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)

Phase 3

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Retatrutide; Drug: Placebo

• Registration Number: NCT06297603
• Lead Sponsor: Eli Lilly and Company

Brief 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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Study Start: 2024-03-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retatrutide Dose 2	Retatrutide	Participants will receive retatrutide administered SC.
Retatrutide Dose 3	Retatrutide	Participants will receive retatrutide administered SC.
Retatrutide Dose 1	Retatrutide	Participants will receive retatrutide administered subcutaneously (SC).
Placebo	Placebo	Participants will receive placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c) (%)	Baseline, Week 52

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HbA1c <7.0%	Week 52
Percentage of Participants Achieving HbA1c ≤6.5%	Week 52
Change from Baseline in Fasting Serum Glucose	Baseline, Week 52
Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL	Week 52	Measured during the CGM session that occurs during 30 days prior to Week 52
Percent Change from Baseline in Body Weight	Baseline, Week 52
Change from Baseline in Body Weight	Baseline, Week 52
Percentage of Participants Achieving Weight Reduction of ≥5%	Week 52
Percentage of Participants Achieving Weight Reduction of ≥10%	Week 52
Percentage of Participants Achieving Weight Reduction of ≥15%	Week 52
Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction	Week 52
Percent Change from Baseline in Non-HDL Cholesterol	Baseline, Week 52
Percent Change from Baseline in Triglycerides	Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 52

Trial Locations

Locations (78)

Nephrology Consultants; 🇺🇸 Huntsville, Alabama, United States

Clinical Research Institute of Arizona (CRI) - Sun City West; 🇺🇸 Sun City West, Arizona, United States

Kidney & Hypertension Center - Apple Valley; 🇺🇸 Apple Valley, California, United States

Hope Clinical Research, Inc.; 🇺🇸 Canoga Park, California, United States

Neighborhood Healthcare Institute of Health; 🇺🇸 Escondido, California, United States

EndoTrials Center for Clinical Research; 🇺🇸 La Mesa, California, United States

UCLA South Bay Endocrinology; 🇺🇸 Torrance, California, United States

Northeast Research Institute (NERI); 🇺🇸 Fleming Island, Florida, United States

Encore Medical Research - Weston; 🇺🇸 Weston, Florida, United States

Orita Clinical Research; 🇺🇸 Decatur, Georgia, United States

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