Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Doses of Subcutaneous NNC0487-0111 in Chinese Participants With Overweight or Obesity.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 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 testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 kg at screening.
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Any condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
- •Any laboratory safety parameters at screening outside the below laboratory ranges:
- •Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per mililiter (ng/mL) [30 nanometer (nM)] at screening
- •Parathyroid hormone (PTH) outside normal range at screening
- •Total calcium outside normal range at screening
- •Amylase ≥ 2 times upper limit of normal at screening
- •Lipase ≥ 2 times upper limit of normal at screening
- •Calcitonin ≥ 50 picogram per mililiter (pg/mL) at screening
研究组 & 干预措施
Cohort A1
Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo.
干预措施: NNC0487-0111 A (Drug)
Cohort A1
Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo.
干预措施: Placebo A (Drug)
Cohort A3
Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo.
干预措施: NNC0487-0111 A (Drug)
Cohort A2
Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo.
干预措施: NNC0487-0111 A (Drug)
Cohort A2
Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo.
干预措施: Placebo A (Drug)
Cohort A3
Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo.
干预措施: Placebo A (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)
Number of events
次要结局
- AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose on Day 1 until completion of the end of study visit (Day 23))
- Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose(From pre-dose on Day 1 until completion of the end of study visit (Day 23))
- tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose(From pre-dose on Day 1 until completion of the end of study visit (Day 23))
- t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose(From pre-dose on Day 1 until completion of the end of study visit (Day 23))
- Relative change in body weight(From baseline Day 1 until completion of the end of study visit (Day 23))
- Change in fasting plasma glucose(From baseline Day 1 until completion of the end of study visit (Day 23))