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.
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
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
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- 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
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
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
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
Puerto Rico2 sites
Advanced Clinical Research, LLC
Bayamón, 00959
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
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.
- Conditions
- Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| Retatrutide Dose Level 1 | Experimental | Participants will receive retatrutide administered subcutaneously (SC). Receives: Drug: Retatrutide |
| Retatrutide Dose Level 2 | Experimental | Participants will receive retatrutide administered SC. Receives: Drug: Retatrutide |
| Semaglutide | Active comparator | Participants 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.
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Measured: Baseline, Week 80
Secondary outcomes (12)
Change from Baseline in HbA1c (%)
Measured: Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Measured: Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Measured: Week 80
Percent Change from Baseline in Body Weight
Measured: Week 80
Change from Baseline in Body Weight
Measured: Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Measured: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Measured: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Measured: Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Measured: Week 80
Percent Change from Baseline in Triglycerides
Measured: Week 80
Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
Measured: Week 80
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.
- First posted15 Feb 2024
- Study start21 Feb 2024
- Primary completion27 Aug 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
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.