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: Active_not_recruiting
Location: See all (76) 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
Huntsville
Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West
California
Kidney & Hypertension Center - Apple Valley
Apple Valley
Hope Clinical Research, Inc.
Canoga Park
Neighborhood Healthcare Institute of Health
Escondido
EndoTrials Center for Clinical Research
La Mesa
UCLA South Bay Endocrinology
Torrance
Florida
Northeast Research Institute (NERI)
Fleming Island
Encore Medical Research - Weston
Weston
Georgia
Orita Clinical Research
Decatur
Idaho
CARE Institute
Idaho Falls
Kansas
Cotton O'Neil Diabetes & Endocrinology
Topeka
Montana
Billings Clinic
Billings
North Carolina
University of North Carolina Medical Center
Chapel Hill
Nevada
Excel Clinical Research, LLC
Las Vegas
New York
Albany Medical College, Division of Community Endocrinology
Albany
NYC Research INC
Long Island City
Research Foundation of SUNY - University of Buffalo
Williamsville
Oklahoma
Central States Research
Tulsa
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh
Tennessee
AM Diabetes & Endocrinology Center
Bartlett
Texas
Velocity Clinical Research, Dallas
Dallas
Prime Revival Research Institute, LLC
Flower Mound
Juno Research
Houston
PlanIt Research, PLLC
Houston
Southern Endocrinology Associates
Mesquite
Texas Valley Clinical Research
Weslaco
Utah
Diabetes & Endocrine Treatment Specialists
Sandy City
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Centro Médico Viamonte
Buenos Aires
CIPREC
Buenos Aires
CIPREC
Buenos Aires
Investigaciones Medicas Imoba Srl
Buenos Aires
Mautalen Salud e Investigación
Buenos Aires
CEDIC
Caba
Centro Diabetológico Dr. Waitman
Córdoba
Centro Médico Colón
Córdoba
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria
CIMeL
Lanús
Centro de Investigaciones Médicas Mar del Plata
Mar Del Plata
DIM Clínica Privada
Ramos Mejía
INECO Neurociencias Oroño
Rosario
Instituto de Investigaciones Clinicas Rosario
Rosario
Instituto Médico Catamarca IMEC
Rosario
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario
Brazil
Centro de Diabetes Curitiba
Curitiba
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio De Janeiro
Praxis Pesquisa Medica
Santo André
Instituto de Pesquisa Clinica
São Paulo
CEDOES
Vitória
Israel
Clalit Health Services - Atlit
Atlit
Soroka Medical Center
Beersheba
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya
Edith Wolfson Medical Center
Holon
Hadassah Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan
Clalit Health Services - Sakhnin Community Clinic
Sakhnin
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City
Diseno y Planeacion en Investigacion Medica
Guadalajara
Medical Care and Research SA de CV
Mérida
FAICIC S. de R.L. de C.V.
Veracruz
Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
Bayamón
Isis Clinical Research Center
Guaynabo
Mgcendo Llc
San Juan
United Kingdom
Southmead Hospital
Bristol
Edinburgh Royal Infirmary
Edinburgh
Panthera Biopartners - Glasgow
Glasgow
George Eliot Hospital
Nuneaton
Panthera Biopartners - Preston
Preston
Panthera Biopartners - Manchester
Rochdale
Salford Royal Hospital
Salford
Lister Hospital
Stevenage
The Royal Cornwall Hospital
Truro
Time Frame
Start Date: 2024-03-15
Completion Date: 2026-11
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