A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- PART A: Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body Mass Index (BMI) between 27.0 and 39.9 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
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- •HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening
- •Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- •Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening
- •Parathyroid hormone (PTH) outside normal range at screening
- •Total calcium outside normal range at screening
- •Amylase equal to or greater than 2 times upper limit of normal at screening
- •Lipase equal to or greater than 2 times upper limit of normal at screening
- •Calcitonin equal to or greater than 50 ng/L at screening
研究组 & 干预措施
NNC0487-0111
Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)
干预措施: NNC0487-0111 (Drug)
NNC0487-0111
Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)
干预措施: Placebo (NNC0487-0111) (Drug)
Placebo
Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).
干预措施: NNC0487-0111 (Drug)
Placebo
Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).
干预措施: Placebo (NNC0487-0111) (Drug)
结局指标
主要结局
PART A: Number of treatment emergent adverse events (TEAE)
时间窗: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
Number of events
PARTS B to E: Number of treatment emergent adverse events (TEAE)
时间窗: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
Number of events
次要结局
- PART A: 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, up to Day 25)
- PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax(From pre-dose on Day 1 until completion of the end of study visit, up to Day 25)
- PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose(From pre-dose on V33D1 until end of treatment (V34) up to 9 days)
- PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax(From pre-dose on V33D1 until end of study visit (V37) up to 24 days)
- PART B to E: Relative change in body weight(From pre-dose on Day 1 until end of treatment (V34) up to Day 255)