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
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alabama
Nephrology Consultants
RECRUITING
Huntsville
Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West
RECRUITING
Sun City West
California
Kidney & Hypertension Center - Apple Valley
RECRUITING
Apple Valley
Hope Clinical Research, Inc.
RECRUITING
Canoga Park
Neighborhood Healthcare Institute of Health
RECRUITING
Escondido
EndoTrials Center for Clinical Research
RECRUITING
La Mesa
UCLA South Bay Endocrinology
RECRUITING
Torrance
Florida
Northeast Research Institute (NERI)
RECRUITING
Fleming Island
Encore Medical Research - Weston
RECRUITING
Weston
Georgia
Orita Clinical Research
RECRUITING
Decatur
Idaho
CARE Institute
RECRUITING
Idaho Falls
Kansas
Cotton O'Neil Diabetes & Endocrinology
RECRUITING
Topeka
Montana
Billings Clinic
RECRUITING
Billings
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Nevada
Excel Clinical Research, LLC
RECRUITING
Las Vegas
New York
Albany Medical College, Division of Community Endocrinology
RECRUITING
Albany
NYC Research INC
RECRUITING
Long Island City
Research Foundation of SUNY - University of Buffalo
RECRUITING
Williamsville
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
Central States Research
RECRUITING
Tulsa
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
RECRUITING
Pittsburgh
Tennessee
AM Diabetes & Endocrinology Center
RECRUITING
Bartlett
Texas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Prime Revival Research Institute, LLC
RECRUITING
Flower Mound
Juno Research
RECRUITING
Houston
PlanIt Research, PLLC
RECRUITING
Houston
Southern Endocrinology Associates
RECRUITING
Mesquite
Texas Valley Clinical Research
RECRUITING
Weslaco
Utah
Diabetes & Endocrine Treatment Specialists
RECRUITING
Sandy City
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
RECRUITING
Buenos Aires
Centro Médico Viamonte
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
Investigaciones Medicas Imoba Srl
RECRUITING
Buenos Aires
Mautalen Salud e Investigación
RECRUITING
Buenos Aires
CEDIC
RECRUITING
Caba
Centro Diabetológico Dr. Waitman
RECRUITING
Córdoba
Centro Médico Colón
RECRUITING
Córdoba
Centro de Investigaciones Clínicas Baigorria
RECRUITING
Granadero Baigorria
CIMeL
RECRUITING
Lanús
Centro de Investigaciones Médicas Mar del Plata
RECRUITING
Mar Del Plata
DIM Clínica Privada
RECRUITING
Ramos Mejía
INECO Neurociencias Oroño
RECRUITING
Rosario
Instituto de Investigaciones Clinicas Rosario
RECRUITING
Rosario
Instituto Médico Catamarca IMEC
RECRUITING
Rosario
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
RECRUITING
Rosario
Brazil
Centro de Diabetes Curitiba
RECRUITING
Curitiba
Instituto de Ensino e Pesquisa Clinica do Ceara
RECRUITING
Fortaleza
Centro de Pesquisas Clínicas Dr. Marco Mota
RECRUITING
Maceió
IBPClin - Instituto Brasil de Pesquisa Clínica
RECRUITING
Rio De Janeiro
Praxis Pesquisa Medica
RECRUITING
Santo André
Instituto de Pesquisa Clinica
RECRUITING
São Paulo
CEDOES
RECRUITING
Vitória
Israel
Clalit Health Services - Atlit
RECRUITING
Atlit
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Institute of Diabetes, Technology and Research - Clalit Health
RECRUITING
Herzliya
Edith Wolfson Medical Center
RECRUITING
Holon
Hadassah Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Clalit Health Services - Sakhnin Community Clinic
RECRUITING
Sakhnin
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
RECRUITING
Chihuahua City
Diseno y Planeacion en Investigacion Medica
RECRUITING
Guadalajara
Medical Care and Research SA de CV
RECRUITING
Mérida
Instituto Nacional de Cardiologia Ignacio Chavez
NOT_YET_RECRUITING
México
FAICIC S. de R.L. de C.V.
RECRUITING
Veracruz
Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
RECRUITING
Bayamón
Isis Clinical Research Center
RECRUITING
Guaynabo
Mgcendo Llc
RECRUITING
San Juan
United Kingdom
Southmead Hospital
RECRUITING
Bristol
Edinburgh Royal Infirmary
RECRUITING
Edinburgh
Panthera Biopartners - Glasgow
RECRUITING
Glasgow
George Eliot Hospital
RECRUITING
Nuneaton
Panthera Biopartners - Preston
RECRUITING
Preston
Panthera Biopartners - Manchester
RECRUITING
Rochdale
Salford Royal Hospital
RECRUITING
Salford
Lister Hospital
RECRUITING
Stevenage
The Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-10
Participants
Target number of participants: 320
Treatments
Experimental: Retatrutide Dose 1
Participants will receive retatrutide administered subcutaneously (SC).
Experimental: Retatrutide Dose 2
Participants will receive retatrutide administered SC.
Experimental: Retatrutide Dose 3
Participants will receive retatrutide administered SC.
Placebo_comparator: Placebo
Participants will receive placebo administered SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company