EUCTR2012-000038-20-DE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects aged 12-17 years (both inclusive) at time of randomisation with Tanner stage 2-5 pubertal development
- •- BMI corresponding to = 30 kg/m^2 for adults by international cut-off points and = 45 kg/m^2 and = 95th percentile for age and gender
- •- Fasting plasma glucose < 7.0 mmol/L (126 mg/dL) (central laboratory analysis)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 receptor agonists (e.g. exenatide or liraglutide or other), DPP-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, PD and safety endpoints
- •- Surgical treatment for obesity
- •- Past or current chronic or idiopathic pancreatitis, or any of the following:
- •o amylase or lipase > 2 times UNR
- •o triglycerides > 500 mg/dL
- •o calcium > UNR
- •o 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
研究者
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