Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 82
- 主要终点
- Relative change in body weight
研究概览
简要总结
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
NNC0487-0111 dose level 2
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: NNC0487-0111 (Drug)
NNC0487-0111 dose level 1
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: NNC0487-0111 (Drug)
Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (matched to NNC0487-0111 ) (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: 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
时间窗: 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.
次要结局
- Change in WOMAC physical function score(From baseline (week 0) to (week 80))
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score(From baseline (week 0) to (week 80))
- Change in body weight(From baseline (week 0) to (week 80))
- Change in body mass index (BMI)(From baseline (week 0) to (week 80))
- Change in WOMAC stiffness score(From baseline (week 0) to (week 80))
- Change in WOMAC total score(From baseline (week 0) to (week 80))
- Change in waist circumference(From baseline (week 0) to (week 80))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to (week 80))
- Change in diastolic blood pressure (DBP)(From baseline (week 0) to (week 80))
- Change in total cholesterol(From baseline (week 0) to (week 80))
- Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to (week 80))
- Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to (week 80))
- Change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to (week 80))
- Change in non-HDL cholesterol(From baseline (week 0) to (week 80))
- Change in triglycerides(From baseline (week 0) to (week 80))
- Change in high-sensitivity C-reactive protein (hsCRP)(From baseline (week 0) to (week 80))
- Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to (week 80))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to (week 80))
- Number of participants allowed using rescue analgesics during washout period (Yes/no)(From baseline (week 0) to (week 80))
- Amount of allowed rescue analgesics used during washout period(From baseline (week 0) to (week 80))
- Use of pain medication (Yes/No)(From baseline (week 0) to (week 80))
- Amount of pain medication used(From baseline (week 0) to (week 80))
- Number of participants with change in pain medication (decrease/no change/increase)(From baseline (week 0) to (week 80))
- Change in knee pain intensity (NRS)(From baseline (week 0) to (week 80))
- Number of treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to week 84)
- Number of treatment Emergent Serious Adverse Events (TESAEs)(From baseline (week 0) to week 84)
- Number of TEAEs leading to permanent treatment discontinuation(From baseline (week 0) to week 84)