NCT01789086已完成1 期
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 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
- 21
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Tanner stage 2-5 pubertal development at time of randomisation
- •Body Mass Index (BMI) corresponding to 30 kg/m^2 or above for adults by international cut-off points and 45 kg/m^2 or below and equal to or above 95th percentile for age and gender
- •Fasting plasma glucose below 7.0 mmol/L (126 mg/dL) (central laboratory analysis)
排除标准
- •Subjects with clinically diagnosed secondary causes of childhood obesity such as chromosomal abnormalities (e.g. Turner syndrome), syndromic obesity (e.g. Prader Willi syndrome) or endocrinologic disorders (e.g. Cushing Syndrome)
- •Subjects with confirmed diagnosis of bulimia
- •Subjects with Tanner stage 1 development (prepubertal)
- •Diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator
- •Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 (dipeptidyl peptidase-4) inhibitors, orlistat or other weight lowering medication, any antipsychotic medication or systemic corticosteroids within the last 3 months
- •Currently using or have used within 3 months before screening for this trial: any systemic treatment that in the opinion of the investigator interferes with PK (pharmacokinetic), PD (pharmacodynamic) and safety endpoints
- •Surgical treatment for obesity
- •Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), -triglycerides above 500 mg/dL, -calcium above UNR, -history of gallstones (not treated by cholecystectomy)
- •Uncontrolled treated or untreated hypertension 99th percentile for age and gender in children
- •History of major depressive disorder or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) that could in the opinion of the investigator interfere with trial compliance or subject safety
- •Subjects with a history of suicide attempts or history of any suicidal behaviour within the past month before entry into the trial
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 (TEAEs)
时间窗: From the time of first dosing (Day 0) and until completion of follow-up visit (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)
次要结局
- At steady-state: model-derived area under the liraglutide concentration curve over the dosing(Last dose day, after up to 6 weeks' treatment)
- At steady-state: model-derived t½ (terminal half-life)(Last dose day, after up to 6 weeks' treatment)
- Incidence of liraglutide antibody(At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period))
- At steady state at each dose step: C-trough(After 7, 14, 21, 28 and 35 days of treatment)
- At steady-state: model-derived V/F (apparent volume of distribution)(Last dose day, after up to 6 weeks' treatment)
- At steady-state: model-derived CL/F (apparent clearance)(Last dose day, after up to 6 weeks' treatment)
研究者
研究点 (1)
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