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)

Last updated: May 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

Retatrutide

Placebo

Clinical Study ID

NCT06297603
18806
J1I-MC-GZQA
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 toscreening

  • 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)

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D)

  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6months prior to screening

  • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6months prior to screening

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema

  • Have a history of unstable or rapidly progressing renal disease

  • Have a prior or planned surgical treatment for obesity

  • Have New York Heart Association Functional Classification III or IV congestive heartfailure

  • Have had acute myocardial infarction, stroke, or were hospitalized for congestiveheart failure within 90 days prior to screening

  • Have a known clinically significant gastric emptying abnormality

  • Have a history of an active or untreated malignancy or are in remission from aclinically significant malignancy for less than 5 years

  • Have a family or personal history of medullary thyroid carcinoma or multipleendocrine neoplasia (MEN) syndrome Type 2.

  • Have any lifetime history of a suicide attempt

  • Had chronic or acute pancreatitis

  • Have taken prescribed or over-the-counter medication, or alternative remedies,intended to promote body weight reduction within 90 days prior to screening

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Retatrutide
Phase: 3
Study Start date:
March 15, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • CEDIC

    Caba, Buenos Aires C1060ABN
    Argentina

    Active - Recruiting

  • CIMeL

    Lanus, Buenos Aires B1824KAJ
    Argentina

    Active - Recruiting

  • CIMeL Clinical Research

    Lanus, Buenos Aires B1824KAJ
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires 7600
    Argentina

    Active - Recruiting

  • DIM Clínica Privada

    Ramos Mejía, Buenos Aires B1704ETD
    Argentina

    Active - Recruiting

  • CIPREC

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1119ACN
    Argentina

    Active - Recruiting

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Active - Recruiting

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1056ABH
    Argentina

    Active - Recruiting

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1128AAF
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe 2152
    Argentina

    Active - Recruiting

  • INECO Neurociencias Oroño

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto Médico Catamarca IMEC

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe S2000CVD
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Zarate

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Centro Médico Colón

    Córdoba, X5003DCP
    Argentina

    Active - Recruiting

  • Centro de Pesquisas Clínicas Dr. Marco Mota

    Maceio, Alagoas 57051-160
    Brazil

    Site Not Available

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza, Ceará 60125058
    Brazil

    Site Not Available

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Centro de Diabetes Curitiba

    Curitiba, Paraná 80810-040
    Brazil

    Site Not Available

  • Praxis Pesquisa Medica

    Santo Andre, São Paulo 09790790
    Brazil

    Site Not Available

  • Instituto de Pesquisa Clinica

    Sao Paulo, São Paulo 01223-001
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, HaMerkaz 4630945
    Israel

    Site Not Available

  • Edith Wolfson Medical Center

    Holon, HaMerkaz 5810001
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Clalit Health Services - Atlit

    Atlit, HaTsafon 3032301
    Israel

    Site Not Available

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, HaTsafon 3081000
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, Ḥeifā 3109601
    Israel

    Site Not Available

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco 44130
    Mexico

    Site Not Available

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico, 14080
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900
    Mexico

    Site Not Available

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamon, 00956
    Puerto Rico

    Active - Recruiting

  • Isis Clinical Research Center

    Guaynabo, 00968
    Puerto Rico

    Active - Recruiting

  • Private Practice - Dr. Paola Mansilla-Letelier

    Guaynabo, 00968
    Puerto Rico

    Active - Recruiting

  • Endocrinologist Metabolic Clinic & Research Institute

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Mgcendo Llc

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Southmead Hospital

    Bristol, Bristol, City Of BS10 5NB
    United Kingdom

    Active - Recruiting

  • Panthera Biopartners - Preston

    Preston, England PR2 9QB
    United Kingdom

    Active - Recruiting

  • The Royal Cornwall Hospital

    Truro, England TR1 3LJ
    United Kingdom

    Active - Recruiting

  • Lister Hospital

    Stevenage, Hertfordshire SG1 4AB
    United Kingdom

    Active - Recruiting

  • Panthera Biopartners - Manchester

    Rochdale, Manchester OL11 4AU
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital

    Salford, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • Edinburgh Royal Infirmary

    Edinburgh, Midlothian EH16 4SA
    United Kingdom

    Active - Recruiting

  • Panthera Biopartners - Glasgow

    Glasgow, Scotland G51 4LB
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital

    Nuneaton, Warwickshire CV10 7DJ
    United Kingdom

    Active - Recruiting

  • Nephrology Consultants

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Clinical Research Institute of Arizona (CRI) - Sun City West

    Sun City West, Arizona 85375
    United States

    Active - Recruiting

  • Kidney & Hypertension Center - Apple Valley

    Apple Valley, California 92307
    United States

    Active - Recruiting

  • Hope Clinical Research, Inc.

    Canoga Park, California 91303
    United States

    Active - Recruiting

  • Neighborhood Healthcare Institute of Health

    Escondido, California 92025
    United States

    Active - Recruiting

  • Diabetes and Endocrine Associates

    La Mesa, California 91942
    United States

    Active - Recruiting

  • EndoTrials Center for Clinical Research

    La Mesa, California 91942
    United States

    Active - Recruiting

  • UCLA South Bay Endocrinology

    Torrance, California 90505
    United States

    Active - Recruiting

  • Northeast Research Institute (NERI)

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Encore Medical Research - Weston

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Orita Clinical Research

    Decatur, Georgia 30034
    United States

    Active - Recruiting

  • Care Research

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Billings Clinic

    Billings, Montana 59101
    United States

    Active - Recruiting

  • Excel Clinical Research, LLC

    Las Vegas, Nevada 89109
    United States

    Active - Recruiting

  • Sierra Nevada Specialty Care

    Reno, Nevada 89511
    United States

    Site Not Available

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York 12203
    United States

    Active - Recruiting

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York 14221
    United States

    Site Not Available

  • NYC Research INC

    Long Island City, New York 11106
    United States

    Active - Recruiting

  • Research Foundation of SUNY - University of Buffalo

    Williamsville, New York 14221
    United States

    Active - Recruiting

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    Hickory, North Carolina 28601
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Central States Research

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania 15243
    United States

    Active - Recruiting

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee 38133
    United States

    Active - Recruiting

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas 75098
    United States

    Active - Recruiting

  • Endocrine Ips, Pllc

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Juno Research

    Houston, Texas 77040
    United States

    Active - Recruiting

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Diabetes & Endocrine Treatment Specialists

    Sandy, Utah 84093
    United States

    Active - Recruiting

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