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