Open
Actively Recruiting
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
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
23-5264
Category
Endocrine and Metabolic Disorders
Principal Investigator
Contact
Location
- UCLA Torrance
- UCLA Westwood