Obesity, Knee Osteoarthritis (OA)
Conditions
Brief summary
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.
Interventions
DRUGNNC0487-0111
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.
DRUGPlacebo (matched to NNC0487-0111 )
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)
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 (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 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 more than (\>) 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 gram (g)/day is allowed as rescue medication up until 24 hours before those visits).
Exclusion criteria
* Glycated haemoglobin more than or equal to (≥) 6.5% \[(48 millimoles per mole (mmol/mol)\] 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 (%) of body weight. |
| Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score | From baseline (week 0) to (week 80) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC physical function score | From baseline (week 0) to (week 80) | 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. |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | From baseline (week 0) to (week 80) | 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. |
| Change in body weight | From baseline (week 0) to (week 80) | Measured as kilogram (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) | 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. |
| Change in WOMAC total score | From baseline (week 0) to (week 80) | 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. |
| Change in waist circumference | From baseline (week 0) to (week 80) | Measured as centimetre (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. |
| Change in total cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in non-HDL cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in triglycerides | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| 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 liter (mmol/L). |
| Number of participants allowed using rescue analgesics during washout period (Yes/no) | From baseline (week 0) to (week 80) | Measured as number of participants |
| Amount of allowed rescue analgesics used during washout period | From baseline (week 0) to (week 80) | Measured as dose of analgesics. |
| Use of pain medication (Yes/No) | From baseline (week 0) to (week 80) | Measured as number 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 number of participants. |
| Change in knee pain intensity (NRS) | From baseline (week 0) to (week 80) | 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. |
| Number of treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to week 84 | Measured as number of events. |
| Number of treatment Emergent Serious Adverse Events (TESAEs) | From baseline (week 0) to week 84 | Measured as number of events. |
| Number of TEAEs leading to permanent treatment discontinuation | From baseline (week 0) to week 84 | Measured as number of events. |
Countries
Australia, Bulgaria, Canada, Denmark, Greece, Italy, Poland, Spain, Turkey (Türkiye), United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed