Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis

Study Overview
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Brief Summary
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This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking dummy medicine. Participants will either get semaglutide or dummy medicine. Which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed. At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Official Title
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Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

Conditions
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Obesity

Intervention / Treatment
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* Drug: semaglutide 2.4 mg
* Drug: semaglutide 2.4 mg (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age above or equal to 18 years at the time of signing informed consent Body Mass Index (BMI) equal to or greater than 30.0 kg/m^2 Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg. Pain due to knee OA Exclusion Criteria: Joint replacement in target knee Arthroscopy or injections into target knee within last 3 months prior to enrolment Any other joint disease in the target knee
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: semaglutide 2.4 mg<br>Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity | Drug: semaglutide 2.4 mg<br>* semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity<br>|
| Placebo Comparator: semaglutide 2.4 mg (placebo)<br>Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity | Drug: semaglutide 2.4 mg (placebo)<br>* semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Percentage | From baseline (week 0) to end of treatment (week 68) | 
| Change in WOMAC pain score | Score points | From baseline (week 0) to end of treatment (week 68) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving body weight reduction greater than or equal to 5% (yes/no) | Count of subjects | From baseline (week 0) to end of treatment (week 68) | 
| Achieving body weight reduction greater than or equal to 10% (yes/no) | Count of subjects | From baseline (week 0) to end of treatment (week 68) | 
| Change in WOMAC physical function score | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in SF-36 physical functioning score | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in waist circumference | cm | From baseline (week 0) to end of treatment (week 68) | 
| Change in WOMAC stiffness score | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in WOMAC total score | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in SF-36 bodily pain score | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in SF-36 physical component summary | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Change in SF-36 mental component summary | Score points | From baseline (week 0) to end of treatment (week 68) | 
| Use of allowed rescue analgesics during wash out | Count of subjects | From baseline (week 0) to end of treatment (week 68) | 
| Amount of allowed rescue analgesics used during wash out | Dose | From baseline (week 0) to end of treatment (week 68) | 
| Change in pain medication | Dose | From baseline (week 0) to end of treatment (week 68) | 
| Change in pain intensity (NRS) | Score points | From baseline (week 0) to end of treatment (week 68) |