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)
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.
- EligibilityCriteria: 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult