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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBY | 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 inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide Dose Level 1 | Experimental | Participants will receive retatrutide administered subcutaneously (SC). |
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| Retatrutide Dose Level 2 | Experimental | Participants will receive retatrutide administered SC. |
|
| Retatrutide Dose Level 3 | Experimental | Participants will receive retatrutide administered SC. |
|
| 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 40 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Clinical Trials | Scottsdale | Arizona | 85260 | United States | ||
| Tucson Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42250575 | Derived | Bajaj HS, Welch M, Shah P, Luna E, Jaouimaa FZ, Liu B, Liu R, Chen Y, Patel H, Bartee A. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. 2026 Jun 13;407(10546):2402-2413. doi: 10.1016/S0140-6736(26)00967-0. Epub 2026 Jun 6. |
| Label | URL |
|---|---|
| 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) | 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. |
|
| 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 |
| 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 |
| Grupo Ollin Care | Pachuca | Hidalgo | 42000 | Mexico |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad | Guadalajara | Jalisco | 04460 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | Mexico City | 14080 | 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 |
| EME RED Hospitalaria | Mérida | Yucatán | 97000 | Mexico |
| Medical Care and Research SA de CV | Mérida | Yucatán | 97070 | 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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