2024-520443-16-00招募中3 期
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4)
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
- 115
- 试验地点
- 25
- 主要终点
- Relative change in body weight
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 obstructive sleep apnoea (OSA) on positive airway pressure (PAP) therapy
- To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in apnoea-hypopnoea index (AHI) in participants with overweight or obesity, and OSA on PAP therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 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 informed consent.
- •Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening.
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.
- •Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy.
- •Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence.
- •Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within CCI before screening.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10145 (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10141 (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10142 (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10144 (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10143 (Drug)
NNC0487-0111 B 10145, NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10143, NNC0487-0111 B 10146
Test
干预措施: NNC0487-0111 B 10146 (Drug)
结局指标
主要结局
Relative change in body weight
Relative change in body weight
Change in apnoea-hypopnoea index (AHI)
Change in apnoea-hypopnoea index (AHI)
次要结局
- Relative change in AHI
- Achievement of 50% reduction in AHI (Yes/No)
- Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
- Change in sleep apnoea specific hypoxic burden (SASHB)
- Change in ESS score
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
- Change in body weight
- Change in body mass index (BMI)
- Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) ≥ 5 and < 15/hour = mild (Yes/No) ≥ 15 and < 30/hour = moderate (Yes/No) ≥ 30/hour = severe (Yes/No)
- Withdrawal of positive airway pressure (PAP) therapy (Yes/No)
- Change in waist circumference
- Change in neck circumference
- Change in systolic blood pressure (SBP)
- Change in diastolic blood pressure (DBP)
- Change in high-sensitivity C-reactive protein (hsCRP)
- 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 fasting plasma glucose
- Change in glycated haemoglobin (HbA1c)
- Number of: Treatment emergent adverse events (TEAEs) Treatment emergent serious adverse events (TESAEs) TEAEs leading to permanent treatment discontinuation
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (25)
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