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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
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

Full criteria on ClinicalTrials.gov

Sites (75)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaUnknown status
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaUnknown status
Centro Médico Viamonte
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Buenos AiresArgentinaUnknown status
Mautalen Salud e Investigación
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Buenos AiresArgentinaUnknown status
Investigaciones Medicas Imoba Srl
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Buenos AiresArgentinaUnknown status
CIPREC
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Buenos AiresArgentinaUnknown status
CEDIC
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CABAArgentinaUnknown status
Centro Médico Colón
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CórdobaArgentinaUnknown status
Centro Diabetológico Dr. Waitman
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CórdobaArgentinaUnknown status
Centro de Investigaciones Clínicas Baigorria
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Granadero BaigorriaArgentinaUnknown status
CIMeL
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LanusArgentinaUnknown status
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaUnknown status
DIM Clínica Privada
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Ramos MejíaArgentinaUnknown status
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
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RosarioArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario
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RosarioArgentinaUnknown status
INECO Neurociencias Oroño
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RosarioArgentinaUnknown status
Instituto Médico Catamarca IMEC
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RosarioArgentinaUnknown status
Centro de Diabetes Curitiba
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CuritibaBrazilUnknown status
Instituto de Ensino e Pesquisa Clinica do Ceara
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FortalezaBrazilUnknown status
Centro de Pesquisas Clínicas Dr. Marco Mota
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MaceióBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
Praxis Pesquisa Médica
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Santo AndréBrazilUnknown status
Instituto de Pesquisa Clinica
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São PauloBrazilUnknown status
CEDOES
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VitóriaBrazilUnknown status
Southmead Hospital
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BristolUnited KingdomUnknown status
Edinburgh Royal Infirmary
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EdinburghUnited KingdomUnknown status
Panthera Biopartners - Glasgow
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GlasgowUnited KingdomUnknown status
George Eliot Hospital
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NuneatonUnited KingdomUnknown status
Panthera Biopartners - Preston
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PrestonUnited KingdomUnknown status
Panthera Biopartners - Manchester
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RochdaleUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
Lister Hospital
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StevenageUnited KingdomUnknown status
The Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
Clalit Health Services - Atlit
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AtlitIsraelUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Institute of Diabetes, Technology and Research - Clalit Health
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HerzliyaIsraelUnknown status
Edith Wolfson Medical Center
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HolonIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Clalit Health Services - Sakhnin Community Clinic
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SakhninIsraelUnknown status
Enclifar Ensayos Clínicos Farmacológicos Sc
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Chihuahua CityMexicoUnknown status
Diseno y Planeacion en Investigacion Medica
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GuadalajaraMexicoUnknown status
Medical Care and Research Sa de Cv
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MéridaMexicoUnknown status
FAICIC S. de R.L. de C.V.
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VeracruzMexicoUnknown status
Centro de Endocrinologia Alcantara Gonzalez
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BayamónPuerto RicoUnknown status
Isis Clinical Research Center
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GuaynaboPuerto RicoUnknown status
Mgcendo Llc
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San JuanPuerto RicoUnknown status
Albany Medical College, Division of Community Endocrinology
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AlbanyUnited StatesUnknown status
Kidney & Hypertension Center - Apple Valley
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Apple ValleyUnited StatesUnknown status
AM Diabetes & Endocrinology Center
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BartlettUnited StatesUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
Hope Clinical Research, Inc.
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Canoga ParkUnited StatesUnknown status
University of North Carolina Medical Center
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Chapel HillUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Orita Clinical Research
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DecaturUnited StatesUnknown status
Neighborhood Healthcare Institute of Health
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EscondidoUnited StatesUnknown status
Northeast Research Institute (NERI)
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Fleming IslandUnited StatesUnknown status
Prime Revival Research Institute, LLC
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Flower MoundUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
Nephrology Consultants
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HuntsvilleUnited StatesUnknown status
CARE Institute
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Idaho FallsUnited StatesUnknown status
EndoTrials Center for Clinical Research
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La MesaUnited StatesUnknown status
Excel Clinical Research, LLC
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Las VegasUnited StatesUnknown status
NYC Research Inc.
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Long Island CityUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
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PittsburghUnited StatesUnknown status
Diabetes & Endocrine Treatment Specialists
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Sandy CityUnited StatesUnknown status
Clinical Research Institute of Arizona (CRI) - Sun City West
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Sun City WestUnited StatesUnknown status
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesUnknown status
UCLA South Bay Endocrinology
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TorranceUnited StatesUnknown status
Central States Research
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TulsaUnited StatesUnknown status
Texas Valley Clinical Research
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WeslacoUnited StatesUnknown status
Encore Medical Research - Weston
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WestonUnited StatesUnknown status
Research Foundation of SUNY - University of Buffalo
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WilliamsvilleUnited StatesUnknown status

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