2024-520440-42-00招募中3 期
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)
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
- 270
- 试验地点
- 22
- 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, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with obesity
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 18CCI years CCI at the time of signing the informed consent.
- •Body Mass Index (BMI) CCI kg/m2 .
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.
研究组 & 干预措施
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10145 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10146 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: zenagamtide B 10176 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10144 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10141 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10142 (Drug)
zenagamtide B 10176, NNC0487-0111 B 10144, NNC0487-0111 B 10141, NNC0487-0111 B 10145, NNC0487-0111 B 10142, NNC0487-0111 B 10146, NNC0487-0111 B 10143
Test
干预措施: NNC0487-0111 B 10143 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change in body weight
Relative change in body weight
次要结局
- CCI
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea
- Change in body weight
- Change in body mass index (BMI)
- Change in IWQOL-Lite-CT Physical composite score Psychosocial composite score Total score
- Change in glycated haemoglobin (HbA1c)
- Change in fasting plasma glucose (FPG)
- Change in fasting insulin
- Change in diastolic blood pressure (DBP)
- 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)
- Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation
- Extension phase secondary endpoints are as follows: Relative change in body weight
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT): Physical composite score Physical functioning score Psychosocial composite score Total score
- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglyceride
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (22)
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