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

NCT ID: NCT07153471

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Arthritis Overnutrition Nutrition Disorder Joint Diseases Musculoskeletal Disease Knee Degeneration Osteoarthrosis Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Orforglipron (GZT1)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Placebo (GZT1)

Participants will receive placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Orforglipron (GZT2)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Placebo (GZT2)

Participants will receive placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Orforglipron

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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(LY3502970)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Arizona Research Center

Phoenix, Arizona, United States

Site Status RECRUITING

AMR Clinical

Tempe, Arizona, United States

Site Status RECRUITING

Care Access - Huntington Beach

Huntington Beach, California, United States

Site Status RECRUITING

Care Access - Thousand Oaks

Thousand Oaks, California, United States

Site Status RECRUITING

Legacy Clinical Trials

Colorado Springs, Colorado, United States

Site Status RECRUITING

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status RECRUITING

Care Access - Decatur

Decatur, Georgia, United States

Site Status RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

AMR Clinical

Newton, Kansas, United States

Site Status RECRUITING

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status RECRUITING

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status RECRUITING

AMR Clinical

Kansas City, Missouri, United States

Site Status RECRUITING

Cardio Metabolic Institute

Somerset, New Jersey, United States

Site Status NOT_YET_RECRUITING

Carolina Research Center

Shelby, North Carolina, United States

Site Status RECRUITING

University Orthopedics Center

Altoona, Pennsylvania, United States

Site Status RECRUITING

Care Access - Rapid City

Rapid City, South Dakota, United States

Site Status RECRUITING

AMR Clinical

Knoxville, Tennessee, United States

Site Status RECRUITING

Mercy Family Clinic

Dallas, Texas, United States

Site Status RECRUITING

Juno Research

Houston, Texas, United States

Site Status RECRUITING

Biopharma Informatic, LLC

Houston, Texas, United States

Site Status RECRUITING

Activian Clinical Research

Kingwood, Texas, United States

Site Status RECRUITING

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States

Site Status RECRUITING

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status RECRUITING

Gershon Pain Specialists

Virginia Beach, Virginia, United States

Site Status RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status RECRUITING

Aggarwal and Associates Limited

Brampton, , Canada

Site Status RECRUITING

Winterberry Research Inc.

Hamilton, , Canada

Site Status RECRUITING

Diex Recherche Inc. Division Joliette

Joliette, , Canada

Site Status RECRUITING

Your Research Network

Niagara Falls, , Canada

Site Status RECRUITING

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

Québec, , Canada

Site Status NOT_YET_RECRUITING

Alpha Recherche Clinique

Québec, , Canada

Site Status RECRUITING

ALPHA Recherche Clinique

Québec, , Canada

Site Status RECRUITING

Bluewater Clinical Research Group Inc.

Sarnia, , Canada

Site Status RECRUITING

Dr. M.B. Jones Inc.

Victoria, , Canada

Site Status NOT_YET_RECRUITING

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

Baotou, , China

Site Status NOT_YET_RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital Chongqing Medical University

Chongqing, , China

Site Status NOT_YET_RECRUITING

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status NOT_YET_RECRUITING

The Second People's Hospital of Hefei

Hefei, , China

Site Status RECRUITING

Jinan Central Hospital

Jinan, , China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, , China

Site Status NOT_YET_RECRUITING

Jiangsu Province Hospital

Nanjing, , China

Site Status NOT_YET_RECRUITING

Pingxiang People's Hospital

Pingxiang, , China

Site Status NOT_YET_RECRUITING

Huashan Hospital, Fudan University

Shanghai, , China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, , China

Site Status RECRUITING

The University of Hong Kong-Shenzhen Hospital

Shenzhen, , China

Site Status NOT_YET_RECRUITING

Klinische Forschung Berlin-Mitte

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Siteworks GmbH - Bochum

Bochum, , Germany

Site Status NOT_YET_RECRUITING

Klinische Forschung Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

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

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Klinische Forschung Hamburg

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Klinische Forschung Hannover-Mitte

Hanover, , Germany

Site Status NOT_YET_RECRUITING

Siteworks GmbH - Hannover

Hanover, , Germany

Site Status NOT_YET_RECRUITING

Siteworks GmbH - Heidelberg

Heidelberg, , Germany

Site Status NOT_YET_RECRUITING

Klinische Forschung Karlsruhe

Karlsruhe, , Germany

Site Status NOT_YET_RECRUITING

AmBeNet GmbH

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

CDG Studienambulanz Hartard

München, , Germany

Site Status NOT_YET_RECRUITING

Dedicated Research Site FutureMeds

Offenbach, , Germany

Site Status NOT_YET_RECRUITING

Private Practice - Dr. Jochen Walter

Rendsburg, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status NOT_YET_RECRUITING

All India Institute of Medical Sciences

Bhubaneswar, , India

Site Status NOT_YET_RECRUITING

Rajiv Gandhi Government General Hospital

Chennai, , India

Site Status NOT_YET_RECRUITING

Atmaram Child Care

Kanpur, , India

Site Status NOT_YET_RECRUITING

Kims Kingsway Hospital

Nagpur, , India

Site Status NOT_YET_RECRUITING

Maulana Azad Medical College and Associated with Lok Nayak Hospital

New Delhi, , India

Site Status NOT_YET_RECRUITING

Vencer Hospital

Pimpri-Chinchwad, , India

Site Status NOT_YET_RECRUITING

Hamanomachi Hospital

Fukuoka, , Japan

Site Status NOT_YET_RECRUITING

Fukuoka Wajiro Hospital

Fukuoka, , Japan

Site Status RECRUITING

Shimane University Hospital

Izumo, , Japan

Site Status NOT_YET_RECRUITING

Kariya Toyota General Hospital

Kariya, , Japan

Site Status NOT_YET_RECRUITING

Ando Orthopedic

Kawasaki, , Japan

Site Status RECRUITING

Tokyo Saiseikai Central Hospital

Minatoku, , Japan

Site Status NOT_YET_RECRUITING

Goto Orthopedic Surgery Clinic

Miyazaki, , Japan

Site Status NOT_YET_RECRUITING

Kato Orthopedic Clinic

Morioka, , Japan

Site Status RECRUITING

Japan Community Health Care Organization - Saitama Medical Center

Saitama, , Japan

Site Status RECRUITING

Sapporo Maruyama Orthopedic Hospital

Sapporo, , Japan

Site Status RECRUITING

Masumoto Orthopedics Clinic

Suginami City, , Japan

Site Status NOT_YET_RECRUITING

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Site Status NOT_YET_RECRUITING

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

Ciudad Madero, , Mexico

Site Status NOT_YET_RECRUITING

Centro Medico del Angel

Mexicali, , Mexico

Site Status NOT_YET_RECRUITING

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

Mérida, , Mexico

Site Status NOT_YET_RECRUITING

IMED Internal Medicine Clin Trials

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Clínica García Flores SC

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Hospital San Rafael - La Coruña

A Coruña, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Quirón Málaga

Málaga, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status NOT_YET_RECRUITING

Clínica Gaias - Santiago

Santiago de Compostela, , Spain

Site Status NOT_YET_RECRUITING

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, , Spain

Site Status NOT_YET_RECRUITING

Hospital Quiron Infanta Luisa

Seville, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Canada China Germany India Japan Mexico Spain

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Related Links

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https://trials.lilly.com/en-US/trial/648295

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

Other Identifiers

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2025-522631-34-00

Identifier Type: CTIS

Identifier Source: secondary_id

J2A-MC-GZPT

Identifier Type: OTHER

Identifier Source: secondary_id

J2A-MC-GZT1

Identifier Type: OTHER

Identifier Source: secondary_id

J2A-MC-GZT2

Identifier Type: OTHER

Identifier Source: secondary_id

27633

Identifier Type: -

Identifier Source: org_study_id