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



Status:Recruiting
Conditions:Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:6 - 18
Updated:10/4/2018
Start Date:November 9, 2015
End Date:August 10, 2020
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com

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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
We found this trial at
5
sites
Columbus, Ohio 43205
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Baltimore, Maryland 21229
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Baltimore, MD
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Buffalo, New York 14222
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Buffalo, NY
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Camperdown, New South Wales
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Camperdown,
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Mineola, New York 11501
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Mineola, NY
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