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)

April 15, 2024 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundacion Respirar
        • Principal Investigator:
          • Maria De Salvo
      • Ciudad Autónoma de Buenos Aires, Argentina, C1056ABJ
        • Not yet recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Federico Perez Manghi
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Centro Diabetológico Dr. Waitman
        • Principal Investigator:
          • JOSE POZZI
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1414
        • Not yet recruiting
        • CARE - Centro de Alergia y Enfermedades Respiratorias
        • Principal Investigator:
          • Hernan Finkelstein
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1023AAB
        • Not yet recruiting
        • Stat Research S.A.
        • Principal Investigator:
          • Lucas Gutnisky
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1120AAC
        • Recruiting
        • Centro Médico Viamonte
        • Principal Investigator:
          • Diego Aizenberg
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
        • Not yet recruiting
        • Mautalen Salud e Investigación
        • Principal Investigator:
          • José Fretes
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1061AAS
        • Not yet recruiting
        • CIPREC
        • Principal Investigator:
          • Cesar Zaidman
      • C.a.b.a., Ciudad Autónoma De Buenos Aires, Argentina, C1205AAO
        • Not yet recruiting
        • CEMEDIAB
        • Principal Investigator:
          • Alejandro Chertkoff
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1204
        • Not yet recruiting
        • Instituto Centenario
        • Principal Investigator:
          • SUSANA SALZBERG
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1425AGC
        • Not yet recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Principal Investigator:
          • Antonela Mainardi
    • Córdoba
      • Cordoba, Córdoba, Argentina, 5006
        • Not yet recruiting
        • Centro Medico Privado San Vicente Diabetes
        • Principal Investigator:
          • Cecilia Luquez
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina, 5501
        • Recruiting
        • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
        • Principal Investigator:
          • Pedro Rosario Fabian Calella
    • Santa Fe
      • Granadero Baigorria, Santa Fe, Argentina, 2152
        • Recruiting
        • Centro de Investigaciones Clínicas Baigorria
        • Principal Investigator:
          • Juan Escalante
      • Rosario, Santa Fe, Argentina, S2000CVD
        • Not yet recruiting
        • Instituto de Investigaciones Clinicas Rosario
        • Principal Investigator:
          • Maximiliano Sicer
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Not yet recruiting
        • University of Calgary - Clinical Trials Unit
        • Principal Investigator:
          • Ronald Sigal
      • Edmonton, Alberta, Canada, T6G 2E1
        • Not yet recruiting
        • Alberta Diabetes Institute
        • Principal Investigator:
          • Peter Senior
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Recruiting
        • Aggarwal and Associates Limited
        • Principal Investigator:
          • Naresh Aggarwal
      • Hamilton, Ontario, Canada, L8M 1K7
        • Recruiting
        • Hamilton Medical Research Group
        • Principal Investigator:
          • Richard Tytus
      • Hamilton, Ontario, Canada, L8L 5G8
        • Not yet recruiting
        • Wharton Medical Clinic
        • Principal Investigator:
          • Sean Wharton
      • Hamilton, Ontario, Canada, L8J 0B6
        • Recruiting
        • Dr. Steven V. Zizzo Medicine Professional Corporation
        • Principal Investigator:
          • Steven Zizzo
      • Sarnia, Ontario, Canada, N7T 4X3
        • Not yet recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
      • Toronto, Ontario, Canada, M5G 1K2
        • Recruiting
        • Maple Leaf Research
        • Principal Investigator:
          • Graham Smith
      • Toronto, Ontario, Canada, M4S 1Y2
        • Not yet recruiting
        • Prime Health Clinical Research
        • Principal Investigator:
          • Iris Shasha Gorfinkel
      • Whitby, Ontario, Canada, L1N 2L1
        • Recruiting
        • Private Practice - Dr. Nigel Jagan
        • Principal Investigator:
          • Nigel Jagan
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • Recruiting
        • 9109-0126 Quebec Inc.
        • Principal Investigator:
          • Ronald Akhras
  • Mexico
      • Chihuahua, Mexico, 31110
        • Not yet recruiting
        • Enclifar Ensayos Clínicos Farmacológicos Sc
        • Principal Investigator:
          • Luis Nevarez
      • Veracruz, Mexico, 91851
        • Not yet recruiting
        • Instituto Veracruzano en Investigación Clínica S.C.
        • Principal Investigator:
          • Rosa Luna Ceballos
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 11650
        • Not yet recruiting
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
        • Principal Investigator:
          • Melchor Alpizar Salazar
      • Mexico City, Distrito Federal, Mexico, 06090
        • Not yet recruiting
        • Hospital de Jésus, I.A.P.
        • Principal Investigator:
          • Efrain Villeda Espinosa
      • Mexico City, Distrito Federal, Mexico, 03100
        • Not yet recruiting
        • RM Pharma Specialists
        • Principal Investigator:
          • Mariana Crespo
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Not yet recruiting
        • Diseno y Planeacion en Investigacion Medica
        • Principal Investigator:
          • Cesar Calvo
      • Guadalajara, Jalisco, Mexico, 44670
        • Not yet recruiting
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
        • Principal Investigator:
          • Maria Arechavaleta Granell
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Not yet recruiting
        • Instituto de Diabetes, Obesidad y Nutricion
        • Principal Investigator:
          • Leobardo Sauque Reyna
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Not yet recruiting
        • Cardiolink Clin Trials
        • Principal Investigator:
          • Elías García
      • Monterrey, Nuevo León, Mexico, 64610
        • Not yet recruiting
        • Clínica García Flores SC
        • Principal Investigator:
          • Pedro Garcia
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Recruiting
        • Advanced Clinical Research, LLC
        • Principal Investigator:
          • Angel Comulada-Rivera
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • GCM Medical Group, PSC - Hato Rey Site
        • Principal Investigator:
          • Gregorio Cortes-Maisonet
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama - Department of Nutrition Sciences
        • Principal Investigator:
          • William Garvey
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Neighborhood Healthcare Institute of Health
        • Principal Investigator:
          • James Schultz
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute
        • Principal Investigator:
          • Ashley Duzik
      • Rancho Cucamonga, California, United States, 91730
        • Recruiting
        • Rancho Cucamonga Clinical Research
        • Principal Investigator:
          • Steven Barag
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Neda Rasouli
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
        • Principal Investigator:
          • David Billmeier
      • Miami, Florida, United States, 33186
        • Recruiting
        • New Age Medical Research Corporation
        • Principal Investigator:
          • Janet Gersten
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research
        • Principal Investigator:
          • Kenneth Blaze
      • Winter Haven, Florida, United States, 33880
        • Recruiting
        • Clinical Research of Central Florida
        • Principal Investigator:
          • Eduardo Torres
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Recruiting
        • Herman Clinical Research
        • Principal Investigator:
          • Lee Herman
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Pacific Diabetes & Endocrine Center
        • Principal Investigator:
          • ALAN PARSA
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rocky Mountain Clinical Research
        • Principal Investigator:
          • Kevin Prier
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Not yet recruiting
        • Deaconess Clinic - Gateway Health Center
        • Principal Investigator:
          • Renee Galen
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • IMA Clinical Research Monroe - Armand
        • Principal Investigator:
          • Clinton Guillory
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Recruiting
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
        • Principal Investigator:
          • Jean Park
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital Diabetes Program
        • Principal Investigator:
          • Vanita Aroda
      • Fall River, Massachusetts, United States, 02721
        • Recruiting
        • NECCR PrimaCare Research
        • Principal Investigator:
          • Ehab Sorial
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Principal Investigator:
          • Neil Fraser
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Palm Research Center Tenaya
        • Principal Investigator:
          • Samer Nakhle
    • New York
      • Long Island City, New York, United States, 11106
        • Recruiting
        • NYC Research INC
        • Principal Investigator:
          • Anastasios Manessis
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Medication Management
        • Principal Investigator:
          • James Franklin
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington Davis Clinical Research
        • Principal Investigator:
          • Elena Christofides
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Intend Research, LLC
        • Principal Investigator:
          • Lisa Connery
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Central States Research
        • Principal Investigator:
          • Sarah Land
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • The Corvallis Clinic, P.C.
        • Principal Investigator:
          • Brian Curtis
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Serge Jabbour
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dallas Diabetes Research Center
        • Principal Investigator:
          • Julio Rosenstock
      • Fort Worth, Texas, United States, 76164
        • Recruiting
        • Valley Institute of Research - Fort Worth
        • Principal Investigator:
          • alex guevara
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Principal Investigator:
          • Damaris Vega
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Southern Endocrinology Associates
        • Principal Investigator:
          • Sumana Gangi
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Principal Investigator:
          • Eduardo Luna
      • Wylie, Texas, United States, 75098
        • Recruiting
        • Medrasa Clinical Research
        • Principal Investigator:
          • Tanvir Ahmad
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Recruiting
        • Central Washington Health Services Association d/b/a Confluence Health
        • Principal Investigator:
          • Anton Grasch
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • Exemplar Research
        • Principal Investigator:
          • WARD PAINE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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)

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D)
  • 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 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
  • Have a prior or planned surgical treatment for obesity
  • Have New York Heart Association Functional Classification IV congestive heart failure
  • Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart 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 a clinically 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 multiple endocrine 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retatrutide Dose Level 1
Participants will receive retatrutide administered subcutaneously (SC).
Drug: Retatrutide
Administered SC.
Other Names:
  • LY3437943
Experimental: Retatrutide Dose Level 2
Participants will receive retatrutide administered SC.
Drug: Retatrutide
Administered SC.
Other Names:
  • LY3437943
Active Comparator: Semaglutide
Participants will receive semaglutide administered SC.
Drug: Semaglutide
Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time Frame: Baseline, Week 80
Baseline, Week 80

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in HbA1c (%)
Time Frame: Baseline, Week 80
Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time Frame: Week 80
Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Time Frame: Week 80
Week 80
Percent Change from Baseline in Body Weight
Time Frame: Week 80
Week 80
Change from Baseline in Body Weight
Time Frame: Baseline, Week 80
Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time Frame: Week 80
Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time Frame: Week 80
Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time Frame: Week 80
Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time Frame: Week 80
Week 80
Percent Change from Baseline in Triglycerides
Time Frame: Week 80
Week 80
Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
Time Frame: Week 80
Week 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

December 11, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18805
  • J1I-MC-GZBZ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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