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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT06297603

Run by

Eli Lilly and Company

People needed

320

Starts

2024-03-15

Expected to finish

2026-11-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• CARE Institute — Idaho Falls, Idaho, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• Billings Clinic — Billings, Montana, United States
• Excel Clinical Research, LLC — Las Vegas, Nevada, United States
• Albany Medical College, Division of Community Endocrinology — Albany, New York, United States
• NYC Research INC — Long Island City, New York, United States
• Research Foundation of SUNY - University of Buffalo — Williamsville, New York, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Central States Research — Tulsa, Oklahoma, United States
• Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair — Pittsburgh, Pennsylvania, United States
• AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States
• Velocity Clinical Research, Dallas — Dallas, Texas, United States
• Prime Revival Research Institute, LLC — Flower Mound, Texas, United States
• Juno Research — Houston, Texas, United States
• PlanIt Research, PLLC — Houston, Texas, United States
• Nephrology Consultants — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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