A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee (ATTAIN-OA PAIN)

June 3, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Canada
      • Brampton, Canada, L6T 0G1
        • Recruiting
        • Aggarwal and Associates Limited
        • Contact:
          • Phone Number: 9054589033
        • Principal Investigator:
          • Naresh Aggarwal
      • Joliette, Canada, J6E 6A9
        • Recruiting
        • Diex Recherche Inc. Division Joliette
        • Principal Investigator:
          • Jean-Sebastien Paquette
        • Contact:
          • Phone Number: 450-755-2525
      • Niagara Falls, Canada, L2H 1H5
        • Recruiting
        • Your Research Network
        • Principal Investigator:
          • Mondeesh Sidhu
      • Québec, Canada, G3K 2P8
        • Recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Xavier Mignault
        • Contact:
          • Phone Number: 418-847-1112
      • Québec, Canada, G2J 0C4
        • Recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Nancy Labrecque
      • Québec, Canada, G1V 3M7
        • Recruiting
        • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
        • Principal Investigator:
          • Louis Bessette
        • Contact:
          • Phone Number: 418 650-2661
      • Sarnia, Canada, N7T 4X3
        • Recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
        • Contact:
          • Phone Number: 1 (519) 344-6612
      • Stoney Creek, Canada, L8J 0B6
        • Recruiting
        • Winterberry Research Inc.
        • Principal Investigator:
          • Steven Zizzo
        • Contact:
          • Phone Number: 365-366-6267
      • Victoria, Canada, V8V 4A1
        • Not yet recruiting
        • Dr. M.B. Jones Inc.
        • Principal Investigator:
          • Michael Jones
        • Contact:
          • Phone Number: 2503833311
  • China
      • Baotou, China, 014010
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
        • Principal Investigator:
          • Yongfu Wang
        • Contact:
          • Phone Number: 8618047211500
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Yi Zhao
      • Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital Chongqing Medical University
        • Principal Investigator:
          • Lin Tang
        • Contact:
          • Phone Number: 02363693222
      • Harbin, China, 150001
        • Recruiting
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
          • Phone Number: 18903602198
        • Principal Investigator:
          • ZhiFeng Cheng
      • Hefei, China, 230011
        • Recruiting
        • The Second People's Hospital of Hefei
        • Principal Investigator:
          • Jun Ye
        • Contact:
          • Phone Number: 86-13956099720
      • Jinan, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Phone Number: 15318816130
        • Principal Investigator:
          • Shuya Guo
      • Luoyang, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Xiaofei Shi
        • Contact:
          • Phone Number: 86 13663884080
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Wenfeng Tan
      • Nanjing, China, 211100
        • Recruiting
        • Nanjing Medical University - Nanjing Jiangning Hospital
        • Principal Investigator:
          • Kun Wang
        • Contact:
          • Phone Number: 025-52105625
      • Pingxiang, China, 337055
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
          • Phone Number: 13879936380
        • Principal Investigator:
          • Jiankang Hu
      • Qinhuangdao Shi, China, 066000
        • Recruiting
        • The First Hospital of Qinhuangdao
        • Principal Investigator:
          • Bowei Liu
        • Contact:
          • Phone Number: 15903366689
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Principal Investigator:
          • Weiguo Wan
        • Contact:
          • Phone Number: 18121186085
      • Shantou, China, 515041
        • Recruiting
        • The First Affiliated Hospital of Shantou University Medical College
        • Contact:
          • Phone Number: 13750428653
        • Principal Investigator:
          • Zhiduo Hou
      • Shenzhen, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital
        • Principal Investigator:
          • Ling Wu
      • Taizhou, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Principal Investigator:
          • Zhenghua Hong
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Klinische Forschung Berlin-Mitte
        • Contact:
          • Phone Number: +49 30 206 580 800
        • Principal Investigator:
          • Hartmut Tischner
      • Bochum, Germany, 44787
        • Recruiting
        • Siteworks GmbH - Bochum
        • Contact:
          • Phone Number: +49 234 60144350
        • Principal Investigator:
          • Annemone Koechel
      • Dresden, Germany, 01069
        • Recruiting
        • Klinische Forschung Dresden
        • Principal Investigator:
          • Peter Heymer
        • Contact:
          • Phone Number: 00493512052780
      • Hamburg, Germany, 20253
        • Recruiting
        • Klinische Forschung Hamburg
        • Contact:
          • Phone Number: 00494046076323
        • Principal Investigator:
          • Marret Mehrwald
      • Hamburg, Germany, 20095
        • Recruiting
        • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
        • Principal Investigator:
          • Andrea Everding
        • Contact:
          • Phone Number: 004940323103166
      • Hanover, Germany, 30159
        • Recruiting
        • Klinische Forschung Hannover-Mitte
        • Principal Investigator:
          • Jan Wagner
        • Contact:
          • Phone Number: +49 511 169 76 50
      • Hanover, Germany, 30449
        • Recruiting
        • Siteworks GmbH - Hannover
        • Contact:
          • Phone Number: +4951151524747
        • Principal Investigator:
          • Ulrike Lengler
      • Karlsruhe, Germany, 76137
        • Recruiting
        • Klinische Forschung Karlsruhe
        • Principal Investigator:
          • Alla Reimer
        • Contact:
          • Phone Number: 0049 721 89 34 926
      • Karlsruhe, Germany, 76137
        • Recruiting
        • Siteworks - Karlsruhe
        • Contact:
          • Phone Number: 004951151524740
        • Principal Investigator:
          • Niels-Christian Hoellger
      • Leipzig, Germany, 04107
        • Recruiting
        • AmBeNet GmbH
        • Contact:
          • Phone Number: 4934196276326
        • Principal Investigator:
          • Hans-Detlev Stahl
      • München, Germany, 80809
        • Recruiting
        • CDG Studienambulanz Hartard
        • Principal Investigator:
          • Manfred Hartard
        • Contact:
          • Phone Number: 00498935819977
      • Offenbach, Germany, 63065
        • Recruiting
        • Dedicated Research Site FutureMeds
        • Principal Investigator:
          • Christel Contzen
        • Contact:
          • Phone Number: 0049 69 247433849
      • Rendsburg, Germany, 24768
        • Recruiting
        • Private Practice - Dr. Jochen Walter
        • Contact:
          • Phone Number: 00494331337660
        • Principal Investigator:
          • Jochen Walter
      • Würzburg, Germany, 97074
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Phone Number: 00499318033575
        • Principal Investigator:
          • Lothar Seefried
  • India
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Contact:
          • Phone Number: 9437182313
        • Principal Investigator:
          • Bishnu Patro
      • Chennai, India, 600003
        • Not yet recruiting
        • Rajiv Gandhi Government General Hospital
        • Principal Investigator:
          • Dr.Senthil Kumar Siva kumar
      • Kanpur, India, 208011
        • Not yet recruiting
        • Atmaram Child Care
        • Principal Investigator:
          • Manish Singh
      • Nagpur, India, 440001
        • Not yet recruiting
        • Kims Kingsway Hospital
        • Principal Investigator:
          • Mukesh Sancheti
      • New Delhi, India, 110002
        • Not yet recruiting
        • Maulana Azad Medical College and Associated with Lok Nayak Hospital
        • Principal Investigator:
          • Sumit Arora
      • Pimpri-Chinchwad, India, 411027
        • Not yet recruiting
        • Vencer Hospital
        • Principal Investigator:
          • Bhushan Shitole
  • Japan
      • Fukuoka, Japan, 811-0213
        • Recruiting
        • Fukuoka Wajiro Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Daiki Okazaki
      • Fukuoka, Japan, 810-8539
        • Recruiting
        • Hamanomachi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Taro Mawatari
      • Izumo, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuji Uchio
      • Kariya, Japan, 448-8505
        • Recruiting
        • Kariya Toyota General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Funahashi
      • Kawasaki, Japan, 213-0001
        • Recruiting
        • Ando Orthopedic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masayo Kato
      • Minatoku, Japan, 108-0073
        • Recruiting
        • Tokyo Saiseikai Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Eri Katsuyama
      • Miyazaki, Japan, 880-0835
        • Recruiting
        • Goto Orthopedic Surgery Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Keisuke Goto
      • Morioka, Japan, 020-0021
        • Recruiting
        • Kato Orthopedic Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • SADAFUMI KATO
      • Saitama, Japan, 330-0074
        • Recruiting
        • Japan Community Health Care Organization - Saitama Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takao Kodama
      • Sapporo, Japan, 060-0007
        • Recruiting
        • Sapporo Maruyama Orthopedic Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Miki Kuroda
      • Suginami City, Japan, 167-0051
        • Recruiting
        • Masumoto Orthopedics Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kou Masumoto
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua
        • Contact:
          • Phone Number: 526144373003
        • Principal Investigator:
          • Cesar Pacheco-Tena
      • Ciudad Madero, Mexico, 89440
        • Recruiting
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
        • Principal Investigator:
          • Rafael Violante Ortiz
        • Contact:
          • Phone Number: 52 1 833 126 00 55
      • Mexicali, Mexico, 21100
        • Recruiting
        • Centro Medico del Angel
        • Contact:
          • Phone Number: 6862262882
        • Principal Investigator:
          • Beatriz Zazueta Montiel
      • Monterrey, Mexico, 64610
        • Recruiting
        • Clínica García Flores SC
        • Contact:
          • Phone Number: 528113578379
        • Principal Investigator:
          • Pedro García Hernández
      • Monterrey, Mexico, 64020
        • Recruiting
        • IMED Internal Medicine Clin Trials
        • Contact:
          • Phone Number: 8183470078
        • Principal Investigator:
          • Jose Garza Ruiz
      • Mérida, Mexico, 97070
        • Recruiting
        • Köhler & Milstein Research S.A. de C.V.
        • Principal Investigator:
          • Jesus Simon Campos
        • Contact:
          • Phone Number: +529999204004
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital San Rafael - La Coruña
        • Contact:
          • Phone Number: 655624017
        • Principal Investigator:
          • Alfonso Soto Gonzalez
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: 34697817352
        • Principal Investigator:
          • ANDREEA CIUDIN
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quirón Málaga
        • Contact:
          • Phone Number: 34684054019
        • Principal Investigator:
          • Jose Garcia Almeida
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Phone Number: 34639659866
        • Principal Investigator:
          • Luis Vazquez Salvi
      • Santiago de Compostela, Spain, 15702
        • Recruiting
        • Clínica Gaias - Santiago
        • Contact:
          • Phone Number: 0034981951018
        • Principal Investigator:
          • Juan Amarelo Ramos
      • Seville, Spain, 41003
        • Recruiting
        • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
        • Principal Investigator:
          • Alberto Aliaga Verdugo
        • Contact:
          • Phone Number: + 34 954709183
      • Seville, Spain, 41010
        • Recruiting
        • Hospital Quiron Infanta Luisa
        • Contact:
          • Phone Number: 670502836
        • Principal Investigator:
          • MARGARITA RIVAS FERNANDEZ
      • Valladolid, Spain, 47010
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Principal Investigator:
          • Daniel De luis roman
        • Contact:
          • Phone Number: 983420000 ext. 86660
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Recruiting
        • Arizona Research Center
        • Contact:
          • Phone Number: 602-863-6363
        • Principal Investigator:
          • Louise Taber MD
      • Tempe, Arizona, United States, 85281
        • Recruiting
        • AMR Clinical
        • Contact:
          • Phone Number: 602-910-3343
        • Principal Investigator:
          • William Reedy
    • California
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Care Access - Huntington Beach
        • Contact:
          • Phone Number: 714-378-2440
        • Principal Investigator:
          • Christine Thai
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Care Access - Thousand Oaks
        • Principal Investigator:
          • Elvira Lindwall
        • Contact:
          • Phone Number: 805-778-5143
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • Legacy Clinical Trials
        • Contact:
          • Phone Number: 719-387-7572
        • Principal Investigator:
          • Charles Bird
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Chase Medical Research, LLC
        • Contact:
          • Phone Number: 203-419-4420
        • Principal Investigator:
          • Joseph Soufer
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Care Access - Decatur
        • Principal Investigator:
          • Marie Walton
        • Contact:
          • Phone Number: 678-470-4394
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 678-494-5735
        • Principal Investigator:
          • Bram Wieskopf
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Phone Number: 312-503-2315
        • Principal Investigator:
          • Thomas Schnitzer
    • Kansas
      • Newton, Kansas, United States, 67114
        • Recruiting
        • AMR Clinical
        • Contact:
          • Phone Number: 316-804-7304
        • Principal Investigator:
          • Troy Holdeman
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Corporation
        • Contact:
          • Phone Number: 617-744-1310
        • Principal Investigator:
          • David DiBenedetto
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • Recruiting
        • StudyMetrix Research
        • Contact:
          • Phone Number: 636-387-5100
        • Principal Investigator:
          • Timothy Smith
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • AMR Clinical
        • Principal Investigator:
          • Martha Fanning
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Recruiting
        • Cardio Metabolic Institute
        • Principal Investigator:
          • Dinesh Singal
        • Contact:
          • Phone Number: 732-846-7000 x 108
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Carolina Research Center
        • Principal Investigator:
          • Stephen Jones
        • Contact:
          • Phone Number: 704-600-6052
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Recruiting
        • University Orthopedics Center
        • Principal Investigator:
          • Joshua Greenleaf
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Care Access - Rapid City
        • Principal Investigator:
          • Ali Bajwa
        • Contact:
          • Phone Number: 877-791-0656
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • AMR Clinical
        • Contact:
          • Phone Number: 865-305-9100
        • Principal Investigator:
          • Jerry Punch
    • Texas
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Mercy Family Clinic
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Ebere Israel Azubuike, MD
      • Houston, Texas, United States, 77084
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Kiran Farheen, MD
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Contact:
          • Phone Number: 713-779-5494
        • Principal Investigator:
          • Damaris Vega
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Activian Clinical Research
        • Principal Investigator:
          • Martin Basaldua
        • Contact:
          • Phone Number: 832-969-3401
      • The Woodlands, Texas, United States, 77382
        • Recruiting
        • Advanced Rheumatology of Houston - Woodlands
        • Principal Investigator:
          • Tamar Brionez
        • Contact:
          • Phone Number: 936-681-4882
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • Charlottesville Medical Research
        • Contact:
          • Phone Number: 434-817-2442
        • Principal Investigator:
          • James Clark
      • Virginia Beach, Virginia, United States, 23454
        • Recruiting
        • Gershon Pain Specialists
        • Contact:
          • Phone Number: 757-496-2050
        • Principal Investigator:
          • Steven Gershon
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Jeena Vaid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orforglipron (GZT1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • (LY3502970)
Placebo Comparator: Placebo (GZT1)
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron (GZT2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • (LY3502970)
Placebo Comparator: Placebo (GZT2)
Participants will receive placebo orally
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in the WOMAC Physical Function Subscale Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Distance Walked During the 6-Minute Walk Test
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in WOMAC Stiffness Subscale
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in WOMAC Total Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in SF-36v2 Acute Form Domain Scores
Time Frame: Baseline, Week 72
With exception of the Physical Functioning Domain Score
Baseline, Week 72
Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants with Allowed Concomitant Pain Medication
Time Frame: Baseline, Week 72
Baseline, Week 72
Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron
Time Frame: Predose through Week 48
Predose through Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27633
  • 2025-522631-34-00 (Ctis)
  • J2A-MC-GZPT (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZT1 (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZT2 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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