Recruiting
Phase 3

Orforglipron

Sponsor:

Eli Lilly and Company

Code:

NCT07153471

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

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.

Conditions

Osteoarthritis

Study ID

NCT07153471

Start date

Sep 15, 2025

Status verified date

Sep, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [ Time Frame: Baseline, Week 72 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Contacts

602-863-6363

Principal Investigator:

Louise Taber MD

AMR Clinical

Recruiting

Tempe, Arizona, United States, 85281

Contacts

602-910-3343

Principal Investigator:

William Reedy

Care Access - Huntington Beach

Recruiting

Huntington Beach, California, United States, 92648

Contacts

714-378-2440

Principal Investigator:

Christine Thai

Care Access - Thousand Oaks

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

805-778-5143

Principal Investigator:

Elvira Lindwall

Legacy Clinical Trials

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

719-387-7572

Principal Investigator:

Charles Bird

Chase Medical Research, LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

203-419-4420

Principal Investigator:

Joseph Soufer

Care Access - Decatur

Recruiting

Decatur, Georgia, United States, 30030

Contacts

678-470-4394

Principal Investigator:

Marie Walton

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

312-503-2315

Principal Investigator:

Thomas Schnitzer

AMR Clinical

Recruiting

Newton, Kansas, United States, 67114

Contacts

316-804-7304

Principal Investigator:

Troy Holdeman

MedVadis Research Corporation

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

617-744-1310

Principal Investigator:

David DiBenedetto

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Contacts

636-387-5100

Principal Investigator:

Timothy Smith

AMR Clinical

Recruiting

Kansas City, Missouri, United States, 64114

Principal Investigator:

Martha Fanning

Cardio Metabolic Institute

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

732-846-7000 x 108

Principal Investigator:

Dinesh Singal

Carolina Research Center

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

704-600-6052

Principal Investigator:

Stephen Jones

University Orthopedics Center

Recruiting

Altoona, Pennsylvania, United States, 16602

Principal Investigator:

Joshua Greenleaf

Care Access - Rapid City

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

877-791-0656

Principal Investigator:

Ali Bajwa

AMR Clinical

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

865-305-9100

Principal Investigator:

Jerry Punch

Mercy Family Clinic

Recruiting

Dallas, Texas, United States, 75208

Contacts

281-944-3610

Principal Investigator:

Ebere Israel Azubuike, MD

Juno Research

Recruiting

Houston, Texas, United States, 77040

Contacts

713-779-5494

Principal Investigator:

Damaris Vega

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77084

Contacts

281-944-3610

Principal Investigator:

Kiran Farheen, MD

Activian Clinical Research

Recruiting

Kingwood, Texas, United States, 77339

Contacts

832-969-3401

Principal Investigator:

Martin Basaldua

Advanced Rheumatology of Houston - Woodlands

Recruiting

The Woodlands, Texas, United States, 77382

Contacts

936-681-4882

Principal Investigator:

Tamar Brionez

Charlottesville Medical Research

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

434-817-2442

Principal Investigator:

James Clark

Gershon Pain Specialists

Recruiting

Virginia Beach, Virginia, United States, 23454

Contacts

757-496-2050

Principal Investigator:

Steven Gershon

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Principal Investigator:

Jeena Vaid

Aggarwal and Associates Limited

Recruiting

Brampton, Canada, L6T 0G1

Contacts

9054589033

Principal Investigator:

Naresh Aggarwal

Diex Recherche Inc. Division Joliette

Recruiting

Joliette, Canada, J6E 6A9

Contacts

450-755-2525

Principal Investigator:

Jean-Sebastien Paquette

Your Research Network

Recruiting

Niagara Falls, Canada, L2H 1H5

Principal Investigator:

Mondeesh Sidhu

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

Recruiting

Québec, Canada, G1V 4K5

Contacts

418 650-2661

Principal Investigator:

Louis Bessette

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J 0C4

Principal Investigator:

Nancy Labrecque

ALPHA Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

Contacts

418-847-1112

Principal Investigator:

Xavier Mignault

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Canada, N7T 4X3

Contacts

1 (519) 344-6612

Principal Investigator:

John O'Mahony

Winterberry Research Inc.

Recruiting

Stoney Creek, Canada, L8J 0B6

Contacts

365-366-6267

Principal Investigator:

Steven Zizzo

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-08.