A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 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
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
- •Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
- •Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
- •Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- •Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
排除标准
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
- •History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
研究组 & 干预措施
NNC0194-0499
Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
干预措施: NNC0194-0499 (Drug)
Placebo
Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
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 first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
count of events
次要结局
- Change in fibrinogen(Baseline (Day -1), Follow-up (Day 112))
- Occurrence of anti-NNC0194-0499 antibodies(From baseline (Day 1) to follow-up (Day 112))
- Change in haematology(Baseline (Day -1), Follow-up (Day 112))
- Change in activated partial thromboplastin time (APTT)(Baseline (Day -1), Follow-up (Day 112))
- Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state(From last dose (Day 78, pre-dose) until the follow-up (Day 112))
- tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state(From last dose (Day 78, pre-dose) until the follow-up (Day 112))
- Change in heart rate(Baseline (Day 1), Follow-up (Day 112))
- t½,SS: the terminal serum half-life of NNC0194-0499 at steady state(From last dose (Day 78, pre-dose) until the follow-up (Day 112))
- CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state(From last dose (Day 78, pre-dose) until the follow-up (Day 112))
- Change in biochemistry(Baseline (Day -1), Follow-up (Day 112))
- Change in prothrombin time read as international normalised ratio (INR)(Baseline (Day -1), Follow-up (Day 112))
- Changes in electrocardiogram (ECG)(Baseline (Day 1), Follow-up (Day 112))
- Change in diastolic blood pressure(Baseline (Day 1), Follow-up (Day 112))
- Number of injection site reactions(From baseline (Day 1) to follow-up (Day 112))
- Change in systolic blood pressure(Baseline (Day 1), Follow-up (Day 112))