NCT06297603Active, not recruitingPhase 3
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)
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, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor
Source: ClinicalTrials.gov · Last updated 20 Jul 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 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 15 Mar 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06297603
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 320
- From 15 Mar 2024 to the primary completion date, Oct 2026
- 75 sites in 7 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 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 a history of unstable or rapidly progressing renal disease
- Have New York Heart Association Functional Classification III or 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
- Have any lifetime history of a suicide attempt
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% (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
- basal insulin (≥20 International Units (IU)/day) with or without
- metformin and/or SGLT2 inhibitor
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (75)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigaciones Medicas Imoba Srl Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CEDIC Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Médico Colón Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro Diabetológico Dr. Waitman Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro de Investigaciones Clínicas Baigorria Coordinator of this site? Confirm its status | Granadero Baigorria | Argentina | Unknown status |
| CIMeL Coordinator of this site? Confirm its status | Lanus | Argentina | Unknown status |
| Centro de Investigaciones Medicas Mar Del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| DIM Clínica Privada Coordinator of this site? Confirm its status | Ramos Mejía | Argentina | Unknown status |
| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Instituto Médico Catamarca IMEC Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Instituto de Ensino e Pesquisa Clinica do Ceara Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Centro de Pesquisas Clínicas Dr. Marco Mota Coordinator of this site? Confirm its status | Maceió | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Praxis Pesquisa Médica Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Edinburgh Royal Infirmary Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Panthera Biopartners - Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| George Eliot Hospital Coordinator of this site? Confirm its status | Nuneaton | United Kingdom | Unknown status |
| Panthera Biopartners - Preston Coordinator of this site? Confirm its status | Preston | United Kingdom | Unknown status |
| Panthera Biopartners - Manchester Coordinator of this site? Confirm its status | Rochdale | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Lister Hospital Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Unknown status |
| The Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Clalit Health Services - Atlit Coordinator of this site? Confirm its status | Atlit | Israel | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Institute of Diabetes, Technology and Research - Clalit Health Coordinator of this site? Confirm its status | Herzliya | Israel | Unknown status |
| Edith Wolfson Medical Center Coordinator of this site? Confirm its status | Holon | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Clalit Health Services - Sakhnin Community Clinic Coordinator of this site? Confirm its status | Sakhnin | Israel | Unknown status |
| Enclifar Ensayos Clínicos Farmacológicos Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Diseno y Planeacion en Investigacion Medica 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 |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Centro de Endocrinologia Alcantara Gonzalez Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| Isis Clinical Research Center Coordinator of this site? Confirm its status | Guaynabo | Puerto Rico | Unknown status |
| Mgcendo Llc Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Albany Medical College, Division of Community Endocrinology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Kidney & Hypertension Center - Apple Valley Coordinator of this site? Confirm its status | Apple Valley | United States | Unknown status |
| AM Diabetes & Endocrinology Center Coordinator of this site? Confirm its status | Bartlett | United States | Unknown status |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Hope Clinical Research, Inc. Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Orita Clinical Research Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Neighborhood Healthcare Institute of Health Coordinator of this site? Confirm its status | Escondido | 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 |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Nephrology Consultants Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| CARE Institute Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| EndoTrials Center for Clinical Research Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| Excel Clinical Research, LLC Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| NYC Research Inc. Coordinator of this site? Confirm its status | Long Island City | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Diabetes & Endocrine Treatment Specialists Coordinator of this site? Confirm its status | Sandy City | United States | Unknown status |
| Clinical Research Institute of Arizona (CRI) - Sun City West Coordinator of this site? Confirm its status | Sun City West | United States | Unknown status |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| UCLA South Bay Endocrinology Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Central States Research Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Encore Medical Research - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Research Foundation of SUNY - University of Buffalo Coordinator of this site? Confirm its status | Williamsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.