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)

March 3, 2026 updated by: Eli Lilly and Company

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 and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

537

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 Locations

  • India
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492099
        • All India Institute of Medical Sciences
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Gujarat Endocrin Pvt Ltd
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College - Kozhikode
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • All India Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, India, 302020
        • Eternal Heart Care Center and Research Institute
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208020
        • Brij Medical Centre Private Limited
  • Mexico
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42000
        • Grupo Ollin Care
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 04460
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Unidad Biomedica Avanzada Monterrey
      • Monterrey, Nuevo León, Mexico, 64610
        • Clínica García Flores SC
      • San Nicolás de los Garza, Nuevo León, Mexico, 66465
        • Centro de investigación y control metabólico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • EME RED Hospitalaria
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care and Research Sa de Cv
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Clinical Trials
      • Tucson, Arizona, United States, 85712
        • Tucson Clinical Research Institute
    • California
      • Canoga Park, California, United States, 91304
        • San Fernando Valley Health Institute
      • Long Beach, California, United States, 90815
        • ARK Clinical Research
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute (NERI)
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Miami, Florida, United States, 33175
        • Ezy Medical Research
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida
    • Georgia
      • Marietta, Georgia, United States, 30064
        • Trinity Research Centers
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research MSO
    • New Jersey
      • Linden, New Jersey, United States, 07036
        • NJ MedCare & NJ Heart
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare - Wilmington - 1917 Tradd Court
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners-Center for Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Delricht Research - Tobias Gadson Boulevard - Charleston
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • Lifedoc Research - Lenox Park Drive
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates Inc
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Flower Mound, Texas, United States, 75028
        • Prime Revival Research Institute, LLC
      • Fort Worth, Texas, United States, 76164
        • Valley Institute of Research - Fort Worth
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
      • Weslaco, Texas, United States, 78596
        • Texas Valley Clinical Research
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
    • Washington
      • Cheney, Washington, United States, 99004
        • MultiCare Rockwood Cheney Clinic
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates

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% 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 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) <15 milliliters/minute/1.73 meter 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 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: Double

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
Placebo Comparator: Placebo
Participants will receive placebo administered SC.
Drug: Placebo
Administered SC.
Experimental: Retatrutide Dose Level 3
Participants will receive retatrutide administered SC.
Drug: Retatrutide
Administered SC.
Other Names:
  • LY3437943

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieve HbA1c < 7.0%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieve HbA1c < 5.7%
Time Frame: Week 40
Week 40
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time Frame: Week 40
Week 40
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 40
Baseline, Week 40
Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline, Week 40
Baseline, Week 40

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

April 10, 2024

Primary Completion (Actual)

January 22, 2026

Study Completion (Actual)

February 20, 2026

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18804
  • J1I-MC-GZBY (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

product manufactured in and exported from the U.S.

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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