Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 121
- 主要终点
- Percentage Change in Body Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
semaglutide 2.4 mg
Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity
干预措施: semaglutide 2.4 mg (Drug)
semaglutide 2.4 mg (placebo)
Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
干预措施: semaglutide 2.4 mg (placebo) (Drug)
结局指标
主要结局
Percentage Change in Body Weight
时间窗: Baseline (week 0), end of treatment (week 68)
Percentage change in body weight from baseline (week 0) to end of treatment (week 68) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
时间窗: Baseline (week 0), end of treatment (week 68)
WOMAC is a disease-specific patient-reported outcome measure designed to assess changes in symptoms and lower extremity functioning associated with treatment in patients with osteoarthritis of the hip and/or knee. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with osteoarthritis (OA). It consists of 3 subscales: pain, stiffness and physical function. The WOMAC raw pain score is derived as the sum of the 5 item scores in the pain domain. It will be normalised and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the pain domain (i.e. 50) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
次要结局
- Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Change in WOMAC Physical Function Score(Baseline (week 0), end of treatment (week 68))
- Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Change in Short Form 36 (SF-36) Physical Functioning Score(Baseline (week 0), end of treatment (week 68))
- Change in Waist Circumference(Baseline (week 0), end of treatment (week 68))
- Change in WOMAC Total Score(Baseline (week 0), end of treatment (week 68))
- Change in WOMAC Stiffness Score(Baseline (week 0), end of treatment (week 68))
- Percentage of Participants Using Allowed Rescue Analgesics During Wash Out (Yes/No)(At end of treatment (week 68))
- Change in SF-36 Bodily Pain Score(Baseline (week 0), end of treatment (week 68))
- Amount of Allowed Rescue Analgesics Used During Wash Out(At end of treatment (week 68))
- Percentage of Participants With Use of Pain Medication(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Body Weight Reduction ≥ 20% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving WOMAC Pain Reduction ≥ 50% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Pain Score (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Change in SF-36 Physical Component Summary(Baseline (week 0), end of treatment (week 68))
- Change in Pain Intensity (Numerical Rating Scale [NRS])(Baseline (week 0), end of treatment (week 68))
- Percentage of Participants Achieving Body Weight Reduction ≥ 15% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Change in SF-36 Mental Component Summary(Baseline (week 0), end of treatment (week 68))
- Percentage of Participants Achieving WOMAC Pain Reduction ≥ 30% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Physical Function Score (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 30% (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in SF-36 Physical Functioning Score (Yes/No)(From baseline (week 0) to end of treatment (week 68))
- Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 50% (Yes/No)(From baseline (week 0) to end of treatment (week 68))