NCT02941042已完成1 期
This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
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
- 49
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening
排除标准
- •Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- •Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above or equal to 5%
- •Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are 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) (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 investigational medical product
研究组 & 干预措施
NNC9204-1177
Experimental
干预措施: NNC9204-1177 (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 dosing (day 1) until completion of the follow-up visit (day 39)
次要结局
- Change in body weight(Day 1, day 39)
- Area under the NNC9204-1177 serum concentration-time curve(From 0 to 168 hours after a single s.c. dose)
- Maximum serum concentration of NNC9204-1177(From time of dosing (day 1) until completion of the follow-up visit (day 39))
- Time to maximum serum concentration of NNC9204-1177(From time of dosing (day 1) until completion of the follow-up visit (day 39))
- Change in QT interval corrected using the Fridericia formula (QTcF)(Day 1, day 39)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic AgentDiabetesDiabetes Mellitus, Type 2NCT01511198Novo Nordisk A/S223
已完成
1 期
A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 DiabetesHealthy VolunteersDiabetes Mellitus, Type 2NCT04262661Novo Nordisk A/S36
终止
1 期
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female VolunteersMetabolism and Nutrition DisorderObesityNCT00665665Novo Nordisk A/S101
已完成
1 期
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or ObesityMetabolism and Nutrition DisorderObesityNCT03015207Novo Nordisk A/S56
已完成
1 期
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 DiabetesHealthy VolunteersDiabetes Mellitus, Type 1NCT03965013Novo Nordisk A/S78