RecruitingPhase 3NCT07153471

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

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


Sponsor

Eli Lilly and Company

Enrollment

800 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally


Locations(94)

Arizona Research Center

Phoenix, Arizona, United States

AMR Clinical

Tempe, Arizona, United States

Care Access - Huntington Beach

Huntington Beach, California, United States

Care Access - Thousand Oaks

Thousand Oaks, California, United States

Legacy Clinical Trials

Colorado Springs, Colorado, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Care Access - Decatur

Decatur, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Northwestern University

Chicago, Illinois, United States

AMR Clinical

Newton, Kansas, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

AMR Clinical

Kansas City, Missouri, United States

Cardio Metabolic Institute

Somerset, New Jersey, United States

Carolina Research Center

Shelby, North Carolina, United States

University Orthopedics Center

Altoona, Pennsylvania, United States

Care Access - Rapid City

Rapid City, South Dakota, United States

AMR Clinical

Knoxville, Tennessee, United States

Mercy Family Clinic

Dallas, Texas, United States

Juno Research

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Activian Clinical Research

Kingwood, Texas, United States

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Gershon Pain Specialists

Virginia Beach, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Aggarwal and Associates Limited

Brampton, Canada

Diex Recherche Inc. Division Joliette

Joliette, Canada

Your Research Network

Niagara Falls, Canada

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

Québec, Canada

Alpha Recherche Clinique

Québec, Canada

ALPHA Recherche Clinique

Québec, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Winterberry Research Inc.

Stoney Creek, Canada

Dr. M.B. Jones Inc.

Victoria, Canada

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T

Baotou, China

Xuanwu Hospital Capital Medical University

Beijing, China

The Second Affiliated Hospital Chongqing Medical University

Chongqing, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

The Second People's Hospital of Hefei

Hefei, China

Jinan Central Hospital

Jinan, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, China

Jiangsu Province Hospital

Nanjing, China

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, China

Pingxiang People's Hospital

Pingxiang, China

The First Hospital of Qinhuangdao

Qinhuangdao Shi, China

Huashan Hospital, Fudan University

Shanghai, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, China

Klinische Forschung Berlin-Mitte

Berlin, Germany

Siteworks GmbH - Bochum

Bochum, Germany

Klinische Forschung Dresden

Dresden, Germany

HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T

Hamburg, Germany

Klinische Forschung Hamburg

Hamburg, Germany

Klinische Forschung Hannover-Mitte

Hanover, Germany

Siteworks GmbH - Hannover

Hanover, Germany

Klinische Forschung Karlsruhe

Karlsruhe, Germany

Siteworks - Karlsruhe

Karlsruhe, Germany

AmBeNet GmbH

Leipzig, Germany

CDG Studienambulanz Hartard

München, Germany

Dedicated Research Site FutureMeds

Offenbach, Germany

Private Practice - Dr. Jochen Walter

Rendsburg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

All India Institute of Medical Sciences

Bhubaneswar, India

Rajiv Gandhi Government General Hospital

Chennai, India

Atmaram Child Care

Kanpur, India

Kims Kingsway Hospital

Nagpur, India

Maulana Azad Medical College and Associated with Lok Nayak Hospital

New Delhi, India

Vencer Hospital

Pimpri-Chinchwad, India

Hamanomachi Hospital

Fukuoka, Japan

Fukuoka Wajiro Hospital

Fukuoka, Japan

Shimane University Hospital

Izumo, Japan

Kariya Toyota General Hospital

Kariya, Japan

Ando Orthopedic

Kawasaki, Japan

Tokyo Saiseikai Central Hospital

Minatoku, Japan

Goto Orthopedic Surgery Clinic

Miyazaki, Japan

Kato Orthopedic Clinic

Morioka, Japan

Japan Community Health Care Organization - Saitama Medical Center

Saitama, Japan

Sapporo Maruyama Orthopedic Hospital

Sapporo, Japan

Masumoto Orthopedics Clinic

Suginami City, Japan

Investigacion y Biomedicina de Chihuahua

Chihuahua City, Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

Ciudad Madero, Mexico

Centro Medico del Angel

Mexicali, Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Mexico

IMED Internal Medicine Clin Trials

Monterrey, Mexico

Clínica García Flores SC

Monterrey, Mexico

Hospital San Rafael - La Coruña

A Coruña, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Quirón Málaga

Málaga, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Clínica Gaias - Santiago

Santiago de Compostela, Spain

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, Spain

Hospital Quiron Infanta Luisa

Seville, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

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NCT07153471


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