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)

Description

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.

Conditions

Type 2 Diabetes

Study Overview

Study Details

Study 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.

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

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)

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Huntsville

Nephrology Consultants, Huntsville, Alabama, United States, 35805

Sun City West

Clinical Research Institute of Arizona (CRI) - Sun City West, Sun City West, Arizona, United States, 85375

Escondido

Neighborhood Healthcare Institute of Health, Escondido, California, United States, 92025

La Mesa

EndoTrials Center for Clinical Research, La Mesa, California, United States, 91942

Torrance

UCLA South Bay Endocrinology, Torrance, California, United States, 90505

Fleming Island

Northeast Research Institute (NERI), Fleming Island, Florida, United States, 32003

Decatur

Orita Clinical Research, Decatur, Georgia, United States, 30034

Idaho Falls

Care Research, Idaho Falls, Idaho, United States, 83404

Topeka

Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, United States, 66606

Billings

Billings Clinic, Billings, Montana, United States, 59101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-10