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Clinical Trials in the USA / NCT06297603
Active, not recruiting Phase 3

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)

NCT06297603 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-03-15
Last updated
2026-07-20

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

RetatrutidePlacebo

Retatrutide: Administered SC

Placebo: Administered SC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (76)

FacilityCityRegionStatus
Nephrology Consultants Huntsville Alabama
Clinical Research Institute of Arizona (CRI) - Sun City West Sun City West Arizona
Kidney & Hypertension Center - Apple Valley Apple Valley California
Hope Clinical Research, Inc. Canoga Park California
Neighborhood Healthcare Institute of Health Escondido California
EndoTrials Center for Clinical Research La Mesa California
UCLA South Bay Endocrinology Torrance California
Northeast Research Institute (NERI) Fleming Island Florida
Encore Medical Research - Weston Weston Florida
Orita Clinical Research Decatur Georgia
CARE Institute Idaho Falls Idaho
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas
Billings Clinic Billings Montana
Excel Clinical Research, LLC Las Vegas Nevada
Albany Medical College, Division of Community Endocrinology Albany New York
NYC Research INC Long Island City New York
Research Foundation of SUNY - University of Buffalo Williamsville New York
University of North Carolina Medical Center Chapel Hill North Carolina
Central States Research Tulsa Oklahoma
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania
AM Diabetes & Endocrinology Center Bartlett Tennessee
Velocity Clinical Research, Dallas Dallas Texas
Prime Revival Research Institute, LLC Flower Mound Texas
Juno Research Houston Texas
PlanIt Research, PLLC Houston Texas
Southern Endocrinology Associates Mesquite Texas
Texas Valley Clinical Research Weslaco Texas
Diabetes & Endocrine Treatment Specialists Sandy City Utah
Investigaciones Medicas Imoba Srl Buenos Aires Argentina
Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina
CIPREC Buenos Aires Argentina
CIPREC Buenos Aires Argentina
Centro Médico Viamonte Buenos Aires Argentina
Mautalen Salud e Investigación Buenos Aires Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Buenos Aires Argentina
CEDIC CABA Argentina
Centro Diabetológico Dr. Waitman Córdoba Argentina
Centro Médico Colón Córdoba Argentina
Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Argentina
CIMeL Lanus Argentina

+ 36 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06297603 on ClinicalTrials.gov ↗ ← All trials in the USA