NCT07571109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
- 300
- 试验地点
- 105
- 主要终点
- Relative change in body weight
研究概览
简要总结
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. 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) and 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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 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 before screening
研究组 & 干预措施
NNC0487-0111
Experimental
Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: NNC0487-0111 (Drug)
Placebo
Placebo Comparator
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 (%) change in body weight.
Change in apnoea-hypopnoea index (AHI)
时间窗: From baseline (week 0) to (week 80)
Measured as events/hour.
次要结局
- Relative change in AHI(From baseline (week 0) to (week 80))
- Achievement of 50% reduction in AHI (Yes/No)(From baseline (week 0) to (week 80))
- Achievement of: AHI less than (<) 5(From baseline (week 0) to (week 80))
- Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)(From baseline (week 0) to (week 80))
- Change in sleep apnoea specific hypoxic burden (SASHB)(From baseline (week 0) to (week 80))
- Change in ESS score(From baseline (week 0) to (week 80))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score(From baseline (week 0) to (week 80))
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b 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))
- Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)(From baseline (week 0) to (week 80))
- Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No)(From baseline (week 0) to (week 80))
- Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No)(From baseline (week 0) to (week 80))
- Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No)(From baseline (week 0) to (week 80))
- Withdrawal of positive airway pressure (PAP) therapy (Yes/No)(From baseline (week 0) to (week 80))
- Change in waist circumference(From baseline (week 0) to (week 80))
- Change in neck 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 high-sensitivity C-reactive protein (hsCRP)(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 fasting plasma glucose(From baseline (week 0) to (week 80))
- Change in glycated haemoglobin (HbA1c)(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)
研究者
研究点 (105)
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