ATTAIN-OA PAIN

RecruitingPhase 3

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

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

800

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

—

Primary endpoint

•WOMAC pain

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07153471

Org study ID27633

Secondary ID2025-522631-34-00

Secondary IDJ2A-MC-GZPTEli Lilly and Company

Secondary IDJ2A-MC-GZT1Eli Lilly and Company

Secondary IDJ2A-MC-GZT2Eli Lilly and Company

Timeline

Milestones

Study first posted2025-09-04actual

Study start2025-09-15actual

Last update posted2026-05-22actual

Primary completion2028-04estimated (month precision)

Study completion2028-05estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Heart failure

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Heart failure

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Distance Walked During the 6-Minute Walk Test

Time frame:Baseline, Week 72

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)

Time frame:Baseline, Week 72

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

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

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in SF-36v2 Acute Form Domain Scores

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function

Time frame:Baseline, Week 72

PGI, change

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain

Time frame:Baseline, Week 72

PGI, change

threshold achievement, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants with Allowed Concomitant Pain Medication

Time frame:Baseline, Week 72

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

Time frame:Predose through Week 48

AUC₀–∞

concentration, descriptive

Other clinical outcomes

6 endpoints

Primary/protocol endpoint

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Time frame:Baseline, Week 72

WOMAC pain

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the WOMAC Physical Function Subscale Score

Time frame:Baseline, Week 72

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in WOMAC Stiffness Subscale

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in WOMAC Total Score

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score

Time frame:Baseline, Week 72

WOMAC pain

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha

Time frame:Baseline, Week 72

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.