Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome

Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.

Inclusion Criteria:

• 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
• Confirmed diagnosis of PWS (Prader-Willi Syndrome) (by genetic testing)
• Male or female, age at the time of signing informed consent: - Part A: above or equal to 12 years and less than 18 years
• Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B
• BMI (body mass index) corresponding to equal or above 30 kg/m^2 for adults by international cut-off points1 and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
• Stable body weight during the previous 90 days before screening ( below 10 kg self-reported weight change)
• Testing has been performed to evaluate for adrenal insufficiency and documented in medical record

Exclusion Criteria:

• Type 1 diabetes mellitus (T1DM)
• Type 2 diabetes mellitus (T2DM)
• Calcitonin equal or above 50 ng/L
• 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)
• 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