Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Last updated: February 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Placebo

Retatrutide

Clinical Study ID

NCT06354660
18804
J1I-MC-GZBY
  • 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 inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Type 2 Diabetes (T2D)

  • Have HbA1c ≥ 7.0% to ≤ 9.5%

  • Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening

  • 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/m^2)

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 an estimated glomerular filtration rate (eGFR) <15 milliliters/minute/1.73meter squared (mL/min/1.73 m^2) as determined by the central laboratory

  • Have a prior or planned surgical treatment for obesity

  • Have New York Heart Association Functional Classification IV congestive heartfailure

  • Have had an 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 any lifetime history of a suicide attempt

  • Had chronic or acute pancreatitis

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

  • 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: 480
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 10, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh 492099
    India

    Active - Recruiting

  • Gujarat Endocrin Pvt Ltd

    Ahmedabad, Gujarat 380052
    India

    Active - Recruiting

  • Nirmal Hospital

    Surat, Gujarat 395002
    India

    Site Not Available

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat 395002
    India

    Active - Recruiting

  • Victoria Hospital, Bangalore Medical College And Research Institute

    Bangalore, Karnataka 560002
    India

    Active - Recruiting

  • Government Medical College - Kozhikode

    Kozhikode, Kerala 673008
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha 751019
    India

    Site Not Available

  • S C B Medical College and Hospital

    Cuttack, Odisha 753001
    India

    Site Not Available

  • Eternal Heart Care Center and Research Institute

    Jaipur, Rajasthan 302020
    India

    Active - Recruiting

  • Brij Medical Centre Private Limited

    Kanpur, Uttar Pradesh 208020
    India

    Active - Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Distrito Federal 14080
    Mexico

    Active - Recruiting

  • Grupo Ollin Care

    Pachuca, Hidalgo 42000
    Mexico

    Site Not Available

  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad

    Guadalajara, Jalisco 04460
    Mexico

    Active - Recruiting

  • Centro de investigación y control metabólico

    Monterrey, Nuevo León 66465
    Mexico

    Site Not Available

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Active - Recruiting

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

  • Centro de investigación y control metabólico

    San Nicolás de los Garza, Nuevo León 66465
    Mexico

    Active - Recruiting

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

    Active - Recruiting

  • EME RED Hospitalaria

    Mérida, Yucatán 97000
    Mexico

    Active - Recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Dorado Medical Complex

    Dorado, 00646
    Puerto Rico

    Active - Recruiting

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Tucson Clinical Research Institute

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

    Active - Recruiting

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Active - Recruiting

  • Northeast Research Institute (NERI)

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Ezy Medical Research

    Miami, Florida 33175
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Trinity Research Centers

    Marietta, Georgia 30064
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • NECCR PrimaCare Research

    Fall River, Massachusetts 02721
    United States

    Active - Recruiting

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Active - Recruiting

  • Boeson Research MSO

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • NJ MedCare & NJ Heart

    Linden, New Jersey 07036
    United States

    Active - Recruiting

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio 45439
    United States

    Active - Recruiting

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • Delricht Research - Tobias Gadson Boulevard - Charleston

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • Lifedoc Research - Lenox Park Drive

    Memphis, Tennessee 38115
    United States

    Active - Recruiting

  • Clinical Research Associates Inc

    Nashville, Tennessee 37203
    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

    Flower Mound, Texas 75028
    United States

    Active - Recruiting

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas 75028
    United States

    Active - Recruiting

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas 76164
    United States

    Active - Recruiting

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Active - Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • MultiCare Rockwood Cheney Clinic

    Cheney, Washington 99004
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

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