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)

Last updated: April 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Semaglutide

Retatrutide

Clinical Study ID

NCT06260722
18805
J1I-MC-GZBZ
  • Ages > 18
  • All Genders

Study Summary

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.

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 been on a stable diabetes treatment consisting of metformin ≥ 1500 milligramsper 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)

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) <45 milliliters/minute/1.73meter squared (mL/min/1.73 m^2) or lower than the country-specific threshold fordiscontinuing metformin therapy per local label as determined by the centrallaboratory

  • 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: 1250
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
February 21, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • CARE - Centro de Alergia y Enfermedades Respiratorias

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1414
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1061AAS
    Argentina

    Site Not Available

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1128AAF
    Argentina

    Site Not Available

  • Stat Research S.A.

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1023AAB
    Argentina

    Site Not Available

  • CEMEDIAB

    C.a.b.a., Ciudad Autónoma De Buenos Aires C1205AAO
    Argentina

    Site Not Available

  • Instituto Centenario

    Caba, Ciudad Autónoma De Buenos Aires 1204
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

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

    Site Not Available

  • Centro Medico Privado San Vicente Diabetes

    Cordoba, Córdoba 5006
    Argentina

    Site Not Available

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza 5501
    Argentina

    Site Not Available

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe 2152
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe S2000CVD
    Argentina

    Site Not Available

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000
    Argentina

    Site Not Available

  • University of Calgary - Clinical Trials Unit

    Calgary, Alberta T2T 5C7
    Canada

    Site Not Available

  • Alberta Diabetes Institute

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • Dr. Steven V. Zizzo Medicine Professional Corporation

    Hamilton, Ontario L8J 0B6
    Canada

    Active - Recruiting

  • Dr. Steven V. Zizzo Research Professional Corporation

    Hamilton, Ontario L8J 0B6
    Canada

    Active - Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario L8L5G4
    Canada

    Site Not Available

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    Canada

    Active - Recruiting

  • Winterberry Research Inc.

    Hamilton, Ontario L8J 0B6
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Stouffville Medical Centre

    Stouffville, Ontario L4A 1H2
    Canada

    Site Not Available

  • Maple Leaf Research

    Toronto, Ontario M5G 1K2
    Canada

    Site Not Available

  • Prime Health Clinical Research

    Toronto, Ontario M4S 1Y2
    Canada

    Site Not Available

  • Private Practice - Dr. Nigel Jagan

    Whitby, Ontario L1N 2L1
    Canada

    Site Not Available

  • 9109-0126 Quebec Inc.

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Germany

    Site Not Available

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Distrito Federal 11650
    Mexico

    Site Not Available

  • Hospital de Jésus, I.A.P.

    Mexico City, Distrito Federal 06090
    Mexico

    Site Not Available

  • RM Pharma Specialists

    Mexico City, Distrito Federal 03100
    Mexico

    Site Not Available

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco 44130
    Mexico

    Site Not Available

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza 5501
    Mexico

    Site Not Available

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos 62250
    Mexico

    Site Not Available

  • Cardiolink Clin Trials

    Monterrey, Nuevo León 64060
    Mexico

    Site Not Available

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851
    Mexico

    Site Not Available

  • Advanced Clinical Research, LLC

    Bayamón, 00959
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • University of Alabama - Department of Nutrition Sciences

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Neighborhood Healthcare Institute of Health

    Escondido, California 92025
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Arrow Clinical Trials

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • New Age Medical Research Corporation

    Miami, Florida 33186
    United States

    Site Not Available

  • South Broward Research

    Miramar, Florida 33027
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Herman Clinical Research

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Deaconess Clinic - Gateway Health Center

    Newburgh, Indiana 47630
    United States

    Site Not Available

  • IMA Clinical Research Monroe - Armand

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • MedStar Health Research Institute (MedStar Physician Based Research Network)

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Brigham and Women's Hospital Diabetes Program

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • NECCR PrimaCare Research

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Site Not Available

  • Palm Research Center Sunset

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Palm Research Center Tenaya

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • NYC Research INC

    Long Island City, New York 11106
    United States

    Site Not Available

  • Medication Management

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Remington Davis Clinical Research

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Central States Research

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas 76164
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Medrasa Clinical Research

    Wylie, Texas 75098
    United States

    Site Not Available

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Exemplar Research

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

  • IMA Clinical Research West Virginia

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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