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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
800
Administered orally
Administered orally
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame: Baseline, Week 72
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
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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With exception of the Physical Functioning Domain Score
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
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score
Time frame: Baseline, Week 72
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score
Time frame: Baseline, Week 72
Number of Participants with Allowed Concomitant Pain Medication
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron
Time frame: Predose through Week 48