The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and knee osteoarthritis. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
NNC0487-0111 dose level 1 and dose level 2 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Arizona Research Center, Inc.
Phoenix, Arizona, United States
RECRUITINGDiablo Clinical Research, Inc.
Walnut Creek, California, United States
RECRUITINGChase Medical Research LLC
Hamden, Connecticut, United States
RECRUITINGChase Medical Research LLC
Waterbury, Connecticut, United States
Relative change in body weight
Measured as percentage (%) of body weight.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (week 0) to (week 80)
Change in body weight
Measured as kilogram (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
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.
Time frame: 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.
Time frame: From baseline (week 0) to (week 80)
Change in waist circumference
Measured as centimetre (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)
Change in total cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in high-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in very low-density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in non-HDL cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in triglycerides
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline.
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 liter (mmol/L).
Time frame: From baseline (week 0) to (week 80)
Number of participants allowed using rescue analgesics during washout period (Yes/no)
Measured as number 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)
Use of pain medication (Yes/No)
Measured as number 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 number of participants.
Time frame: 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.
Time frame: From baseline (week 0) to (week 80)
Number of treatment Emergent Adverse Events (TEAEs)
Measured as number of events.
Time frame: From baseline (week 0) to week 84
Number of treatment Emergent Serious Adverse Events (TESAEs)
Measured as number of events.
Time frame: From baseline (week 0) to week 84
Number of TEAEs leading to permanent treatment discontinuation
Measured as number of events.
Time frame: From baseline (week 0) to week 84
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