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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

Short name ATTAIN-OA PAIN

NCTNCT07153471 (opens ClinicalTrials.gov in a new tab)Other id27633Other id2025-522631-34-00Other idJ2A-MC-GZPTOther idJ2A-MC-GZT1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
800 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Single masking
Countries
7 countries

United States, Canada, China, Germany, Japan, Mexico, Spain

Start
15 Sept 2025
Primary completion
Apr 2028 (estimated)
Completion
May 2028 (estimated)
First posted
4 Sept 2025
Last update posted
8 Oct 2026
Conditions
Osteoarthritis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    ATTAIN-OA PAIN

    NCT07153471

    15 Sept 2025 to est. May 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms4

  • Experimental

    Orforglipron (GZT1)

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo (GZT1)

    Participants will receive placebo orally

  • Experimental

    Orforglipron (GZT2)

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo (GZT2)

    Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, Week 72

Secondary outcomes(17)

  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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