Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Number of Adverse Events (AEs)
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 people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female of non-childbearing potential, or male.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 27.0 and 44.9 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 to be otherwise healthy 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, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- •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, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
研究组 & 干预措施
Arm 4: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.
干预措施: NNC0519-0130 (Drug)
Arm 1: NNC0519-0130
Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase.
干预措施: NNC0519-0130 (Drug)
Arm 2: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase.
干预措施: NNC0519-0130 (Drug)
Arm 3: NNC0519-0130
Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase.
干预措施: NNC0519-0130 (Drug)
结局指标
主要结局
Number of Adverse Events (AEs)
时间窗: From randomisation (week 0) to week 18
Measured as number of events.
次要结局
未报告次要终点