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

Sintesi

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.

Idoneità

Disegno dello studio

Esiti misurati

1. Esito primario

   Percent Change from Baseline in Body Weight

   Percent Change from Baseline in Body Weight

   Orizzonte temporale Baseline, Week 64

2. Esito primario

   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

   Orizzonte temporale Baseline, Week 64

3. Esito secondario

   Change from Baseline in Systolic Blood Pressure (SBP)

   Change from Baseline in SBP

   Orizzonte temporale Baseline, Week 64

4. Esito secondario

   Percent Change from Baseline in Triglycerides

   Percent Change in Baseline in Triglycerides

   Orizzonte temporale Baseline, Week 64

5. Esito secondario

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

   Change from Baseline in SF-36 v2 Score

   Orizzonte temporale Baseline, Week 64

6. Esito secondario

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

   Percent Change from Baseline in hsCRP

   Orizzonte temporale Baseline, Week 64

7. Esito secondario

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Orizzonte temporale Baseline, Week 40, Week 64

8. Esito secondario

   Change from Baseline WOMAC Pain Subscale Score

   Change from Baseline WOMAC Pain Subscale Score

   Orizzonte temporale Baseline, Week 40

9. Esito secondario

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

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

   Orizzonte temporale Baseline, Week 64

10. Esito secondario

    Change from Baseline in Body Mass Index (BMI)

    Change from Baseline in BMI

    Orizzonte temporale Baseline, Week 64

11. Esito secondario

    Change in Medication Use

    Change in Medication Use

    Orizzonte temporale Baseline, Week 64

12. Esito secondario

    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

    Orizzonte temporale Baseline, Week 64

13. Esito secondario

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

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

    Orizzonte temporale Baseline, Week 64

14. Esito secondario

    Percent Change from Baseline in Fasting Insulin

    Percent Change from Baseline in Fasting Insulin

    Orizzonte temporale Baseline, Week 64

15. Esito secondario

    Percent Change from Baseline in Total Cholesterol

    Percent Change from Baseline in Total Cholesterol

    Orizzonte temporale Baseline, Week 64

16. Esito secondario

    Change from Baseline in Waist Circumference

    Change from Baseline in Waist Circumference

    Orizzonte temporale Baseline, Week 64

17. Esito secondario

    Percent Change from Baseline in Hemoglobin A1c (HbA1c)

    Percent Change from Baseline in HbA1c

    Orizzonte temporale Baseline, Week 64

18. Esito secondario

    Change from Baseline in WOMAC Stiffness Subscale Score

    Change from Baseline in WOMAC Stiffness Subscale Score

    Orizzonte temporale Baseline, Week 64

19. Esito secondario

    Change from Baseline in WOMAC Total Score

    Change from Baseline in WOMAC Total Score

    Orizzonte temporale Baseline, Week 64

20. Esito secondario

    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

    Orizzonte temporale Baseline, Week 64

21. Esito secondario

    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

    Orizzonte temporale Baseline, Week 64

22. Esito secondario

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

    Change from Baseline in API-NRS Score

    Orizzonte temporale Baseline, Week 64

23. Esito secondario

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

    Change from Baseline in WPI-NRS Score

    Orizzonte temporale Baseline, Week 64

24. Esito secondario

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

    PK: Cmax, ss

    Orizzonte temporale Baseline through Week 64

25. Esito secondario

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

    PK: AUC(0-T)ss

    Orizzonte temporale Baseline through Week 64

26. Esito secondario

    Number of Participants with Allowed Concomitant Pain Medication

    Number of Participants with Allowed Concomitant Pain Medication

    Orizzonte temporale Baseline, Week 64

Date

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

126 centri stanno reclutando

Nella scheda del registro sono indicati altri 102 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

1. 6 agosto 2026

   Centro rimosso

   9 sites removed (152 total)

   161 → 152