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

Resumen

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.

Elegibilidad

Diseño del estudio

Variables de resultado

1. Variable de resultado principal

   Percent Change from Baseline in Body Weight

   Percent Change from Baseline in Body Weight

   Plazo Baseline, Week 64

2. Variable de resultado 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

   Plazo Baseline, Week 64

3. Variable de resultado secundaria

   Change from Baseline in Systolic Blood Pressure (SBP)

   Change from Baseline in SBP

   Plazo Baseline, Week 64

4. Variable de resultado secundaria

   Percent Change from Baseline in Triglycerides

   Percent Change in Baseline in Triglycerides

   Plazo Baseline, Week 64

5. Variable de resultado secundaria

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

   Change from Baseline in SF-36 v2 Score

   Plazo Baseline, Week 64

6. Variable de resultado secundaria

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

   Percent Change from Baseline in hsCRP

   Plazo Baseline, Week 64

7. Variable de resultado secundaria

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Change from Baseline in the WOMAC Physical Function Subscale Score

   Plazo Baseline, Week 40, Week 64

8. Variable de resultado secundaria

   Change from Baseline WOMAC Pain Subscale Score

   Change from Baseline WOMAC Pain Subscale Score

   Plazo Baseline, Week 40

9. Variable de resultado secundaria

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

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

   Plazo Baseline, Week 64

10. Variable de resultado secundaria

    Change from Baseline in Body Mass Index (BMI)

    Change from Baseline in BMI

    Plazo Baseline, Week 64

11. Variable de resultado secundaria

    Change in Medication Use

    Change in Medication Use

    Plazo Baseline, Week 64

12. Variable de resultado secundaria

    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

    Plazo Baseline, Week 64

13. Variable de resultado secundaria

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

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

    Plazo Baseline, Week 64

14. Variable de resultado secundaria

    Percent Change from Baseline in Fasting Insulin

    Percent Change from Baseline in Fasting Insulin

    Plazo Baseline, Week 64

15. Variable de resultado secundaria

    Percent Change from Baseline in Total Cholesterol

    Percent Change from Baseline in Total Cholesterol

    Plazo Baseline, Week 64

16. Variable de resultado secundaria

    Change from Baseline in Waist Circumference

    Change from Baseline in Waist Circumference

    Plazo Baseline, Week 64

17. Variable de resultado secundaria

    Percent Change from Baseline in Hemoglobin A1c (HbA1c)

    Percent Change from Baseline in HbA1c

    Plazo Baseline, Week 64

18. Variable de resultado secundaria

    Change from Baseline in WOMAC Stiffness Subscale Score

    Change from Baseline in WOMAC Stiffness Subscale Score

    Plazo Baseline, Week 64

19. Variable de resultado secundaria

    Change from Baseline in WOMAC Total Score

    Change from Baseline in WOMAC Total Score

    Plazo Baseline, Week 64

20. Variable de resultado secundaria

    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

    Plazo Baseline, Week 64

21. Variable de resultado secundaria

    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

    Plazo Baseline, Week 64

22. Variable de resultado secundaria

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

    Change from Baseline in API-NRS Score

    Plazo Baseline, Week 64

23. Variable de resultado secundaria

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

    Change from Baseline in WPI-NRS Score

    Plazo Baseline, Week 64

24. Variable de resultado secundaria

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

    PK: Cmax, ss

    Plazo Baseline through Week 64

25. Variable de resultado secundaria

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

    PK: AUC(0-T)ss

    Plazo Baseline through Week 64

26. Variable de resultado secundaria

    Number of Participants with Allowed Concomitant Pain Medication

    Number of Participants with Allowed Concomitant Pain Medication

    Plazo Baseline, Week 64

Fechas

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

126 centros están en reclutamiento

En el registro figuran 102 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

1. 6 de agosto de 2026

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