NCT02958085已完成1 期
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator
排除标准
- •History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention
- •History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure
- •History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
- •Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) of childbearing potential (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product
研究组 & 干预措施
NNC0174-0833
Experimental
干预措施: NNC0174-0833 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)
次要结局
- The area under the NNC0174-0833 plasma concentration-time curve(From time 0 to 168 hours at steady state)
- The maximum concentration of NNC0174-0833 in plasma at steady state(Day 1; Day 57)
研究者
研究点 (1)
Loading locations...
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