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Diabetes Type 2Phase 3NCT06354660

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)

A Phase 3 study testing Retatrutide in people with Diabetes Type 2, run by Eli Lilly and Company at 48 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Type 2
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
537 participants
Where
48 sitesin 4 countries
Study dates
10 Apr 2024to 20 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

48 sites in 4 countries.

48 sites in 4 countries

United States29 sites

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304

  • Delricht Research - Tobias Gadson Boulevard - Charleston

    Charleston, South Carolina, 29407

  • MultiCare Rockwood Cheney Clinic

    Cheney, Washington, 99004

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio, 45439

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Northeast Research Institute (NERI)

    Fleming Island, Florida, 32003

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas, 75028

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas, 76164

  • NJ MedCare & NJ Heart

    Linden, New Jersey, 07036

  • Ark Clinical Research

    Long Beach, California, 90815

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Trinity Research Centers

    Marietta, Georgia, 30064

  • Lifedoc Research - Lenox Park Drive

    Memphis, Tennessee, 38115

  • New Horizon Research Center

    Miami, Florida, 33165

  • Ezy Medical Research

    Miami, Florida, 33175

  • Boeson Research MSO

    Missoula, Montana, 59804

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Eastside Research Associates

    Redmond, Washington, 98052

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Tucson Clinical Research Institute

    Tucson, Arizona, 85712

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina, 28401

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Mexico9 sites

  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad

    Guadalajara, Jalisco, 04460

  • EME RED Hospitalaria

    Mérida, Yucatán, 97000

  • Medical Care and Research SA de CV

    Mérida, Yucatán, 97070

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14080

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León, 64460

  • Clínica García Flores SC

    Monterrey, Nuevo León, 64610

  • Grupo Ollin Care

    Pachuca, Hidalgo, 42000

  • Centro de investigación y control metabólico

    San Nicolás de los Garza, Nuevo León, 66465

  • Arké SMO S.A de C.V

    Veracruz, 91910

Other trials in Mexico

India8 sites

  • Gujarat Endocrin Pvt Ltd

    Ahmedabad, Gujarat, 380052

  • Victoria Hospital, Bangalore Medical College And Research Institute

    Bangalore, Karnataka, 560002

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019

  • Eternal Heart Care Center and Research Institute

    Jaipur, Rajasthan, 302020

  • Brij Medical Centre Private Limited

    Kanpur, Uttar Pradesh, 208020

  • Government Medical College - Kozhikode

    Kozhikode, Kerala, 673008

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh, 492099

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat, 395002

Other trials in India

Puerto Rico2 sites

  • Dorado Medical Complex

    Dorado, 00646

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Diabetes Type 2
Being tested
Retatrutide, Placebo
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC.

  • PlaceboDrug

    Administered SC.

Study groups in NCT06354660
Study groupRoleWhat they receive
Retatrutide Dose Level 1ExperimentalParticipants will receive retatrutide administered subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose Level 2ExperimentalParticipants will receive retatrutide administered SC.
Receives: Drug: Retatrutide
Retatrutide Dose Level 3ExperimentalParticipants will receive retatrutide administered SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Hemoglobin A1c (HbA1c) (%)

    Measured: Baseline, Week 40

Secondary outcomes (13)

  1. Percentage of Participants Who Achieve HbA1c < 7.0%

    Measured: Week 40

  2. Percentage of Participants Who Achieve HbA1c ≤ 6.5%

    Measured: Week 40

  3. Percentage of Participants Who Achieve HbA1c < 5.7%

    Measured: Week 40

  4. Change from Baseline in Fasting Serum Glucose

    Measured: Baseline, Week 40

  5. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 40

  6. Change from Baseline in Body Weight

    Measured: Baseline, Week 40

  7. Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

    Measured: Week 40

  8. Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

    Measured: Week 40

  9. Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

    Measured: Week 40

  10. Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction

    Measured: Week 40

  11. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 40

  12. Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol

    Measured: Baseline, Week 40

  13. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start10 Apr 2024
  3. Primary completion22 Jan 2026
  4. Study completion20 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06354660
Sponsor's protocol ID
18804
Other IDs
J1I-MC-GZBY
Status last verified
Mar 2026
First submitted
3 Apr 2024
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bajaj HS, Welch M, Shah P, Luna E, Jaouimaa FZ, Liu B, Liu R, Chen Y, Patel H, Bartee A. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. 2026 Jun 13;407(10546):2402-2413. doi: 10.1016/S0140-6736(26)00967-0. Epub 2026 Jun 6.

    PubMed 42250575

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Diabetes Type 2, run by Eli Lilly and Company at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Mexico, India, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hemoglobin A1c (HbA1c) (%) (time frame: Baseline, Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06354660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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