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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZQA | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide Dose 1 | Experimental | Participants will receive retatrutide administered subcutaneously (SC). |
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| Retatrutide Dose 2 | Experimental | Participants will receive retatrutide administered SC. |
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| Retatrutide Dose 3 | Experimental | Participants will receive retatrutide administered SC. |
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| Placebo | Placebo Comparator | Participants will receive placebo administered SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) (%) | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% | Week 52 | |
| Percentage of Participants Achieving HbA1c ≤6.5% | Week 52 | |
| Change from Baseline in Fasting Serum Glucose |
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Inclusion Criteria:
Have Type 2 Diabetes (T2D)
Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
Have moderate or severe renal impairment
Have been on the following stable diabetes treatment during 90 days prior to screening
Are of stable weight for at least 90 days prior to screening
Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants | Huntsville | Alabama | 35805 | United States | ||
| Clinical Research Institute of Arizona (CRI) - Sun City West |
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| Label | URL |
|---|---|
| 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) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 52 |
| Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL | Measured during the CGM session that occurs during 30 days prior to Week 52 | Week 52 |
| Percent Change from Baseline in Body Weight | Baseline, Week 52 |
| Change from Baseline in Body Weight | Baseline, Week 52 |
| Percentage of Participants Achieving Weight Reduction of ≥5% | Week 52 |
| Percentage of Participants Achieving Weight Reduction of ≥10% | Week 52 |
| Percentage of Participants Achieving Weight Reduction of ≥15% | Week 52 |
| Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction | Week 52 |
| Percent Change from Baseline in Non-HDL Cholesterol | Baseline, Week 52 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 52 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 52 |
| Sun City West |
| Arizona |
| 85375 |
| United States |
| Kidney & Hypertension Center - Apple Valley | Apple Valley | California | 92307 | United States |
| Hope Clinical Research, Inc. | Canoga Park | California | 91303 | United States |
| Neighborhood Healthcare Institute of Health | Escondido | California | 92025 | United States |
| EndoTrials Center for Clinical Research | La Mesa | California | 91942 | United States |
| UCLA South Bay Endocrinology | Torrance | California | 90505 | United States |
| Northeast Research Institute (NERI) | Fleming Island | Florida | 32003 | United States |
| Encore Medical Research - Weston | Weston | Florida | 33331 | United States |
| Orita Clinical Research | Decatur | Georgia | 30034 | United States |
| CARE Institute | Idaho Falls | Idaho | 83404 | United States |
| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Excel Clinical Research, LLC | Las Vegas | Nevada | 89109 | United States |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | 12203 | United States |
| NYC Research INC | Long Island City | New York | 11106 | United States |
| Research Foundation of SUNY - University of Buffalo | Williamsville | New York | 14221 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair | Pittsburgh | Pennsylvania | 15243 | United States |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Prime Revival Research Institute, LLC | Flower Mound | Texas | 75098 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | United States |
| Diabetes & Endocrine Treatment Specialists | Sandy City | Utah | 84093 | United States |
| Investigaciones Medicas Imoba Srl | Buenos Aires | C1056ABH | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1056ABI | Argentina |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| CIPREC | Buenos Aires | C1119ACN | Argentina |
| Centro Médico Viamonte | Buenos Aires | C1120AAC | Argentina |
| Mautalen Salud e Investigación | Buenos Aires | C1128AAF | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Buenos Aires | C1425AGC | Argentina |
| CEDIC | CABA | C1060ABN | Argentina |
| Centro Diabetológico Dr. Waitman | Córdoba | 5000 | Argentina |
| Centro Médico Colón | Córdoba | X5003DCP | Argentina |
| Centro de Investigaciones Clínicas Baigorria | Granadero Baigorria | 2152 | Argentina |
| CIMeL | Lanus | B1824KAJ | Argentina |
| Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | 7600 | Argentina |
| DIM Clínica Privada | Ramos Mejía | B1704ETD | Argentina |
| INECO Neurociencias Oroño | Rosario | 2000 | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | 2000 | Argentina |
| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | 2000 | Argentina |
| Instituto de Investigaciones Clinicas Rosario | Rosario | S2000CVD | Argentina |
| Centro de Diabetes Curitiba | Curitiba | 80810-040 | Brazil |
| Instituto de Ensino e Pesquisa Clinica do Ceara | Fortaleza | 60125058 | Brazil |
| Centro de Pesquisas Clínicas Dr. Marco Mota | Maceió | 57051-160 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 20241-180 | Brazil |
| Praxis Pesquisa Medica | Santo André | 09790790 | Brazil |
| Instituto de Pesquisa Clinica | São Paulo | 01223-001 | Brazil |
| CEDOES | Vitória | 29055450 | Brazil |
| Clalit Health Services - Atlit | Atlit | 3032301 | Israel |
| Soroka Medical Center | Beersheba | 8410101 | Israel |
| Institute of Diabetes, Technology and Research - Clalit Health | Herzliya | 4630945 | Israel |
| Edith Wolfson Medical Center | Holon | 5810001 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Clalit Health Services - Sakhnin Community Clinic | Sakhnin | 3081000 | Israel |
| Enclifar Ensayos Clínicos Farmacológicos Sc | Chihuahua City | 31110 | Mexico |
| Diseno y Planeacion en Investigacion Medica | Guadalajara | 44130 | Mexico |
| Medical Care and Research SA de CV | Mérida | 97070 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| Centro de Endocrinologia Alcantara Gonzalez | Bayamón | 00956 | Puerto Rico |
| Isis Clinical Research Center | Guaynabo | 00968 | Puerto Rico |
| Mgcendo Llc | San Juan | 00921 | Puerto Rico |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Edinburgh Royal Infirmary | Edinburgh | EH16 4SA | United Kingdom |
| Panthera Biopartners - Glasgow | Glasgow | G51 4LB | United Kingdom |
| George Eliot Hospital | Nuneaton | CV10 7DJ | United Kingdom |
| Panthera Biopartners - Preston | Preston | PR2 9QB | United Kingdom |
| Panthera Biopartners - Manchester | Rochdale | OL11 4AU | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
| The Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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