Obesity, Overweight, Osteoarthritis, Knee
Conditions
Brief summary
This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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.
Interventions
DRUGNNC0487-0111
NNC0487-0111 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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth) * Age 18 years or above at the time of signing the informed consent * Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence \[KL\] grades 2 to 4 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg * Symptomatic knee OA with first appearance of pain in the target knee \> 90 days prior to screening and pain in the target knee for \> 15 days over the prior 30 days * Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 grams (g)/day is allowed as rescue medication up until 24 hours before those visits) Key
Exclusion criteria
* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records * Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening * Any joint prosthesis or joint replacement in target knee * Arthroscopy or injections into target knee within the last 90 days prior to screening * Any other joint disease in target knee including gout and pseudogout
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to week 80 | Measured as percentage change in body weight. |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score | From baseline (week 0) to week 80 | WOMAC is a participant reported outcome (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 pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC physical function score | From baseline (week 0) to week 80 | 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. |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | From baseline (week 0) to week 80 | 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. |
| Change in body weight | From baseline (week 0) to week 80 | Measured as kilograms (kg). |
| Change in body mass index (BMI) | From baseline (week 0) to week 80 | Measured as kilograms per meter squared (kg/m\^2). |
| Change in WOMAC stiffness score | From baseline (week 0) to week 80 | 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. |
| Change in WOMAC total score | From baseline (week 0) to week 80 | 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. |
| Change in waist circumference | From baseline (week 0) to week 80 | Measured as centimetres (cm). |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to week 80 | Measured as millimetre of mercury (mmHg). |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to week 80 | Measured as mmHg. |
| Ratio to baseline: change in total cholesterol | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in non-HDL cholesterol | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in triglycerides | From baseline (week 0) to week 80 | Measured as ratio. |
| Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to week 80 | Measured as ratio. |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to week 80 | Measured as percentage of HbA1c. |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to week 80 | Measured as millimole per litre (mmol/L). |
| Number of participants with use of allowed rescue analgesics during washout period (yes/no) | From baseline (week 0) to week 80 | Measured as count of participants. |
| Amount of allowed rescue analgesics used during washout period | From baseline (week 0) to week 80 | Measured as dose of analgesics. |
| Number of participants with use of pain medication (yes/no) | From baseline (week 0) to week 80 | Measured as count of participants. |
| Amount of pain medication used | From baseline (week 0) to week 80 | Measured as dose of pain medication. |
| Number of participants with change in pain medication (decrease/no change/increase) | From baseline (week 0) to week 80 | Measured as count of participants. |
| Change in knee pain intensity score (NRS) | From baseline (week 0) to week 80 | 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. |
| Number of treatment emergent adverse events (TEAEs) | From baseline (week 0) to week 84 | Measured as events. |
| Number of treatment emergent serious adverse events (TESAEs) | From baseline (week 0) to week 84 | Measured as events. |
| Number of TEAEs leading to permanent treatment discontinuation | From baseline (week 0) to week 84 | Measured as events. |
Countries
Australia, Bulgaria, Canada, Denmark, Greece, Italy, Poland, Puerto Rico, Spain, Turkey (Türkiye), United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed