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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metabolism and Nutrition Disorder, Obesity

In brief

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.

Key facts

Study ID

NCT02527200

Run by

Novo Nordisk A/S

People needed

56

Starts

2015-11-09

Expected to finish

2020-11-19

Last updated by the study team

2023-07-06

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Buffalo, New York, United States
• Novo Nordisk Investigational Site — Mineola, New York, United States
• Novo Nordisk Investigational Site — Columbus, Ohio, United States
• Novo Nordisk Investigational Site — Camperdown, New South Wales, Australia
• Novo Nordisk Investigational Site — Parkville, Victoria, Australia
• Novo Nordisk Investigational Site — Calgary, Alberta, Canada
• Novo Nordisk Investigational Site — Montreal, Quebec, Canada
• Novo Nordisk Investigational Site — Angers, France
• Novo Nordisk Investigational Site — Bordeaux, France
• Novo Nordisk Investigational Site — Brest, France
• Novo Nordisk Investigational Site — Bron, France
• Novo Nordisk Investigational Site — Haguenau, France
• Novo Nordisk Investigational Site — Lille, France
• Novo Nordisk Investigational Site — Marseille Cédex 05, France
• Novo Nordisk Investigational Site — Montpellier, France
• Novo Nordisk Investigational Site — Nice, France
• Novo Nordisk Investigational Site — Paris, France
• Novo Nordisk Investigational Site — Paris, France
• Novo Nordisk Investigational Site — Rouen, France
• Novo Nordisk Investigational Site — Toulouse, France
• Novo Nordisk Investigational Site — Fiumicino, Italy
• Novo Nordisk Investigational Site — Milan, Italy
• Novo Nordisk Investigational Site — Padova, Italy

Full record on ClinicalTrials.gov

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