Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Prader-Willi Syndrome; Nutrition Disorders
Intervention: liraglutide; placebo
Intervention description: Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.; Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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