A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial
Status: Active_not_recruiting
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
• Have Type 2 Diabetes (T2D)
• Are on stable treatment for T2D for at least 90 days
• Have a history of at least one unsuccessful dietary effort to lose body weight.
⁃ GSA2 Inclusion Criteria
• Previously diagnosed with OSA
• Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
• For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
• If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
Locations
United States
Alabama
Pinnacle Research Group, LLC
Anniston
Cullman Clinical Trials
Cullman
Arkansas
Preferred Research Partners
Little Rock
California
Core Healthcare Group
Cerritos
Velocity Clinical Research, Westlake
Los Angeles
Valley Clinical Trials, Inc.
Northridge
Diablo Clinical Research, Inc.
Walnut Creek
Connecticut
Chase Medical Research, LLC
Waterbury
Florida
Excel Medical Clinical Trials
Boca Raton
Teradan Clinical Trials, LLC
Brandon
Fleming Island Center for Clinical Research
Fleming Island
Therafirst Medical Center
Fort Lauderdale
Clinical Site Partners LLC, dba Flourish Research
Miami
Quantum Clinical Trials
Miami Beach
Renstar Medical Research
Ocala
Clinical Research Center of Florida
Pompano Beach
Palm Beach Research Center
West Palm Beach
Clinical Site Partners, LLC dba Flourish Research
Winter Park
Georgia
NeuroTrials Research Inc
Atlanta
Centricity Research Rincon Pulmonology
Rincon
Hawaii
East-West Medical Research Institute
Honolulu
Indiana
Brengle Family Medicine
Indianapolis
Massachusetts
MedVadis Research Corporation
Waltham
Missouri
StudyMetrix Research
City Of Saint Peters
North Carolina
Monroe Biomedical Research
Monroe
Carteret Medical Group
Morehead City
North Dakota
Lillestol Research
Fargo
Nevada
Las Vegas Medical Research
Las Vegas
New York
Mid Hudson Medical Research
New Windsor
Ohio
CTI Clinical Research Center
Cincinnati
Intrepid Research
Cincinnati
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh
Preferred Primary Care Physicians
Uniontown
South Carolina
Tribe Clinical Research, LLC
Greenville
Trial Management Associates
Myrtle Beach
Tribe Clinical Research - Spartanburg
Spartanburg
Texas
FutureSearch Trials of Neurology
Austin
Velocity Clinical Research, Dallas
Dallas
Utah
Advanced Research Institute
Ogden
Washington
Northwest Clinical Research Center
Bellevue
Other Locations
Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Centro Médico Viamonte
Buenos Aires
Consultorio de Investigación Clínica EMO SRL
Buenos Aires
Centro de Salud e Investigaciones Médicas
Santa Rosa
Australia
Nightingale Research
Adelaide
Flinders University
Bedford Park
Emeritus Research
Botany
Box Hill Hospital
Box Hill
Core Research Group
Brisbane
Royal Brisbane and Women's Hospital
Brisbane
Emeritus Research
Camberwell
Austin Health - Repatriation Hospital
Heidelberg West
Advara HeartCare Joondalup
Joondalup
Woolcock Institute of Medical Research
Macquarie Park
The AIM Centre / Hunter Diabetes Centre
Merewether
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park
Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo
CEPIC - Centro Paulista de Investigação Clínica
São Paulo
CPQuali Pesquisa Clínica
São Paulo
India
Avron Hospitals
Ahmedabad
V.S. General Hospital
Ahmedabad
Zydus Hospitals & Healthcare Research Pvt.Ltd.
Ahmedabad
Life Care Hospital and Research Centre
Bangalore
Madras Diabetes Research Foundation
Chennai
Sushruta Multispeciality Hospital & Research Centre
Hubli
Care Hospitals Hyderabad- Banjara Hills
Hyderabad
Diabetes Research Center
Hyderabad
CARE CHL-Hospitals
Indore
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata
Mysore Medical College
Mysore
All India Institute of Medical Sciences
Raipur
Christian Medical College Vellore
Vellore
Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City
Diseno y Planeacion en Investigacion Medica
Guadalajara
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City
Clinica Omega
Mexico City
RM Pharma Specialists
Mexico City
Cardiolink Clin Trials
Monterrey
Unidad biomedica avanzada monterrey
Monterrey
Arké SMO S.A de C.V
Veracruz
FAICIC S. de R.L. de C.V.
Veracruz
Romania
CMI Dr.Pletea Noemi SRL
Bacau
Centrul Medical NutriLife
Bucharest
Geea Medical Easy Diet
Bucharest
Gama Diamed
Mangalia
Diabdana
Oradea
Centrul Medical Mediab
Târgu Mureş
Spain
Centro Periférico de Especialidades Bola Azul
Almería
Complejo Asistencial Universitario de León - Hospital de León
León
Hospital Universitario Ramón y Cajal
Madrid
H.R.U Málaga - Hospital Civil
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Virgen Del Rocio
Seville
Vithas Hospital Sevilla
Seville
Time Frame
Start Date: 2023-07-11
Completion Date: 2026-05
Participants
Target number of participants: 1000
Treatments
Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC).
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC.
Experimental: Retatrutide Dose 3
Participants will receive retatrutide SC.
Placebo_comparator: Placebo
Participants will receive placebo.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company