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Recruiting NCT07153471

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

Phase III Interventional Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orforglipron, Placebo.
Who it may be relevant to
Registry conditions: Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, China, Germany, India +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Orforglipron
    Administered orally
  • Drug Placebo
    Administered orally

Primary outcome measures

  • Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Time frame: Baseline, Week 72]
Secondary outcome measures (12)
  • Change from Baseline in the WOMAC Physical Function Subscale Score [Time frame: Baseline, Week 72]
  • Percent Change from Baseline in Body Weight [Time frame: 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]
  • Change from Baseline in Distance Walked During the 6-Minute Walk Test [Time frame: Baseline, Week 72]
  • Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP) [Time frame: Baseline, Week 72]
  • Change from Baseline in Waist Circumference [Time frame: Baseline, Week 72]
  • Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha [Time frame: Baseline, Week 72]
  • Change from Baseline in WOMAC Stiffness Subscale [Time frame: Baseline, Week 72]
  • Change from Baseline in WOMAC Total Score [Time frame: Baseline, Week 72]
  • Change from Baseline in SF-36v2 Acute Form Domain Scores [Time frame: 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]
  • Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain [Time frame: Baseline, Week 72]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • Arizona Research Center — Phoenix
  • AMR Clinical — Tempe
  • Care Access - Huntington Beach — Huntington Beach
  • Care Access - Thousand Oaks — Thousand Oaks
  • Legacy Clinical Trials — Colorado Springs
  • Chase Medical Research, LLC — Waterbury
  • Care Access - Decatur — Decatur
  • North Georgia Clinical Research — Woodstock
  • … and 18 more centers
China · 16 centers
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Scie — Baotou
  • Xuanwu Hospital Capital Medical University — Beijing
  • The Second Affiliated Hospital Chongqing Medical University — Chongqing
  • The Fourth Affiliated Hospital of Harbin Medical University — Harbin
  • The Second People's Hospital of Hefei — Hefei
  • Jinan Central Hospital — Jinan
  • The First Affiliated Hospital of Henan University of Science &Technology — Luoyang
  • Nanjing First Hospital — Nanjing
  • … and 8 more centers
Germany · 14 centers
  • Klinische Forschung Berlin-Mitte — Berlin
  • Siteworks GmbH - Bochum — Bochum
  • Klinische Forschung Dresden — Dresden
  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin — Hamburg
  • Klinische Forschung Hamburg — Hamburg
  • Klinische Forschung Hannover-Mitte — Hanover
  • Siteworks GmbH - Hannover — Hanover
  • Klinische Forschung Karlsruhe — Karlsruhe
  • … and 6 more centers
Japan · 11 centers
  • Hamanomachi Hospital — Fukuoka
  • Fukuoka Wajiro Hospital — Fukuoka
  • Shimane University Hospital — Izumo
  • Kariya Toyota General Hospital — Kariya
  • Ando Orthopedic — Kawasaki
  • Tokyo Saiseikai Central Hospital — Minatoku
  • Goto Orthopedic Surgery Clinic — Miyazaki
  • Kato Orthopedic Clinic — Morioka
  • … and 3 more centers
Canada · 9 centers
  • Aggarwal and Associates Limited — Brampton
  • Diex Recherche Inc. Division Joliette — Joliette
  • Your Research Network — Niagara Falls
  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. — Québec
  • Alpha Recherche Clinique — Québec
  • ALPHA Recherche Clinique — Québec
  • Bluewater Clinical Research Group Inc. — Sarnia
  • Winterberry Research Inc. — Stoney Creek
  • … and 1 more center
Spain · 8 centers

Center list to be confirmed — check the primary protocol.

India · 6 centers
  • All India Institute of Medical Sciences — Bhubaneswar
  • Rajiv Gandhi Government General Hospital — Chennai
  • Atmaram Child Care — Kanpur
  • Kims Kingsway Hospital — Nagpur
  • Maulana Azad Medical College and Associated with Lok Nayak Hospital — New Delhi
  • Vencer Hospital — Pimpri-Chinchwad
Mexico · 6 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07153471 · 27633 · 2025-522631-34-00 · J2A-MC-GZPT · J2A-MC-GZT1 · J2A-MC-GZT2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗