A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Part A: Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex at birth)
- •Aged 19-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 27.0 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 and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
- •Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
- •Calcitonin >= 50 nanogram per liter (ng/L) at screening
研究组 & 干预措施
Part A: Single ascending dose (SAD)
Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.
干预措施: NNC0662-0419 (Drug)
Part A: Single ascending dose (SAD)
Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.
干预措施: Placebo (NNC0662-0419) (Other)
Part B: Multiple ascending dose (MAD)
Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.
干预措施: NNC0662-0419 (Drug)
Part B: Multiple ascending dose (MAD)
Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.
干预措施: Placebo (NNC0662-0419) (Other)
结局指标
主要结局
Part A: Number of treatment emergent adverse events (TEAE)
时间窗: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)
Number of events
Part B: Number of treatment-emergent adverse events (TEAE)
时间窗: From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)
Number of events
次要结局
- Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve(From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks))
- Part A: Cmax; the maximum plasma concentration of NNC0662-0419(From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks))
- Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve(From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks))
- Part B: Cmax; the maximum plasma concentration of NNC0662-0419(From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks))