EUCTR2014-004415-37-IT进行中（未招募）1 期
Effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome. A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •2. Confirmed diagnosis of PWS (by genetic testing)
- •3. Male or female, age at the time of signing informed consent:
- •– Part A: = 12 and < 18 years
- •– Part B: = 6 and < 12 years
- •4. Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B
- •5. BMI corresponding to = 30 kg/m^2 for adults by international cut-off points and = the 95th percentile for age and sex (for diagnosis of obesity)
- •6. Stable body weight during the previous 90 days before screening (< 10 kg self-reported weight change)
- •7. Testing has been performed to evaluate for adrenal insufficiency and documented in medical record
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •1. Type 1 diabetes mellitus (T1DM)
- •2. Type 2 diabetes mellitus (T2DM)
- •3. Calcitonin = 50 ng/L
- •4. No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)
- •5. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)
- •6. History of pancreatitis (acute or chronic)
- •7. Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone, liraglutide, metformin)
- •8. Untreated adrenal insufficiency
研究者
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