Radar degli Studi Clinici

Relative change in body weight

Measured as percentage (%) of body weight.

From baseline (week 0) to (week 80)

Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.

From baseline (week 0) to (week 80)

Change in WOMAC physical function score

Measured as score on a scale. Physical function score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse physical function.

From baseline (week 0) to (week 80)

Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.

From baseline (week 0) to (week 80)

Change in body weight

Measured as kilogram (kg).

From baseline (week 0) to (week 80)

Change in body mass index (BMI)

Measured as kilograms per meter squared (kg/m\^2).

From baseline (week 0) to (week 80)

Change in WOMAC stiffness score

Measured as score on a scale. Stiffness score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse stiffness.

From baseline (week 0) to (week 80)

Change in WOMAC total score

Measured as score on a scale. Total score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Total score ranges from 0-100 and higher scores indicate worse overall osteoarthritis- related disability.

From baseline (week 0) to (week 80)

Change in waist circumference

Measured as centimetre (cm).

From baseline (week 0) to (week 80)

Change in systolic blood pressure (SBP)

Measured as millimetre of mercury (mmHg).

From baseline (week 0) to (week 80)

Change in diastolic blood pressure (DBP)

Measured as mmHg.

From baseline (week 0) to (week 80)

Change in total cholesterol

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in high-density lipoprotein (HDL) cholesterol

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in low-density lipoprotein (LDL) cholesterol

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in very low-density lipoprotein (VLDL) cholesterol

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in non-HDL cholesterol

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in triglycerides

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in high-sensitivity C-reactive protein (hsCRP)

Measured as ratio to baseline.

From baseline (week 0) to (week 80)

Change in glycated haemoglobin (HbA1c)

Measured as percentage (%) of HbA1c.

From baseline (week 0) to (week 80)

Change in fasting plasma glucose (FPG)

Measured as millimole per liter (mmol/L).

From baseline (week 0) to (week 80)

Number of participants allowed using rescue analgesics during washout period (Yes/no)

Measured as number of participants

From baseline (week 0) to (week 80)

Amount of allowed rescue analgesics used during washout period

Measured as dose of analgesics.

From baseline (week 0) to (week 80)

Use of pain medication (Yes/No)

Measured as number of participants.

From baseline (week 0) to (week 80)

Amount of pain medication used

Measured as dose of pain medication.

From baseline (week 0) to (week 80)

Number of participants with change in pain medication (decrease/no change/increase)

Measured as number of participants.

From baseline (week 0) to (week 80)

Change in knee pain intensity (NRS)

Measured as score on a scale. Knee pain numerical rating scale (NRS) measures knee pain at its worst in the last 24 hours. The measure consists of 1 item. The response scale is an 11-point numeric rating scale from 0 (No knee pain) to 10 (Worst possible knee pain). Higher scores indicate worse pain.

From baseline (week 0) to (week 80)

Number of treatment Emergent Adverse Events (TEAEs)

Measured as number of events.

From baseline (week 0) to week 84

Number of treatment Emergent Serious Adverse Events (TESAEs)

Measured as number of events.

From baseline (week 0) to week 84

Number of TEAEs leading to permanent treatment discontinuation

Measured as number of events.

From baseline (week 0) to week 84