Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around
Principal Investigator
by Dianne Cheung

Description

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.

Official Title

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor

Keywords

Type 2 Diabetes, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Kidney Disease, Renal Insufficiency Chronic, Type 2 Diabetes Mellitus, Retatrutide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCLA South Bay Endocrinology accepting new patients
    Torrance California 90505 United States
  • Diabetes and Endocrine Associates not yet accepting patients
    La Mesa California 91942 United States
  • Clinical Research Institute of Arizona (CRI) - Sun City West accepting new patients
    Sun City West Arizona 85375 United States

Lead Scientist at UCLA

  • Dianne Cheung
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
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)
ID
NCT06297603
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 320 study participants
Last Updated