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Diabetes Mellitus, Type 2Phase 3NCT06260722

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)

A Phase 3 study testing Retatrutide and Semaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 77 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Retatrutide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,250 participants
Where
77 sitesin 5 countries
Study dates
21 Feb 2024to Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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% (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)

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) <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
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

77 sites in 5 countries.

77 sites in 5 countries

United States38 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Alabama - Department of Nutrition Sciences

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital Diabetes Program

    Boston, Massachusetts, 02115

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117

  • Neighborhood Healthcare Institute of Health

    Escondido, California, 92025

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas, 76164

  • Medication Management

    Greensboro, North Carolina, 27405

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96817

  • Juno Research

    Houston, Texas, 77040

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

    Hyattsville, Maryland, 20782

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • Long Beach Research Institute

    Long Beach, California, 90805

  • NYC Research INC

    Long Island City, New York, 11106

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • South Broward Research

    Miramar, Florida, 33027

  • IMA Clinical Research Monroe - Armand

    Monroe, Louisiana, 71201

  • IMA Clinical Research West Virginia

    Morgantown, West Virginia, 26505

  • Deaconess Clinic - Gateway Health Center

    Newburgh, Indiana, 47630

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Herman Clinical Research

    Suwanee, Georgia, 30024

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Central States Research

    Tulsa, Oklahoma, 74136

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

    Wenatchee, Washington, 98801

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Medrasa Clinical Research

    Wylie, Texas, 75098

Other trials in United States

Argentina15 sites

  • Stat Research S.A.

    Buenos Aires, Buenos Aires F.D., C1023AAB

  • CIPREC

    Buenos Aires, Buenos Aires F.D., C1061AAS

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC

  • Mautalen Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • CEMEDIAB

    C.a.b.a., Buenos Aires F.D., C1205AAO

  • Instituto Centenario

    CABA, Buenos Aires F.D., 1204

  • CARE - Centro de Alergia y Enfermedades Respiratorias

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1414

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, Córdoba Province, 5006

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza Province, 5501

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe Province, 2152

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe Province, S2000CVD

Other trials in Argentina

Canada12 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • University of Calgary - Clinical Trials Unit

    Calgary, Alberta, T2T 5C7

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1

  • Winterberry Research Inc.

    Hamilton, Ontario, L8J 0B6

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario, L8L 5G8

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L5G4

  • 9109-0126 Quebec Inc.

    Montreal, Quebec, H4N 2W2

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Prime Health Clinical Research

    Toronto, Ontario, M4S 1Y2

  • Maple Leaf Research

    Toronto, Ontario, M5G 1K2

  • Private Practice - Dr. Nigel Jagan

    Whitby, Ontario, L1N 2L1

Other trials in Canada

Mexico10 sites

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos, 62250

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco, 44130

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100

  • Hospital de Jésus, I.A.P.

    Mexico City, Mexico City, 06090

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

    Mexico City, Mexico City, 11650

  • Cardiolink Clin Trials

    Monterrey, Nuevo León, 64060

  • Clínica García Flores SC

    Monterrey, Nuevo León, 64610

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851

Other trials in Mexico

Puerto Rico2 sites

  • Advanced Clinical Research, LLC

    Bayamón, 00959

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Retatrutide, Semaglutide
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Incretins
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.

  • SemaglutideDrug

    Administered SC.

Study groups in NCT06260722
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
SemaglutideActive comparatorParticipants will receive semaglutide administered SC.
Receives: Drug: Semaglutide

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 80

Secondary outcomes (12)

  1. Change from Baseline in HbA1c (%)

    Measured: Baseline, Week 80

  2. Percentage of Participants Who Achieve HbA1c ≤ 6.5%

    Measured: Week 80

  3. Percentage of Participants Who Achieve HbA1c < 5.7%

    Measured: Week 80

  4. Percent Change from Baseline in Body Weight

    Measured: Week 80

  5. Change from Baseline in Body Weight

    Measured: Baseline, Week 80

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

    Measured: Week 80

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

    Measured: Week 80

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

    Measured: Week 80

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

    Measured: Week 80

  10. Percent Change from Baseline in Triglycerides

    Measured: Week 80

  11. Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol

    Measured: Week 80

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

    Measured: Baseline, Week 80

Timeline

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

  1. First posted15 Feb 2024
  2. Study start21 Feb 2024
  3. Primary completion27 Aug 2026
  4. Study completionFeb 2027 (estimated)

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
None (open label)
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260722
Sponsor's protocol ID
18805
Other IDs
J1I-MC-GZBZ
Status last verified
Sep 2026
First submitted
8 Feb 2024
Last updated
28 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide and Semaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 77 sites in 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Argentina, Canada, Mexico, 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. 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?

This study is still under way. Results are not available in the source record yet.

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 80). 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 NCT06260722.

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 28 Sep 2026.

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