NCT07153471ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
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
In brief
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…
Phase 3800 participants sought88 sites7 countries
Categories
Registered in 1 registry
- ClinicalTrials.govNCT07153471Open this record at ClinicalTrials.govSynced 2 weeks ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-09-04; recorded start 2025-09-15
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 347 other studies in this databaseCounted from the lead sponsor named in the record (Eli Lilly and Company)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding7/20
Single-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 95 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 800 participants (target), run at 88 sites, across 7 countries.
How this score is built
- Enrolment29/40
800 participants (target)
- Site count22/25
95 sites
- Country count12/15
8 countries
- Planned duration8/10
Planned over about 32 months
- Sponsor scale9/10
Eli Lilly and Company has led 326 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Phase 3 |
| Allocation | Randomised |
| Intervention model | PARALLEL |
| Primary purpose | TREATMENT |
| Masking | SINGLE (1) |
| Enrolment | 800 participants sought |
Sponsor and collaborators
- Eli Lilly and Company Sponsor
Arms and interventions
- Orforglipron (GZT1)EXPERIMENTAL
Participants will receive orforglipron orally
- Placebo (GZT1)PLACEBO_COMPARATOR
Participants will receive placebo orally
- Orforglipron (GZT2)EXPERIMENTAL
Participants will receive orforglipron orally
- Placebo (GZT2)PLACEBO_COMPARATOR
Participants will receive placebo orally
Interventions
- Drug Orforglipron
Administered orally
- Drug Placebo
Administered orally
Outcome measures
Primary outcome
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in the WOMAC Physical Function Subscale Score
Time frame Baseline, Week 72
Secondary outcome
Percent Change from Baseline in Body Weight
Time frame Baseline, Week 72
Secondary outcome
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
Secondary outcome
Change from Baseline in Distance Walked During the 6-Minute Walk Test
Time frame Baseline, Week 72
Secondary outcome
Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in Waist Circumference
Time frame Baseline, Week 72
Secondary outcome
Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in WOMAC Stiffness Subscale
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in WOMAC Total Score
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in SF-36v2 Acute Form Domain Scores
With exception of the Physical Functioning Domain Score
Time frame Baseline, Week 72
Secondary outcome
Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function
Time frame Baseline, Week 72
Secondary outcome
Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score
Time frame Baseline, Week 72
Secondary outcome
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score
Time frame Baseline, Week 72
Secondary outcome
Number of Participants with Allowed Concomitant Pain Medication
Time frame Baseline, Week 72
Secondary outcome
Percent Change from Baseline in Total Cholesterol
Time frame Baseline, Week 72
Secondary outcome
Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron
Time frame Predose through Week 48
Dates
| Start date | September 15, 2025 (actual) |
|---|---|
| Primary completion | April 1, 2028 (estimated) |
| Completion | May 1, 2028 (estimated) |
| First posted | September 4, 2025 (actual) |
| Last updated | September 8, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | September 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
67 sites are recruiting
Canada
| Facility | City | State or region | Status |
|---|---|---|---|
| Aggarwal and Associates Limited | Brampton | Recruiting | |
| Diex Recherche Inc. Division Joliette | Joliette | Recruiting | |
| Your Research Network | Niagara Falls | Recruiting | |
| ALPHA Recherche Clinique | Québec | Recruiting | |
| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. | Québec | Recruiting | |
| Alpha Recherche Clinique | Québec | Recruiting | |
| Bluewater Clinical Research Group Inc. | Sarnia | Recruiting | |
| Winterberry Research Inc. | Stoney Creek | Recruiting |
China
| Facility | City | State or region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T | Baotou | Recruiting | |
| Xuanwu Hospital Capital Medical University | Beijing | Recruiting | |
| The Second Affiliated Hospital Chongqing Medical University | Chongqing | Recruiting | |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Recruiting | |
| The Second People's Hospital of Hefei | Hefei | Recruiting | |
| Jinan Central Hospital | Jinan | Recruiting | |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Recruiting | |
| Nanjing First Hospital | Nanjing | Recruiting | |
| Jiangsu Province Hospital | Nanjing | Recruiting | |
| Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Recruiting | |
| Pingxiang People's Hospital | Pingxiang | Recruiting | |
| The First Hospital of Qinhuangdao | Qinhuangdao Shi | Recruiting | |
| Huashan Hospital, Fudan University | Shanghai | Recruiting | |
| The First Affiliated Hospital of Shantou University Medical College | Shantou | Recruiting | |
| The University of Hong Kong-Shenzhen Hospital | Shenzhen | Recruiting | |
| Taizhou Hospital of Zhejiang Province | Taizhou | Recruiting |
Germany
| Facility | City | State or region | Status |
|---|---|---|---|
| Siteworks GmbH - Bochum | Bochum | Active, not recruiting | |
| Klinische Forschung Dresden | Dresden | Active, not recruiting | |
| HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T | Hamburg | Active, not recruiting | |
| Klinische Forschung Hamburg | Hamburg | Active, not recruiting | |
| Klinische Forschung Hannover-Mitte | Hanover | Active, not recruiting | |
| Siteworks GmbH - Hannover | Hanover | Active, not recruiting | |
| Klinische Forschung Karlsruhe | Karlsruhe | Active, not recruiting | |
| Siteworks - Karlsruhe | Karlsruhe | Active, not recruiting | |
| AmBeNet GmbH | Leipzig | Active, not recruiting | |
| CDG Studienambulanz Hartard | München | Active, not recruiting | |
| Dedicated Research Site FutureMeds | Offenbach | Active, not recruiting | |
| Private Practice - Dr. Jochen Walter | Rendsburg | Active, not recruiting | |
| Universitaetsklinikum Wuerzburg | Würzburg | Active, not recruiting |
Japan
| Facility | City | State or region | Status |
|---|---|---|---|
| Hamanomachi Hospital | Fukuoka | Recruiting | |
| Fukuoka Wajiro Hospital | Fukuoka | Recruiting | |
| Shimane University Hospital | Izumo | Recruiting | |
| Kariya Toyota General Hospital | Kariya | Recruiting | |
| Ando Orthopedic | Kawasaki | Recruiting | |
| Tokyo Saiseikai Central Hospital | Minatoku | Recruiting | |
| Goto Orthopedic Surgery Clinic | Miyazaki | Recruiting | |
| Kato Orthopedic Clinic | Morioka | Recruiting | |
| Japan Community Health Care Organization - Saitama Medical Center | Saitama | Recruiting | |
| Sapporo Maruyama Orthopedic Hospital | Sapporo | Recruiting | |
| Masumoto Orthopedics Clinic | Suginami City | Recruiting |
Mexico
| Facility | City | State or region | Status |
|---|---|---|---|
| Investigacion y Biomedicina de Chihuahua | Chihuahua City | Recruiting | |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. | Ciudad Madero | Recruiting |
38 further sites are listed in the registry record.
Study documents
No documents are linked in this registry record.
Changes over time
- September 8, 2026
Site removed
8 sites removed (88 total)
9688
- August 6, 2026
Site added
1 site added (96 total)
9596