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

Résumé

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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Percent Change from Baseline in Body Weight

   Percent Change from Baseline in Body Weight

   Délai Baseline, Week 64

2. Critère de jugement principal

   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

   Délai Baseline, Week 64

3. Critère de jugement secondaire

   Change from Baseline in Systolic Blood Pressure (SBP)

   Change from Baseline in SBP

   Délai Baseline, Week 64

4. Critère de jugement secondaire

   Percent Change from Baseline in Triglycerides

   Percent Change in Baseline in Triglycerides

   Délai Baseline, Week 64

5. Critère de jugement secondaire

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

   Change from Baseline in SF-36 v2 Score

   Délai Baseline, Week 64

6. Critère de jugement secondaire

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

   Percent Change from Baseline in hsCRP

   Délai Baseline, Week 64

7. Critère de jugement secondaire

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Délai Baseline, Week 40, Week 64

8. Critère de jugement secondaire

   Change from Baseline WOMAC Pain Subscale Score

   Change from Baseline WOMAC Pain Subscale Score

   Délai Baseline, Week 40

9. Critère de jugement secondaire

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

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

   Délai Baseline, Week 64

10. Critère de jugement secondaire

    Change from Baseline in Body Mass Index (BMI)

    Change from Baseline in BMI

    Délai Baseline, Week 64

11. Critère de jugement secondaire

    Change in Medication Use

    Change in Medication Use

    Délai Baseline, Week 64

12. Critère de jugement secondaire

    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

    Délai Baseline, Week 64

13. Critère de jugement secondaire

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

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

    Délai Baseline, Week 64

14. Critère de jugement secondaire

    Percent Change from Baseline in Fasting Insulin

    Percent Change from Baseline in Fasting Insulin

    Délai Baseline, Week 64

15. Critère de jugement secondaire

    Percent Change from Baseline in Total Cholesterol

    Percent Change from Baseline in Total Cholesterol

    Délai Baseline, Week 64

16. Critère de jugement secondaire

    Change from Baseline in Waist Circumference

    Change from Baseline in Waist Circumference

    Délai Baseline, Week 64

17. Critère de jugement secondaire

    Percent Change from Baseline in Hemoglobin A1c (HbA1c)

    Percent Change from Baseline in HbA1c

    Délai Baseline, Week 64

18. Critère de jugement secondaire

    Change from Baseline in WOMAC Stiffness Subscale Score

    Change from Baseline in WOMAC Stiffness Subscale Score

    Délai Baseline, Week 64

19. Critère de jugement secondaire

    Change from Baseline in WOMAC Total Score

    Change from Baseline in WOMAC Total Score

    Délai Baseline, Week 64

20. Critère de jugement secondaire

    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

    Délai Baseline, Week 64

21. Critère de jugement secondaire

    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

    Délai Baseline, Week 64

22. Critère de jugement secondaire

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

    Change from Baseline in API-NRS Score

    Délai Baseline, Week 64

23. Critère de jugement secondaire

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

    Change from Baseline in WPI-NRS Score

    Délai Baseline, Week 64

24. Critère de jugement secondaire

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

    PK: Cmax, ss

    Délai Baseline through Week 64

25. Critère de jugement secondaire

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

    PK: AUC(0-T)ss

    Délai Baseline through Week 64

26. Critère de jugement secondaire

    Number of Participants with Allowed Concomitant Pain Medication

    Number of Participants with Allowed Concomitant Pain Medication

    Délai Baseline, Week 64

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

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Documents de l'étude

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