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临床试验/2024-520442-36-00
2024-520442-36-00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 not treated with positive airway pressure (AMAZE 3)

Novo Nordisk A/S27 个研究点 分布在 4 个国家目标入组 125 人开始时间: 2026年4月20日最近更新:
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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
125
试验地点
27
主要终点
Relative change in body weight
研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. 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)
  2. 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

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

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10145 (Drug)

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10143 (Drug)

Placebo

Placebo

干预措施: Placebo (Drug)

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10142 (Drug)

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10141 (Drug)

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10146 (Drug)

NNC0487-0111 B 10145, NNC0487-0111 B 10143, NNC0487-0111 B 10142, NNC0487-0111 B 10141, NNC0487-0111 B 10146, NNC0487-0111 B 10144

Test

干预措施: NNC0487-0111 B 10144 (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

  • Change in systolic blood pressure (SBP)
  • Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
  • Change in ESS score
  • Change in neck circumference
  • Achievement of 50% reduction in AHI (Yes/No)
  • Relative change in AHI
  • Change in high-sensitivity C-reactive protein (hsCRP)
  • Change in diastolic blood pressure (DBP)
  • Change in sleep apnoea specific hypoxic burden (SASHB)
  • Change in waist circumference
  • 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)
  • CCI
  • 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

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

EU Submission Hub

Scientific

Novo Nordisk A/S

研究点 (27)

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