A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
ATTAIN-OA PAIN
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
6 other identifiers
interventional
800
7 countries
88
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
October 2, 2026
October 1, 2026
2.5 years
September 2, 2025
October 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Baseline, Week 72
Secondary Outcomes (17)
Change from Baseline in the WOMAC Physical Function Subscale Score
Baseline, Week 72
Percent Change from Baseline in Body Weight
Baseline, Week 72
Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Baseline, Week 72
Change from Baseline in Distance Walked During the 6-Minute Walk Test
Baseline, Week 72
Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)
Baseline, Week 72
- +12 more secondary outcomes
Study Arms (4)
Orforglipron (GZT1)
EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZT1)
PLACEBO COMPARATORParticipants will receive placebo orally
Orforglipron (GZT2)
EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZT2)
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have gained or lost more than 11 pounds within 90 days prior to screening
- Have had a surgery for obesity or plan to have one in the next 18 months
- Have an active knee infection
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure
- Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Arizona Research Center
Phoenix, Arizona, 85053, United States
AMR Clinical
Tempe, Arizona, 85281, United States
Care Access - Huntington Beach
Huntington Beach, California, 92648, United States
Care Access - Thousand Oaks
Thousand Oaks, California, 91360, United States
Legacy Clinical Trials
Colorado Springs, Colorado, 80909, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Care Access - Decatur
Decatur, Georgia, 30030, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwestern University
Chicago, Illinois, 60611, United States
AMR Clinical
Newton, Kansas, 67114, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
AMR Clinical
Kansas City, Missouri, 64114, United States
Cardio Metabolic Institute
Somerset, New Jersey, 08873, United States
Carolina Research Center
Shelby, North Carolina, 28150, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
Care Access - Rapid City
Rapid City, South Dakota, 57701, United States
AMR Clinical
Knoxville, Tennessee, 37909, United States
Mercy Family Clinic
Dallas, Texas, 75208, United States
Juno Research
Houston, Texas, 77040, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Activian Clinical Research
Kingwood, Texas, 77339, United States
Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas, 77382, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Gershon Pain Specialists
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Aggarwal and Associates Limited
Brampton, L6T 0G1, Canada
Diex Recherche Inc. Division Joliette
Joliette, J6E 6A9, Canada
Your Research Network
Niagara Falls, L2H 1H5, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, G1V 4K5, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Winterberry Research Inc.
Stoney Creek, L8J 0B6, Canada
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, 014010, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
The Second Affiliated Hospital Chongqing Medical University
Chongqing, 400010, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, 150001, China
The Second People's Hospital of Hefei
Hefei, 230011, China
Jinan Central Hospital
Jinan, 250013, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003, China
Nanjing First Hospital
Nanjing, 210006, China
Jiangsu Province Hospital
Nanjing, 210029, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, 211100, China
Pingxiang People's Hospital
Pingxiang, 337055, China
The First Hospital of Qinhuangdao
Qinhuangdao Shi, 066000, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, 515041, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
Siteworks GmbH - Bochum
Bochum, 44787, Germany
Klinische Forschung Dresden
Dresden, 01069, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, 20095, Germany
Klinische Forschung Hamburg
Hamburg, 20253, Germany
Pratia - Hannover
Hanover, 30159, Germany
Siteworks GmbH - Hannover
Hanover, 30449, Germany
Klinische Forschung Karlsruhe
Karlsruhe, 76137, Germany
Siteworks - Karlsruhe
Karlsruhe, 76137, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
CDG Studienambulanz Hartard
München, 80809, Germany
Dedicated Research Site FutureMeds
Offenbach, 63065, Germany
Private Practice - Dr. Jochen Walter
Rendsburg, 24768, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97074, Germany
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
Fukuoka Wajiro Hospital
Fukuoka, 811-0213, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Kariya Toyota General Hospital
Kariya, 448-8505, Japan
Ando Orthopedic
Kawasaki, 213-0001, Japan
Tokyo Saiseikai Central Hospital
Minatoku, 108-0073, Japan
Goto Orthopedic Surgery Clinic
Miyazaki, 880-0835, Japan
Kato Orthopedic Clinic
Morioka, 020-0021, Japan
Japan Community Health Care Organization - Saitama Medical Center
Saitama, 330-0074, Japan
Sapporo Maruyama Orthopedic Hospital
Sapporo, 060-0007, Japan
Masumoto Orthopedics Clinic
Suginami City, 167-0051, Japan
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440, Mexico
Centro Medico del Angel
Mexicali, 21100, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070, Mexico
IMED Internal Medicine Clin Trials
Monterrey, 64020, Mexico
Clínica García Flores SC
Monterrey, 64610, Mexico
Hospital San Rafael - La Coruña
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Quirón Málaga
Málaga, 29004, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Clínica Gaias - Santiago
Santiago de Compostela, 15702, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47010, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2025
First Posted
September 4, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
October 2, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.