NCT02696148已完成1 期
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 years
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent
- •Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent
- •BMI (body mass index) corresponding to above or equal to 30 kg/m^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m^2 as well as BMI above or equal to 95th percentile for age and gender
排除标准
- •Subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes)
- •Subjects with confirmed bulimia nervosa disorder
- •Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 %
- •History of pancreatitis (acute or chronic)
- •Presence of severe co-morbidities as judged by the investigator
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
- •History of major depressive disorder within 2 years before randomisation
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)
次要结局
- Area under the liraglutide concentration curve(From 0-24 hours at steady state following the last dose (49-91 days after first dosing))
研究者
研究点 (1)
Loading locations...
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