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Clinical Trial Details

Trial ID: L5866
Source ID: NCT06354660
Associated Drug: Retatrutide
Title: 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)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Type 2
Interventions: DRUG: Retatrutide|DRUG: Placebo
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c) (%), Baseline, Week 40 | Secondary: Percentage of Participants Who Achieve HbA1c < 7.0%, Week 40|Percentage of Participants Who Achieve HbA1c ≤ 6.5%, Week 40|Percentage of Participants Who Achieve HbA1c < 5.7%, Week 40|Change from Baseline in Fasting Serum Glucose, Baseline, Week 40|Percent Change from Baseline in Body Weight, Baseline, Week 40|Change from Baseline in Body Weight, Baseline, Week 40|Percentage of Participants Who Achieve Weight Reduction of ≥ 5%, Week 40|Percentage of Participants Who Achieve Weight Reduction of ≥ 10%, Week 40|Percentage of Participants Who Achieve Weight Reduction of ≥ 15%, Week 40|Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction, Week 40|Percent Change from Baseline in Triglycerides, Baseline, Week 40|Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol, Baseline, Week 40|Change from Baseline in Systolic Blood Pressure (SBP), Baseline, Week 40
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 480
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-10
Completion Date: 2026-07
Results First Posted:
Last Update Posted: 2025-02-28
Locations: Scottsdale Clinical Trials, Scottsdale, Arizona, 85260, United States|Tucson Clinical Research Institute, Tucson, Arizona, 85712, United States|San Fernando Valley Health Institute, Canoga Park, California, 91304, United States|Ark Clinical Research, Long Beach, California, 90815, United States|Northeast Research Institute (NERI), Fleming Island, Florida, 32003, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Ezy Medical Research, Miami, Florida, 33175, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Trinity Research Centers, Marietta, Georgia, 30064, United States|Cotton O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Boeson Research MSO, Missoula, Montana, 59804, United States|NJ MedCare & NJ Heart, Linden, New Jersey, 07036, United States|Accellacare - Wilmington - 1917 Tradd Court, Wilmington, North Carolina, 28401, United States|Providence Health Partners-Center for Clinical Research, Dayton, Ohio, 45439, United States|Clinical Research of Philadelphia, Philadelphia, Pennsylvania, 19114, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Delricht Research - Tobias Gadson Boulevard - Charleston, Charleston, South Carolina, 29407, United States|Lifedoc Research - Lenox Park Drive, Memphis, Tennessee, 38115, United States|Clinical Research Associates Inc, Nashville, Tennessee, 37203, United States|Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States|Prime Revival Research Institute, LLC, Flower Mound, Texas, 75028, United States|Valley Institute of Research - Fort Worth, Fort Worth, Texas, 76164, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Texas Valley Clinical Research, Weslaco, Texas, 78596, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|MultiCare Rockwood Cheney Clinic, Cheney, Washington, 99004, United States|Eastside Research Associates, Redmond, Washington, 98052, United States|All India Institute of Medical Sciences, Raipur, Chhattisgarh, 492099, India|Gujarat Endocrin Pvt Ltd, Ahmedabad, Gujarat, 380052, India|Nirmal Hospital Pvt Ltd., Surat, Gujarat, 395002, India|Victoria Hospital, Bangalore Medical College And Research Institute, Bangalore, Karnataka, 560002, India|Government Medical College - Kozhikode, Kozhikode, Kerala, 673008, India|All India Institute of Medical Sciences, Bhubaneswar, Odisha, 751019, India|Eternal Heart Care Center and Research Institute, Jaipur, Rajasthan, 302020, India|Brij Medical Centre Private Limited, Kanpur, Uttar Pradesh, 208020, India|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Distrito Federal, 14080, Mexico|Grupo Ollin Care, Pachuca, Hidalgo, 42000, Mexico|Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Jalisco, 04460, Mexico|Unidad biomedica avanzada monterrey, Monterrey, Nuevo León, 64460, Mexico|Clínica García Flores SC, Monterrey, Nuevo León, 64610, Mexico|Centro de investigación y control metabólico, San Nicolás de los Garza, Nuevo León, 66465, Mexico|Medical Care and Research SA de CV, Merida, Yucatán, 97070, Mexico|EME RED Hospitalaria, Mérida, Yucatán, 97000, Mexico|Arké SMO S.A de C.V, Veracruz, 91910, Mexico|Dorado Medical Complex, Dorado, 00646, Puerto Rico|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT06354660

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress