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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
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

Full criteria on ClinicalTrials.gov

Sites (77)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mautalen Salud e Investigación
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Buenos AiresArgentinaUnknown status
Centro Médico Viamonte
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Buenos AiresArgentinaUnknown status
Fundacion Respirar
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Buenos AiresArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaUnknown status
CIPREC
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Buenos AiresArgentinaUnknown status
Stat Research S.A.
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Buenos AiresArgentinaUnknown status
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaUnknown status
CEMEDIAB
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C.a.b.a.ArgentinaUnknown status
Instituto Centenario
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CABAArgentinaUnknown status
CARE - Centro de Alergia y Enfermedades Respiratorias
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Centro Medico Privado San Vicente Diabetes
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CórdobaArgentinaUnknown status
Centro Diabetológico Dr. Waitman
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CórdobaArgentinaUnknown status
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
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Godoy CruzArgentinaUnknown status
Centro de Investigaciones Clínicas Baigorria
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Granadero BaigorriaArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario
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RosarioArgentinaUnknown status
Aggarwal and Associates Limited
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BramptonCanadaUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
University of Calgary - Clinical Trials Unit
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CalgaryCanadaUnknown status
Alberta Diabetes Institute
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EdmontonCanadaUnknown status
Winterberry Research Inc.
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HamiltonCanadaUnknown status
The Wharton Medical Clinic Clinical Trials Inc
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HamiltonCanadaUnknown status
Hamilton Medical Research Group
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HamiltonCanadaUnknown status
9109-0126 Quebec Inc.
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MontrealCanadaUnknown status
Bluewater Clinical Research Group Inc.
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SarniaCanadaUnknown status
Maple Leaf Research
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TorontoCanadaUnknown status
Prime Health Clinical Research
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TorontoCanadaUnknown status
Private Practice - Dr. Nigel Jagan
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WhitbyCanadaUnknown status
Enclifar Ensayos Clínicos Farmacológicos Sc
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Chihuahua CityMexicoUnknown status
Instituto de Diabetes, Obesidad y Nutricion
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CuernavacaMexicoUnknown status
Diseno y Planeacion en Investigacion Medica
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GuadalajaraMexicoUnknown status
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
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Mexico CityMexicoUnknown status
Hospital de Jésus, I.A.P.
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Mexico CityMexicoUnknown status
RM Pharma Specialists
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Mexico CityMexicoUnknown status
Cardiolink Clin Trials
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MonterreyMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Clínica García Flores SC
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MonterreyMexicoUnknown status
Instituto Veracruzano en Investigación Clínica S.C.
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VeracruzMexicoUnknown status
Advanced Clinical Research, LLC
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BayamónPuerto RicoUnknown status
GCM Medical Group, PSC - Hato Rey Site
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San JuanPuerto RicoUnknown status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesUnknown status
University of Alabama - Department of Nutrition Sciences
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BirminghamUnited StatesUnknown status
Brigham and Women's Hospital Diabetes Program
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BostonUnited StatesUnknown status
Remington Davis Clinical Research
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ColumbusUnited StatesUnknown status
The Corvallis Clinic, P.C.
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CorvallisUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Arrow Clinical Trials
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Daytona BeachUnited StatesUnknown status
Neighborhood Healthcare Institute of Health
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EscondidoUnited StatesUnknown status
NECCR PrimaCare Research
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Fall RiverUnited StatesUnknown status
Valley Institute of Research - Fort Worth
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Fort WorthUnited StatesUnknown status
Medication Management
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GreensboroUnited StatesUnknown status
Pacific Diabetes & Endocrine Center
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HonoluluUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
MedStar Health Research Institute (MedStar Physician Based Research Network)
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HyattsvilleUnited StatesUnknown status
Rocky Mountain Clinical Research
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Idaho FallsUnited StatesUnknown status
Palm Research Center Tenaya
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Las VegasUnited StatesUnknown status
Palm Research Center Sunset
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Las VegasUnited StatesUnknown status
Long Beach Research Institute
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Long BeachUnited StatesUnknown status
NYC Research Inc.
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Long Island CityUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
New Age Medical Research Corporation
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MiamiUnited StatesUnknown status
South Broward Research
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MiramarUnited StatesUnknown status
IMA Clinical Research Monroe - Armand
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MonroeUnited StatesUnknown status
IMA Clinical Research West Virginia
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MorgantownUnited StatesUnknown status
Deaconess Clinic - Gateway Health Center
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NewburghUnited StatesUnknown status
Alliance for Multispecialty Research, LLC
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NormanUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Rancho Cucamonga Clinical Research
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Rancho CucamongaUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Herman Clinical Research
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SuwaneeUnited StatesUnknown status
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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TroyUnited StatesUnknown status
Central States Research
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TulsaUnited StatesUnknown status
Central Washington Health Services Association d/b/a Confluence Health
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WenatcheeUnited StatesUnknown status
Texas Valley Clinical Research
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WeslacoUnited StatesUnknown status
Clinical Research of Central Florida
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Winter HavenUnited StatesUnknown status
North Georgia Clinical Research
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WoodstockUnited StatesUnknown status
Medrasa Clinical Research
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WylieUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.