NCT06354660CompletedPhase 3
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)
A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 537 (actual)
- First submitted
- 3 Apr 2024
- Start date
- 10 Apr 2024
- Primary completion date
- 22 Jan 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06354660
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 537
- From 10 Apr 2024 to the primary completion date, 22 Jan 2026
- 48 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
- Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have a prior or planned surgical treatment for obesity
- Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
- Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Other illness
- Have Type 1 Diabetes (T1D)
- Have New York Heart Association Functional Classification IV congestive heart failure
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- Have any lifetime history of a suicide attempt
- Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
Lab values
- Have an estimated glomerular filtration rate (eGFR) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) as determined by the central laboratory
Other
- Have a known clinically significant gastric emptying abnormality
- Had chronic or acute pancreatitis
Who the study is looking for
- Have Type 2 Diabetes (T2D)
- Have HbA1c ≥ 7.0% to ≤ 9.5%
- Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 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/m\^2)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gujarat Endocrin Pvt Ltd Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Victoria Hospital, Bangalore Medical College And Research Institute Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| Eternal Heart Care Center and Research Institute Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Brij Medical Centre Private Limited Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Government Medical College, Kozhikode Coordinator of this site? Confirm its status | Kozhikode | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Raipur | India | Unknown status |
| Nirmal Hospital Pvt Ltd. Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Eme Red Hospitalaria Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Unidad Biomedica Avanzada Monterrey Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Clínica García Flores SC Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Grupo Ollin Care Coordinator of this site? Confirm its status | Pachuca | Mexico | Unknown status |
| Centro de investigación y control metabólico Coordinator of this site? Confirm its status | San Nicolás de los Garza | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Dorado Medical Complex Coordinator of this site? Confirm its status | Dorado | Puerto Rico | Unknown status |
| Ponce Medical School Foundation Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| San Fernando Valley Health Institute Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| Delricht Research - Tobias Gadson Boulevard - Charleston Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| MultiCare Rockwood Cheney Clinic Coordinator of this site? Confirm its status | Cheney | United States | Unknown status |
| Clinical Research Professionals Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Providence Health Partners-Center for Clinical Research Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| NECCR PrimaCare Research Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Northeast Research Institute (NERI) Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| Prime Revival Research Institute, LLC Coordinator of this site? Confirm its status | Flower Mound | United States | Unknown status |
| Valley Institute of Research - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| NJ MedCare & NJ Heart Coordinator of this site? Confirm its status | Linden | United States | Unknown status |
| Ark Clinical Research Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Trinity Research Centers Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Lifedoc Research - Lenox Park Drive Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Ezy Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Boeson Research MSO Coordinator of this site? Confirm its status | Missoula | United States | Unknown status |
| Clinical Research Associates, Inc. Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Clinical Research of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Eastside Research Associates Coordinator of this site? Confirm its status | Redmond | United States | Unknown status |
| Scottsdale Clinical Trials Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Cotton O'Neil Clinical Research Center Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Tucson Clinical Research Institute Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Preferred Primary Care Physicians Coordinator of this site? Confirm its status | Uniontown | United States | Unknown status |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Accellacare - Wilmington - 1917 Tradd Court Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Clinical Research of Central Florida Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.