An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 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 study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 7 months. Participants will have 27 visits to the clinic.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 19-55 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. Obesity should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) 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 subjects who are not 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 less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), 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
NNC0165-1562 + Semaglutide
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
干预措施: NNC0165-1562 (Drug)
NNC0165-1562 + Semaglutide
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
干预措施: Semaglutide (Drug)
NNC0165-1562 + Semaglutide
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
干预措施: Placebo (NNC0165-1562) (Drug)
Placebo (NNC0165-1562) + Semaglutide
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
干预措施: NNC0165-1562 (Drug)
Placebo (NNC0165-1562) + Semaglutide
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
干预措施: Semaglutide (Drug)
Placebo (NNC0165-1562) + Semaglutide
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
干预措施: Placebo (NNC0165-1562) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: Week 0-25
Count of adverse events.
次要结局
- AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state(Week 19 (day 134) to week 20 (day 141))
- AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state(Week 19 (day 134) to week 20 (day 141))