2024-520445-23-00招募中3 期
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 6)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 40
- 主要终点
- Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
研究概览
简要总结
- To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and knee osteoarthritis (OA)
- To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in knee OA related pain in participants with overweight or obesity, and knee OA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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.
- •Body mass index (BMI) CCI kg/m2 at screening.
- •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 kneea. 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 g/day is allowed as rescue medication up until 24 hours before those visits).
排除标准
- •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 within CCI 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 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10146 (Drug)
NNC0487-0111 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10143 (Drug)
NNC0487-0111 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10141 (Drug)
NNC0487-0111 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10144 (Drug)
NNC0487-0111 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10145 (Drug)
NNC0487-0111 B 10146, NNC0487-0111 B 10143, NNC0487-0111 B 10141, NNC0487-0111 B 10144, NNC0487-0111 B 10145, NNC0487-0111 B 10142
Test
干预措施: NNC0487-0111 B 10142 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
Relative change in body weight
Relative change in body weight
次要结局
- Use of pain medication (Yes/No)
- Amount of allowed rescue analgesics used during washout period
- Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation
- CCI
- Change in WOMAC physical function scorea
- Change in diastolic blood pressure (DBP)
- Amount of pain medication used
- Change in pain medication (decrease/no change/increase)
- Change in knee pain intensity (NRS)
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
- Change in body weight
- Change in body mass index (BMI)
- Change in WOMAC stiffness score
- Change in WOMAC total score
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides
- Change in high-sensitivity C-reactive protein (hsCRP)
- Change in glycated haemoglobin (HbA1c)
- Change in fasting plasma glucose (FPG)
- Use of allowed rescue analgesics during washout period (Yes/no)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (40)
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