nctId: NCT06297603 id: 18806 id: J1I-MC-GZQA type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3) overallStatus: RECRUITING date: 2024-03-15 date: 2026-09-11 date: 2026-10-09 date: 2024-03-07 date: 2024-04-11 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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 320 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Achieving HbA1c <7.0% measure: Percentage of Participants Achieving HbA1c ≤6.5% measure: Change from Baseline in Fasting Serum Glucose measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Achieving Weight Reduction of ≥5% measure: Percentage of Participants Achieving Weight Reduction of ≥10% measure: Percentage of Participants Achieving Weight Reduction of ≥15% measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction measure: Percent Change from Baseline in Non-HDL Cholesterol measure: Percent Change from Baseline in Triglycerides measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Institute of Arizona (CRI) - Sun City West status: RECRUITING city: Sun City West state: Arizona zip: 85375 country: United States name: Jalal Abbas role: PRINCIPAL_INVESTIGATOR lat: 33.66198 lon: -112.34127 facility: Diabetes and Endocrine Associates status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States name: Robert Lipetz role: PRINCIPAL_INVESTIGATOR lat: 32.76783 lon: -117.02308 facility: UCLA South Bay Endocrinology status: RECRUITING city: Torrance state: California zip: 90505 country: United States name: Dianne Cheung role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 facility: Northeast Research Institute (NERI) status: NOT_YET_RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Care Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Hira Siktel role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Cotton O'Neil Clinical Research Center status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States name: Alan Wynne role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: Billings Clinic status: NOT_YET_RECRUITING city: Billings state: Montana zip: 59101 country: United States name: Lauren Kleess role: PRINCIPAL_INVESTIGATOR lat: 45.78329 lon: -108.50069 facility: Sierra Nevada Specialty Care status: NOT_YET_RECRUITING city: Reno state: Nevada zip: 89511 country: United States name: David Howard role: PRINCIPAL_INVESTIGATOR lat: 39.52963 lon: -119.8138 facility: Albany Medical College, Division of Community Endocrinology status: NOT_YET_RECRUITING city: Albany state: New York zip: 12203 country: United States name: Robert Busch role: PRINCIPAL_INVESTIGATOR lat: 42.65258 lon: -73.75623 facility: Research Foundation of SUNY - University of Buffalo status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14221 country: United States name: Ajay Chaudhuri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 facility: NYC Research INC status: RECRUITING city: Long Island City state: New York zip: 11106 country: United States name: Anastasios Manessis role: PRINCIPAL_INVESTIGATOR lat: 40.74482 lon: -73.94875 facility: University of North Carolina Medical Center status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Klara Klein role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 facility: Lucas Research, Inc. status: NOT_YET_RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States name: Anthony Barber role: PRINCIPAL_INVESTIGATOR lat: 35.73319 lon: -81.3412 facility: Cleveland Clinic status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Willy Marcos Valencia role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Central States Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Sarah Land role: PRINCIPAL_INVESTIGATOR lat: 36.15398 lon: -95.99277 facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States name: Daniel Austin role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: AM Diabetes & Endocrinology Center status: NOT_YET_RECRUITING city: Bartlett state: Tennessee zip: 38133 country: United States name: Kashif Latif role: PRINCIPAL_INVESTIGATOR lat: 35.20453 lon: -89.87398 facility: Dallas Diabetes Research Center status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Juno Research status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77040 country: United States name: Damaris Vega role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Endocrine Ips, Pllc status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77079 country: United States name: Prashant Koshy role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Southern Endocrinology Associates status: NOT_YET_RECRUITING city: Mesquite state: Texas zip: 75149 country: United States name: Sumana Gangi role: PRINCIPAL_INVESTIGATOR lat: 32.7668 lon: -96.59916 facility: Diabetes & Endocrine Treatment Specialists status: NOT_YET_RECRUITING city: Sandy state: Utah zip: 84093 country: United States name: Timothy Graham role: PRINCIPAL_INVESTIGATOR lat: 40.59161 lon: -111.8841 facility: CEDIC status: NOT_YET_RECRUITING city: Caba state: Buenos Aires zip: C1060ABN country: Argentina name: Elizabeth Gelersztein role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro de Investigaciones Metabólicas (CINME) status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: 1056 country: Argentina name: Federico Perez Manghi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CIMeL Clinical Research status: NOT_YET_RECRUITING city: Lanus state: Buenos Aires zip: B1824KAJ country: Argentina name: Mariano Chahin role: PRINCIPAL_INVESTIGATOR lat: -34.70252 lon: -58.3955 facility: Centro de Investigaciones Médicas Mar del Plata status: NOT_YET_RECRUITING city: Mar del Plata state: Buenos Aires zip: 7600 country: Argentina name: Andres Alvarisqueta role: PRINCIPAL_INVESTIGATOR lat: -38.00228 lon: -57.55754 facility: DIM Clínica Privada status: NOT_YET_RECRUITING city: Ramos Mejía state: Buenos Aires zip: B1704ETD country: Argentina name: Alejandra Camino role: PRINCIPAL_INVESTIGATOR lat: -34.6551 lon: -58.55318 facility: Investigaciones Medicas Imoba Srl status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1056ABH country: Argentina name: Silvia Orio role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Médico Viamonte status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1120AAC country: Argentina name: Diego Aizenberg role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Instituto de Investigaciones Clinicas Zarate status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: 2000 country: Argentina name: Marisa Vico role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Instituto de Investigaciones Clinicas Rosario status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: S2000CVD country: Argentina name: Maximiliano Sicer role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Centro Médico Colón status: NOT_YET_RECRUITING city: Córdoba zip: 5003 country: Argentina name: Maria Parody role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: Centro de Endocrinologia Alcantara Gonzalez status: NOT_YET_RECRUITING city: Bayamon zip: 00959 country: Puerto Rico name: Altagracia Alcantara -Gonzalez role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: Private Practice - Dr. Paola Mansilla-Letelier status: NOT_YET_RECRUITING city: Guaynabo zip: 00970 country: Puerto Rico name: Paola Mansilla-Letelier role: PRINCIPAL_INVESTIGATOR lat: 18.35745 lon: -66.111 facility: Endocrinologist Metabolic Clinic & Research Institute status: NOT_YET_RECRUITING city: San Juan zip: 00921 country: Puerto Rico name: Martha Gomez-Cuellar role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 facility: Panthera Biopartners - Preston status: NOT_YET_RECRUITING city: Preston state: England zip: PR2 9QB country: United Kingdom name: Reem Handforth role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 facility: Lister Hospital status: NOT_YET_RECRUITING city: Stevenage state: Hertfordshire zip: SG1 4AB country: United Kingdom name: Adie Viljoen role: PRINCIPAL_INVESTIGATOR lat: 51.90224 lon: -0.20256 facility: Panthera Biopartners - Manchester status: NOT_YET_RECRUITING city: Rochdale state: Manchester zip: OL11 4AU country: United Kingdom name: Krishnakumar Radhakrishnan role: PRINCIPAL_INVESTIGATOR lat: 53.61766 lon: -2.1552 facility: Panthera Biopartners - Glasgow status: NOT_YET_RECRUITING city: Glasgow state: Scotland zip: G51 4LB country: United Kingdom name: Raghavendra Madimchetty role: PRINCIPAL_INVESTIGATOR lat: 55.86515 lon: -4.25763 hasResults: False