Active not recruitingPhase 3

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

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, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Estimated enrollment

320

Study population

Renal impairment, Type 2 diabetes

Eligibility highlights

•BMI ≥23•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06297603

Org study ID18806

Secondary IDJ1I-MC-GZQAEli Lilly and Company

Timeline

Milestones

Study first posted2024-03-07actual

Study start2024-03-15actual

Last update posted2025-12-24actual

Primary completion2026-10estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Investigational agents

Retatrutide

Who this study enrolls

Renal impairmentType 2 diabetes

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 moderate or severe renal impairment

•Have been on the following stable diabetes treatment during 90 days prior to screening

-basal insulin (≥20 International Units (IU)/day) with or without

-metformin and/or SGLT2 inhibitor

•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/m2)

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 a history of unstable or rapidly progressing renal disease

•Have a prior or planned surgical treatment for obesity

•Have New York Heart Association Functional Classification III or IV congestive heart failure

•Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.

•Have any lifetime history of a suicide attempt

•Had chronic or acute pancreatitis

•Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening

Endpoints (14)

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

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Reduction of ≥5%

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Reduction of ≥10%

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Reduction of ≥15%

Time frame:Week 52

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL

Time frame:Week 52

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

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

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Non-HDL Cholesterol

Time frame:Baseline, Week 52

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 52

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.