A Phase 3 interventional study of Orforglipron and Placebo in Osteoarthritis, sponsored by Eli Lilly and Company. Active, not recruiting at 88 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 800 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have osteoarthritis of the knee and at least one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Administered orally
Also known as: (LY3502970)
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
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
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Sep 2025 (actual). Primary completion is estimated for Apr 2028, 31 months after the start.
Of 60 industry-sponsored phase 3 interventional studies under Osteoarthritis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 22. This study's planned 31 months is above that.
Counting every sponsor, half of 84 studies reached it within 17 months; a quarter within 11 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orforglipron