Osteoarthritis
Conditions
Keywords
Arthritis, Overnutrition, Nutrition Disorder, Joint Diseases, Musculoskeletal Disease, Knee Degeneration, Osteoarthrosis, Obese
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.
Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Baseline, Week 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score | Baseline, Week 72 | — |
| Number of Participants with Allowed Concomitant Pain Medication | Baseline, Week 72 | — |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 72 | — |
| Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron | Predose through Week 48 | — |
| Change from Baseline in SF-36v2 Acute Form Domain Scores | Baseline, Week 72 | With exception of the Physical Functioning Domain Score |
| Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function | Baseline, Week 72 | — |
| Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain | Baseline, Week 72 | — |
| Change from Baseline in the WOMAC Physical Function Subscale Score | Baseline, Week 72 | — |
| Percent Change from Baseline in Body Weight | Baseline, Week 72 | — |
| Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | Baseline, Week 72 | — |
| Change from Baseline in Distance Walked During the 6-Minute Walk Test | Baseline, Week 72 | — |
| Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP) | Baseline, Week 72 | — |
| Change from Baseline in Waist Circumference | Baseline, Week 72 | — |
| Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha | Baseline, Week 72 | — |
| Change from Baseline in WOMAC Stiffness Subscale | Baseline, Week 72 | — |
| Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score | Baseline, Week 72 | — |
| Change from Baseline in WOMAC Total Score | Baseline, Week 72 | — |
Countries
Canada, China, Germany, Japan, Mexico, Spain, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed