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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: placebo

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02527200

NL54145.078.15 (Other Identifier)

U1111-1162-7884 (Other Identifier)

NN8022-4179

2014-004415-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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