AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Change in WOMAC physical function score

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for physical function ranges 0-100, where higher score indicates worse physical function. Measured as score on a scale.

Time frame: From baseline (week 0) to week 80

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

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, i.e. 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. Measured as score on a scale.

Time frame: From baseline (week 0) to week 80

Change in body weight

Measured as kilograms (kg).

Time frame: From baseline (week 0) to week 80

Change in body mass index (BMI)

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

Time frame: From baseline (week 0) to week 80

Change in WOMAC stiffness score

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for stiffness ranges 0-100, where higher score indicates worse stiffness. Measured as score on a scale.

Time frame: From baseline (week 0) to week 80

Change in WOMAC total score

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Total score ranges 0-100, where higher score indicates worse pain, stiffness, physical function and overall osteoarthritis related disability. Measured as score on a scale.

Time frame: From baseline (week 0) to week 80

Change in waist circumference

Measured as centimetres (cm).

Time frame: From baseline (week 0) to week 80

Change in systolic blood pressure (SBP)

Measured as millimetre of mercury (mmHg).

Time frame: From baseline (week 0) to week 80

Change in diastolic blood pressure (DBP)

Measured as mmHg.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in total cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in non-HDL cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in triglycerides

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

Measured as ratio.

Time frame: From baseline (week 0) to week 80

Change in glycated haemoglobin (HbA1c)

Measured as percentage of HbA1c.

Time frame: From baseline (week 0) to week 80

Change in fasting plasma glucose (FPG)

Measured as millimole per litre (mmol/L).

Time frame: From baseline (week 0) to week 80

Number of participants with use of allowed rescue analgesics during washout period (yes/no)

Measured as count of participants.

Time frame: From baseline (week 0) to week 80

Amount of allowed rescue analgesics used during washout period

Measured as dose of analgesics.

Time frame: From baseline (week 0) to week 80

Number of participants with use of pain medication (yes/no)

Measured as count of participants.

Time frame: From baseline (week 0) to week 80

Amount of pain medication used

Measured as dose of pain medication.

Time frame: From baseline (week 0) to week 80

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

Measured as count of participants.

Time frame: From baseline (week 0) to week 80

Change in knee pain intensity score (NRS)

NRS item is PRO measures knee pain at its worst. 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. Measured as score on a scale.

Time frame: From baseline (week 0) to week 80

Number of treatment emergent adverse events (TEAEs)

Measured as events.

Time frame: From baseline (week 0) to week 84

Number of treatment emergent serious adverse events (TESAEs)

Measured as events.

Time frame: From baseline (week 0) to week 84

Number of TEAEs leading to permanent treatment discontinuation

Measured as events.

Time frame: From baseline (week 0) to week 84