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)

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Conditions

Type 2 DiabetesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Kidney DiseaseRenal Insufficiency Chronic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-03-15
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06297603

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have Type 2 Diabetes (T2D)
  2. * Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
  3. * Have moderate or severe renal impairment
  4. * Have been on the following stable diabetes treatment during 90 days prior to screening
  5. * basal insulin (≥20 International Units (IU)/day) with or without
  6. * metformin and/or SGLT2 inhibitor
  7. * Are of stable weight for at least 90 days prior to screening
  8. * Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)
  1. * Have Type 1 Diabetes (T1D)
  2. * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
  3. * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
  4. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  5. * Have a history of unstable or rapidly progressing renal disease
  6. * Have a prior or planned surgical treatment for obesity
  7. * Have New York Heart Association Functional Classification III or IV congestive heart failure
  8. * Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
  9. * Have a known clinically significant gastric emptying abnormality
  10. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
  11. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
  12. * Have any lifetime history of a suicide attempt
  13. * Had chronic or acute pancreatitis
  14. * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

Nephrology Consultants
Huntsville, Alabama, 35805
United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375
United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
United States
EndoTrials Center for Clinical Research
La Mesa, California, 91942
United States
UCLA South Bay Endocrinology
Torrance, California, 90505
United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003
United States
Orita Clinical Research
Decatur, Georgia, 30034
United States
Care Research
Idaho Falls, Idaho, 83404
United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
United States
Billings Clinic
Billings, Montana, 59101
United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109
United States
Sierra Nevada Specialty Care
Reno, Nevada, 89511
United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
United States
NYC Research INC
Long Island City, New York, 11106
United States
Research Foundation of SUNY - University of Buffalo
Williamsville, New York, 14221
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
United States
Lucas Research, Inc.
Hickory, North Carolina, 28601
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Central States Research
Tulsa, Oklahoma, 74136
United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243
United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, 75098
United States
Juno Research
Houston, Texas, 77040
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
Diabetes & Endocrine Treatment Specialists
Sandy, Utah, 84093
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-15
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-03-15
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Type 2 Diabetes