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NCT Number: NCT07153471

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

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.

Recruiting

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Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aggarwal and Associates Limited, Brampton, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: (LY3502970)

Placebo

Drug

Administered orally

Primary outcomes

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

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Change from Baseline in the WOMAC Physical Function Subscale Score

    Time frame: Baseline, Week 72

  2. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

  3. 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

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  6. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  8. Change from Baseline in WOMAC Stiffness Subscale

    Time frame: Baseline, Week 72

  9. Change from Baseline in WOMAC Total Score

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

    With exception of the Physical Functioning Domain Score

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  15. Number of Participants with Allowed Concomitant Pain Medication

    Time frame: Baseline, Week 72

  16. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 72

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

    Time frame: Predose through Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: ATTAIN-OA PAIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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