Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- •Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.
研究组 & 干预措施
Active treatment NNC0247-0829
Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment
干预措施: NNC0247-0829 (Drug)
Placebo
In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo
干预措施: Placebo (NNC0247-0829) (Drug)
结局指标
主要结局
For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
时间窗: From time of first dosing (Day 1) until Day 71
Number of events
For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)
时间窗: From time of first dosing (Day 1) until Day 85
Number of events
次要结局
- For MD cohorts: Number of injection site reactions(From time of first dosing (Day 1) until Day 85)
- For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies(From time of first dosing (Day 1) until Day 85)
- For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort))
- For SD cohorts: Number of injection site reactions(From time of first dosing (Day 1) until Day 71)
- For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies(From time of first dosing (Day 1) until Day 71)