Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

Summary

The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.

Eligibility

Study design

Outcome measures

1. Primary outcome

   Percent Change from Baseline in Body Weight

   Percent Change from Baseline in Body Weight

   Time frame Baseline, Week 64

2. Primary outcome

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

   Change from Baseline in the WOMAC Pain Subscale Score

   Time frame Baseline, Week 64

3. Secondary outcome

   Change from Baseline in Systolic Blood Pressure (SBP)

   Change from Baseline in SBP

   Time frame Baseline, Week 64

4. Secondary outcome

   Percent Change from Baseline in Triglycerides

   Percent Change in Baseline in Triglycerides

   Time frame Baseline, Week 64

5. Secondary outcome

   Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score

   Change from Baseline in SF-36 v2 Score

   Time frame Baseline, Week 64

6. Secondary outcome

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

   Percent Change from Baseline in hsCRP

   Time frame Baseline, Week 64

7. Secondary outcome

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Time frame Baseline, Week 40, Week 64

8. Secondary outcome

   Change from Baseline WOMAC Pain Subscale Score

   Change from Baseline WOMAC Pain Subscale Score

   Time frame Baseline, Week 40

9. Secondary outcome

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

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

   Time frame Baseline, Week 64

10. Secondary outcome

    Change from Baseline in Body Mass Index (BMI)

    Change from Baseline in BMI

    Time frame Baseline, Week 64

11. Secondary outcome

    Change in Medication Use

    Change in Medication Use

    Time frame Baseline, Week 64

12. Secondary outcome

    Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score

    Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score

    Time frame Baseline, Week 64

13. Secondary outcome

    Change from Baseline in Health Status EQ-5D-5L Health State Utility

    Change from Baseline in Health Status EQ-5D-5L Health State Utility

    Time frame Baseline, Week 64

14. Secondary outcome

    Percent Change from Baseline in Fasting Insulin

    Percent Change from Baseline in Fasting Insulin

    Time frame Baseline, Week 64

15. Secondary outcome

    Percent Change from Baseline in Total Cholesterol

    Percent Change from Baseline in Total Cholesterol

    Time frame Baseline, Week 64

16. Secondary outcome

    Change from Baseline in Waist Circumference

    Change from Baseline in Waist Circumference

    Time frame Baseline, Week 64

17. Secondary outcome

    Percent Change from Baseline in Hemoglobin A1c (HbA1c)

    Percent Change from Baseline in HbA1c

    Time frame Baseline, Week 64

18. Secondary outcome

    Change from Baseline in WOMAC Stiffness Subscale Score

    Change from Baseline in WOMAC Stiffness Subscale Score

    Time frame Baseline, Week 64

19. Secondary outcome

    Change from Baseline in WOMAC Total Score

    Change from Baseline in WOMAC Total Score

    Time frame Baseline, Week 64

20. Secondary outcome

    Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain

    Achievement of Improved Categorical Shift in PGIS - Target Knee Pain

    Time frame Baseline, Week 64

21. Secondary outcome

    Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function

    Achievement of Improved Categorical Shift in PGIS - Target Knee Function

    Time frame Baseline, Week 64

22. Secondary outcome

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

    Change from Baseline in API-NRS Score

    Time frame Baseline, Week 64

23. Secondary outcome

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

    Change from Baseline in WPI-NRS Score

    Time frame Baseline, Week 64

24. Secondary outcome

    Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss)

    PK: Cmax, ss

    Time frame Baseline through Week 64

25. Secondary outcome

    PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss)

    PK: AUC(0-T)ss

    Time frame Baseline through Week 64

26. Secondary outcome

    Number of Participants with Allowed Concomitant Pain Medication

    Number of Participants with Allowed Concomitant Pain Medication

    Time frame Baseline, Week 64

Dates

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

126 sites are recruiting

102 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

1. August 6, 2026

   Site removed

   9 sites removed (152 total)

   161 → 152