip: 04460 country: Mexico name: Guillermo Gonzalez Galvez role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Unidad biomedica avanzada monterrey city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Centro de investigación y control metabólico city: Monterrey state: Nuevo León zip: 66465 country: Mexico name: Ramiro Banda Elizondo role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: EME RED Hospitalaria city: Mérida state: Yucatán zip: 97000 country: Mexico name: Hugo Laviada Molina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Arké SMO S.A de C.V city: Veracruz zip: 91910 country: Mexico name: Luis Aguilar Espinoza role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Dorado Medical Complex city: Dorado zip: 00646 country: Puerto Rico name: Luis Pagan-Cardona role: PRINCIPAL_INVESTIGATOR lat: 18.45883 lon: -66.26767 facility: Ponce Medical School Foundation Inc. city: Ponce zip: 00716 country: Puerto Rico name: Elizabeth Barranco Santana role: PRINCIPAL_INVESTIGATOR lat: 18.01108 lon: -66.61406 hasResults: False