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Active not recruitingPhase 3

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, 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)

Assets

Retatrutide / Semaglutide

Listed sites

77

Recruiting sites

Enrollment

1,250

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥25HbA1c ≥7%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06260722
Org study ID18805
Secondary IDJ1I-MC-GZBZEli Lilly and Company

Timeline

Milestones

Study first posted2024-02-15actual
Study start2024-02-21actual
Last update posted2026-04-13actual
Primary completion2026-08estimated (month precision)
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
5
Glycemic / diabetes
5
Cardiometabolic biomarkers
3

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Week 80

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 80

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

Time frame:Week 80

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

Time frame:Week 80

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

Time frame:Week 80

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

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

Time frame:Baseline, Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in HbA1c (%)

Time frame:Baseline, Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c ≤ 6.5%

Time frame:Week 80

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c < 5.7%

Time frame:Week 80

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 80

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Week 80

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:Week 80

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 80

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.