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)

Overview

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.

Eligibility

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