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)

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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