Investigation of Pharmacokinetics, Safety and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Male Chinese Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
研究概览
简要总结
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Chinese participant.
- •Body Mass Index (BMI) between 24.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- •Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.
- •Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), domperidone or topical medication.
研究组 & 干预措施
NNC0519-0130
Participants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner.
干预措施: NNC0519-0130 (Drug)
Placebo
Participants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130.
干预措施: Placebo (Drug)
结局指标
主要结局
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
时间窗: From pre-dose up to 7 days post-dose
Measured in hours\*nanomoles per liter (h\*nmol/L).
次要结局
- Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period(From pre-dose up to 7 days post-dose)
- t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose(From pre-dose until completion of the follow-up visit (day 162))
- Number of treatment emergent adverse events (TEAEs)(From time of first dosing (day 1) until completion of the end of study visit (day 162))