A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial
Status: Recruiting
Location: See all (92) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
• Have tried at least once to lose weight through diet but were unsuccessful
• Have osteoarthritis of the knee and at least one of the following conditions:
‣ Be over 50 years old
⁃ Have morning knee stiffness that lasts about 30 minutes
⁃ Have a crackling or grinding sound or feeling in the knee
Locations
United States
Arizona
Arizona Research Center
RECRUITING
Phoenix
AMR Clinical
RECRUITING
Tempe
California
Care Access - Huntington Beach
RECRUITING
Huntington Beach
Care Access - Thousand Oaks
RECRUITING
Thousand Oaks
Colorado
Legacy Clinical Trials
RECRUITING
Colorado Springs
Connecticut
Chase Medical Research, LLC
RECRUITING
Waterbury
Georgia
Care Access - Decatur
RECRUITING
Decatur
North Georgia Clinical Research
RECRUITING
Woodstock
Illinois
Northwestern University
RECRUITING
Chicago
Kansas
AMR Clinical
RECRUITING
Newton
Massachusetts
MedVadis Research Corporation
RECRUITING
Waltham
Missouri
StudyMetrix Research
RECRUITING
City Of Saint Peters
AMR Clinical
RECRUITING
Kansas City
North Carolina
Carolina Research Center
RECRUITING
Shelby
New Jersey
Cardio Metabolic Institute
RECRUITING
Somerset
Pennsylvania
University Orthopedics Center
RECRUITING
Altoona
South Dakota
Care Access - Rapid City
RECRUITING
Rapid City
Tennessee
AMR Clinical
RECRUITING
Knoxville
Texas
Mercy Family Clinic
RECRUITING
Dallas
Biopharma Informatic, LLC
RECRUITING
Houston
Juno Research
RECRUITING
Houston
Activian Clinical Research
RECRUITING
Kingwood
Advanced Rheumatology of Houston - Woodlands
RECRUITING
The Woodlands
Virginia
Charlottesville Medical Research
RECRUITING
Charlottesville
Gershon Pain Specialists
RECRUITING
Virginia Beach
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Canada
Aggarwal and Associates Limited
RECRUITING
Brampton
Diex Recherche Inc. Division Joliette
RECRUITING
Joliette
Your Research Network
RECRUITING
Niagara Falls
Alpha Recherche Clinique
RECRUITING
Québec
ALPHA Recherche Clinique
RECRUITING
Québec
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
RECRUITING
Québec
Bluewater Clinical Research Group Inc.
RECRUITING
Sarnia
Winterberry Research Inc.
RECRUITING
Stoney Creek
Dr. M.B. Jones Inc.
NOT_YET_RECRUITING
Victoria
China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
RECRUITING
Baotou
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
The Second Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
The Fourth Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Second People's Hospital of Hefei
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science &Technology
RECRUITING
Luoyang
Jiangsu Province Hospital
RECRUITING
Nanjing
Pingxiang People's Hospital
RECRUITING
Pingxiang
Huashan Hospital, Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
The University of Hong Kong-Shenzhen Hospital
RECRUITING
Shenzhen
Germany
Klinische Forschung Berlin-Mitte
NOT_YET_RECRUITING
Berlin
Siteworks GmbH - Bochum
RECRUITING
Bochum
Klinische Forschung Dresden
RECRUITING
Dresden
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
RECRUITING
Hamburg
Klinische Forschung Hamburg
RECRUITING
Hamburg
Klinische Forschung Hannover-Mitte
RECRUITING
Hanover
Siteworks GmbH - Hannover
RECRUITING
Hanover
Siteworks GmbH - Heidelberg
RECRUITING
Heidelberg
Klinische Forschung Karlsruhe
NOT_YET_RECRUITING
Karlsruhe
AmBeNet GmbH
RECRUITING
Leipzig
CDG Studienambulanz Hartard
RECRUITING
München
Dedicated Research Site FutureMeds
RECRUITING
Offenbach
Private Practice - Dr. Jochen Walter
RECRUITING
Rendsburg
Universitaetsklinikum Wuerzburg
NOT_YET_RECRUITING
Würzburg
India
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Bhubaneswar
Rajiv Gandhi Government General Hospital
NOT_YET_RECRUITING
Chennai
Atmaram Child Care
NOT_YET_RECRUITING
Kanpur
Kims Kingsway Hospital
NOT_YET_RECRUITING
Nagpur
Maulana Azad Medical College and Associated with Lok Nayak Hospital
NOT_YET_RECRUITING
New Delhi
Vencer Hospital
NOT_YET_RECRUITING
Pimpri-chinchwad
Japan
Fukuoka Wajiro Hospital
RECRUITING
Fukuoka
Hamanomachi Hospital
RECRUITING
Fukuoka
Shimane University Hospital
NOT_YET_RECRUITING
Izumo
Kariya Toyota General Hospital
NOT_YET_RECRUITING
Kariya
Ando Orthopedic
RECRUITING
Kawasaki
Tokyo Saiseikai Central Hospital
RECRUITING
Minatoku
Goto Orthopedic Surgery Clinic
RECRUITING
Miyazaki
Kato Orthopedic Clinic
RECRUITING
Morioka
Japan Community Health Care Organization - Saitama Medical Center
RECRUITING
Saitama
Sapporo Maruyama Orthopedic Hospital
RECRUITING
Sapporo
Masumoto Orthopedics Clinic
RECRUITING
Suginami City
Mexico
Investigacion y Biomedicina de Chihuahua
NOT_YET_RECRUITING
Chihuahua City
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
NOT_YET_RECRUITING
Ciudad Madero
Kohler & Milstein Research S.A. De C.V.
NOT_YET_RECRUITING
Mérida
Centro Medico del Angel
NOT_YET_RECRUITING
Mexicali
Clínica García Flores SC
NOT_YET_RECRUITING
Monterrey
IMED Internal Medicine Clin Trials
NOT_YET_RECRUITING
Monterrey
Spain
Hospital San Rafael - La Coruña
RECRUITING
A Coruña
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Quirón Málaga
RECRUITING
Málaga
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Clínica Gaias - Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
RECRUITING
Seville
Hospital Quiron Infanta Luisa
RECRUITING
Seville
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
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: 2025-09-15
Estimated Completion Date: 2028-05
Participants
Target number of participants: 800
Treatments
Experimental: Orforglipron (GZT1)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (GZT1)
Participants will receive placebo orally
Experimental: Orforglipron (GZT2)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (GZT2)
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company