Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
2019年10月17日 更新者：Novo Nordisk A/S
A Randomised, Double-blinded, Multiple-dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC9204-1706 in Subjects Being Overweight or With Obesity
The study is testing a new medicine for weight control in people with overweight or obesity.
The aim of the study is to find out how safe the study medicine is and how it works in the body.
Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy medicine) - which treatment participants get is decided by chance.
NNC9204-1706 is a new medicine which cannot be prescribed by doctors.
Participants will get an injection under the skin of participants' stomach each morning for 10 weeks.
A medical tool called NovoPen®4 will be used for the injection.
Participants must change the part of the pen including the medicine (the cartridge) each day.
The study will last for about 16 weeks.
Participants will have at least 17 clinic visits and 10 phone calls with the study doctor.
At certain times during the study, participants will have blood drawn and 3 different kinds of heart tests (electrocardiograms). Study doctor will ask participants to answer mental health surveys.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kansas
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Overland Park、Kansas、美国、66212
- Novo Nordisk Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female, aged 18-55 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 adipose tissue, as judged by the investigator.
Exclusion Criteria:
- Female subject who is of childbearing potential (pre-menopausal and not surgically sterilised) and is sexually active with male partner(s) who are not surgically sterilised (vasectomy) or who is not using highly effective contraceptive methods (Pearl Index less than 1%) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
- Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their nonpregnant female partner(s) (Pearl Index less than 1%), and/or intend to donate sperm in the period from screening until 90 days following administration of the investigational medical product.
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NNC9204-1706
Participants will receive NNC9204-1706 for 10 weeks.
There will be a 2-week follow-up period after the treatment period.
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Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks.
They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
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安慰剂比较：Placebo (NNC9204-1706)
Participants will receive placebo (NNC9204-1706) for 10 weeks.
There will be a 2-week follow-up period after the treatment period.
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Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of treatment emergent adverse events (TEAEs)
大体时间：Days 1-84
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Count of adverse events.
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Days 1-84
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in time-profile (msec) in individual corrected QT interval (ΔQTcI)
大体时间：Day 1, Day 84
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Measured in msec.
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Day 1, Day 84
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AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state
大体时间：Days 1-84
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Measured in h*nmol/L.
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Days 1-84
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Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state
大体时间：Days 1-84
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Measured in nmol/L.
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Days 1-84
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月12日
初级完成 (实际的)
2019年9月5日
研究完成 (实际的)
2019年10月9日
研究注册日期
首次提交
2018年9月5日
首先提交符合 QC 标准的
2018年9月5日
首次发布 (实际的)
2018年9月7日
研究记录更新
最后更新发布 (实际的)
2019年10月18日
上次提交的符合 QC 标准的更新
2019年10月17日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
其他研究编号
- NN9423-4393
- U1111-1208-7677 (其他标识符：World Health Organization (WHO))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
NNC9204-1706的临床试验
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The First Affiliated Hospital of Xiamen University招聘中
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National Cancer Institute (NCI)主动，不招人复发性输卵管癌 | 复发性卵巢癌 | 复发性原发性腹膜癌 | 卵巢透明细胞囊腺癌 | 卵巢子宫内膜样腺癌 | 卵巢浆液性囊腺癌 | 子宫内膜透明细胞腺癌 | 子宫内膜浆液性腺癌 | IIIA 期输卵管癌 AJCC v7 | IIIA 期卵巢癌 AJCC v6 和 v7 | IIIA 期原发性腹膜癌 AJCC v7 | IIIB 期输卵管癌 AJCC v7 | IIIB 期卵巢癌 AJCC v6 和 v7 | IIIB 期原发性腹膜癌 AJCC v7 | IIIC 期输卵管癌 AJCC v7 | IIIC 期卵巢癌 AJCC v6 和 v7 | IIIC 期原发性腹膜癌 AJCC v7 | IV 期输卵管癌 AJCC v6 和 v7 | IV 期卵巢癌 AJCC v6 和 v7 | IV... 及其他条件美国
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)招聘中