Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
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
The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese. Both study medicines have been investigated on their own. The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. Participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). Participants will get 2 injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. The study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. Participants will have 28 clinic visits with the study staff and some will be overnight visits. Participants will be asked about their health, medical history and habits including mental health questionnaires.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 18 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, aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- •Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential 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) (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+Semaglutide
Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
干预措施: NNC0174-0833 (Drug)
NNC0174-0833+Semaglutide
Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
干预措施: Semaglutide (Drug)
Placebo (NNC0174-0833)+Semaglutide
Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
干预措施: Semaglutide (Drug)
Placebo (NNC0174-0833)+Semaglutide
Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
干预措施: Placebo (NNC0174-0833) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
Count of events
次要结局
- AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state(From last dose (Day 134) until end of treatment (Day 141))
- Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state(From last dose (Day 134) until end of treatment (Day 141))
- AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state(From last dose (Day 134) until end of treatment (Day 141))
- Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state(From last dose (Day 134) until end of treatment (Day 141))