protocolSection identificationModule nctId: NCT06297603, orgStudyIdInfo id: 18806, secondaryIdInfos 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), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-09-11, completionDateStruct date: 2026-10-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-11, 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 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., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Percentage of Participants Achieving HbA1c <7.0%, secondaryOutcomes measure: Percentage of Participants Achieving HbA1c ≤6.5%, secondaryOutcomes measure: Change from Baseline in Fasting Serum Glucose, secondaryOutcomes measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Change from Baseline in Body Weight, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥5%, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥10%, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥15%, secondaryOutcomes measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction, secondaryOutcomes measure: Percent Change from Baseline in Non-HDL Cholesterol, secondaryOutcomes measure: Percent Change from Baseline in Triglycerides, secondaryOutcomes measure: Change from Baseline in Systolic Blood Pressure (SBP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Institute of Arizona (CRI) - Sun City West, status: RECRUITING, city: Sun City West, state: Arizona, zip: 85375, country: United States, contacts name: Jalal Abbas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.66198, lon: -112.34127, locations facility: Diabetes and Endocrine Associates, status: NOT_YET_RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, contacts name: Robert Lipetz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.76783, lon: -117.02308, locations facility: UCLA South Bay Endocrinology, status: RECRUITING, city: Torrance, state: California, zip: 90505, country: United States, contacts name: Dianne Cheung, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.83585, lon: -118.34063, locations facility: Northeast Research Institute (NERI), status: NOT_YET_RECRUITING, 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: Care Research, status: NOT_YET_RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Hira Siktel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Cotton O'Neil Clinical Research Center, status: RECRUITING, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: Alan Wynne, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Billings Clinic, status: NOT_YET_RECRUITING, city: Billings, state: Montana, zip: 59101, country: United States, contacts name: Lauren Kleess, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.78329, lon: -108.50069, locations facility: Sierra Nevada Specialty Care, status: NOT_YET_RECRUITING, city: Reno, state: Nevada, zip: 89511, country: United States, contacts name: David Howard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.52963, lon: -119.8138, locations facility: Albany Medical College, Division of Community Endocrinology, status: NOT_YET_RECRUITING, city: Albany, state: New York, zip: 12203, country: United States, contacts name: Robert Busch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Research Foundation of SUNY - University of Buffalo, status: NOT_YET_RECRUITING, city: Buffalo, state: New York, zip: 14221, country: United States, contacts name: Ajay Chaudhuri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, 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: University of North Carolina Medical Center, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Klara Klein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Lucas Research, Inc., status: NOT_YET_RECRUITING, city: Hickory, state: North Carolina, zip: 28601, country: United States, contacts name: Anthony Barber, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.73319, lon: -81.3412, locations facility: Cleveland Clinic, status: NOT_YET_RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Willy Marcos Valencia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, 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: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, contacts name: Daniel Austin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: AM Diabetes & Endocrinology Center, status: NOT_YET_RECRUITING, city: Bartlett, state: Tennessee, zip: 38133, country: United States, contacts name: Kashif Latif, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.20453, lon: -89.87398, locations facility: Dallas Diabetes Research Center, status: RECRUITING, 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: Juno Research, status: NOT_YET_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: Endocrine Ips, Pllc, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, contacts name: Prashant Koshy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Endocrinology Associates, status: NOT_YET_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: Diabetes & Endocrine Treatment Specialists, status: NOT_YET_RECRUITING, city: Sandy, state: Utah, zip: 84093, country: United States, contacts name: Timothy Graham, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.59161, lon: -111.8841, locations facility: CEDIC, status: NOT_YET_RECRUITING, city: Caba, state: Buenos Aires, zip: C1060ABN, country: Argentina, contacts name: Elizabeth Gelersztein, 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, state: Buenos Aires, zip: 1056, country: Argentina, contacts name: Federico Perez Manghi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CIMeL Clinical Research, status: NOT_YET_RECRUITING, city: Lanus, state: Buenos Aires, zip: B1824KAJ, country: Argentina, contacts name: Mariano Chahin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.70252, lon: -58.3955, locations facility: Centro de Investigaciones Médicas Mar del Plata, status: NOT_YET_RECRUITING, city: Mar del Plata, state: Buenos Aires, zip: 7600, country: Argentina, contacts name: Andres Alvarisqueta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -38.00228, lon: -57.55754, locations facility: DIM Clínica Privada, status: NOT_YET_RECRUITING, city: Ramos Mejía, state: Buenos Aires, zip: B1704ETD, country: Argentina, contacts name: Alejandra Camino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.6551, lon: -58.55318, locations facility: Investigaciones Medicas Imoba Srl, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1056ABH, country: Argentina, contacts name: Silvia Orio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Viamonte, status: NOT_YET_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: Instituto de Investigaciones Clinicas Zarate, status: NOT_YET_RECRUITING, city: Rosario, state: Santa Fe, zip: 2000, country: Argentina, contacts name: Marisa Vico, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, 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: Centro Médico Colón, status: NOT_YET_RECRUITING, city: Córdoba, zip: 5003, country: Argentina, contacts name: Maria Parody, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Centro de Endocrinologia Alcantara Gonzalez, status: NOT_YET_RECRUITING, city: Bayamon, zip: 00959, country: Puerto Rico, contacts name: Altagracia Alcantara -Gonzalez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.39856, lon: -66.15572, locations facility: Private Practice - Dr. Paola Mansilla-Letelier, status: NOT_YET_RECRUITING, city: Guaynabo, zip: 00970, country: Puerto Rico, contacts name: Paola Mansilla-Letelier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.35745, lon: -66.111, locations facility: Endocrinologist Metabolic Clinic & Research Institute, status: NOT_YET_RECRUITING, city: San Juan, zip: 00921, country: Puerto Rico, contacts name: Martha Gomez-Cuellar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.46633, lon: -66.10572, locations facility: Panthera Biopartners - Preston, status: NOT_YET_RECRUITING, city: Preston, state: England, zip: PR2 9QB, country: United Kingdom, contacts name: Reem Handforth, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.76282, lon: -2.70452, locations facility: Lister Hospital, status: NOT_YET_RECRUITING, city: Stevenage, state: Hertfordshire, zip: SG1 4AB, country: United Kingdom, contacts name: Adie Viljoen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.90224, lon: -0.20256, locations facility: Panthera Biopartners - Manchester, status: NOT_YET_RECRUITING, city: Rochdale, state: Manchester, zip: OL11 4AU, country: United Kingdom, contacts name: Krishnakumar Radhakrishnan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.61766, lon: -2.1552, locations facility: Panthera Biopartners - Glasgow, status: NOT_YET_RECRUITING, city: Glasgow, state: Scotland, zip: G51 4LB, country: United Kingdom, contacts name: Raghavendra Madimchetty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False