NCT06260722Active, not recruitingPhase 3
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1250 (estimated)
- First submitted
- 8 Feb 2024
- Start date
- 21 Feb 2024
- Primary completion date
- 27 Aug 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06260722
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1250
- From 21 Feb 2024 to the primary completion date, 27 Aug 2026
- 77 sites in 5 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) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label 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% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
- Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
- Are of stable weight for at least 90 days prior to screening
- Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (77)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mautalen Salud e Investigación 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 |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada 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 |
| Stat Research S.A. 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 |
| CEMEDIAB Coordinator of this site? Confirm its status | C.a.b.a. | Argentina | Unknown status |
| Instituto Centenario Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| CARE - Centro de Alergia y Enfermedades Respiratorias Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Centro Medico Privado San Vicente Diabetes 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 |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Coordinator of this site? Confirm its status | Godoy Cruz | Argentina | Unknown status |
| Centro de Investigaciones Clínicas Baigorria Coordinator of this site? Confirm its status | Granadero Baigorria | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Aggarwal and Associates Limited Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| University of Calgary - Clinical Trials Unit Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Alberta Diabetes Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Winterberry Research Inc. Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| The Wharton Medical Clinic Clinical Trials Inc Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Hamilton Medical Research Group Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| 9109-0126 Quebec Inc. Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| Maple Leaf Research Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Prime Health Clinical Research Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Private Practice - Dr. Nigel Jagan Coordinator of this site? Confirm its status | Whitby | Canada | Unknown status |
| Enclifar Ensayos Clínicos Farmacológicos Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Instituto de Diabetes, Obesidad y Nutricion Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Diseno y Planeacion en Investigacion Medica Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital de Jésus, I.A.P. Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| RM Pharma Specialists Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Cardiolink Clin Trials Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González 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 |
| Instituto Veracruzano en Investigación Clínica S.C. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Advanced Clinical Research, LLC Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Alabama - Department of Nutrition Sciences Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Brigham and Women's Hospital Diabetes Program Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Remington Davis Clinical Research Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| The Corvallis Clinic, P.C. Coordinator of this site? Confirm its status | Corvallis | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Arrow Clinical Trials Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Neighborhood Healthcare Institute of Health Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| NECCR PrimaCare Research Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Valley Institute of Research - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Medication Management Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Pacific Diabetes & Endocrine Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MedStar Health Research Institute (MedStar Physician Based Research Network) Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| Rocky Mountain Clinical Research Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Palm Research Center Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Palm Research Center Sunset Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Long Beach Research Institute Coordinator of this site? Confirm its status | Long Beach | 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 |
| New Age Medical Research Corporation Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| South Broward Research Coordinator of this site? Confirm its status | Miramar | United States | Unknown status |
| IMA Clinical Research Monroe - Armand Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| IMA Clinical Research West Virginia Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Deaconess Clinic - Gateway Health Center Coordinator of this site? Confirm its status | Newburgh | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Valley Clinical Trials, Inc. Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Rancho Cucamonga Clinical Research Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Herman Clinical Research Coordinator of this site? Confirm its status | Suwanee | United States | Unknown status |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Central States Research Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Central Washington Health Services Association d/b/a Confluence Health Coordinator of this site? Confirm its status | Wenatchee | United States | Unknown status |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Clinical Research of Central Florida Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
| North Georgia Clinical Research Coordinator of this site? Confirm its status | Woodstock | United States | Unknown status |
| Medrasa Clinical Research Coordinator of this site? Confirm its status | Wylie | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.