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. - NN8022-4179 (Prader-Willi Syndrome)

ovo Nordisk0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Informed consent obtained before any trial-related activities.
•- Confirmed diagnosis of PWS (by genetic testing)
•- Male or female, age at the time of signing informed consent:
•Part A: * 12 and < 18 years
•Part B: * 6 and < 12 years
•- Tanner stage 2*5 pubertal development for part A, and Tanner stage 1 for part B
•- BMI corresponding to * 30 kg/m2 for adults by international cut-off points1 and * the 95th percentile for age and sex (for diagnosis of obesity)
•- Stable body weight during the previous 90 days before screening (< 10 kg self-reported weight change)
•- Testing has been performed to evaluate for adrenal insufficiency and documented in medical record

•- Type 1 diabetes mellitus (T1DM)
•- Type 2 diabetes mellitus (T2DM)
•- Calcitonin * 50 ng/L
•- No change in treatment plan with growth hormone from randomisation to the end of the open label period (patients on GH to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)
•- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)
•- History of pancreatitis (acute or chronic)
•- 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)
•- Untreated adrenal insufficiency
•- Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominal bloating post meal, history of vomiting, severe constipation), as judged by the Investigator

发起方

ovo Nordisk