Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
NCT ID: NCT02527200
Last Updated: 2023-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2015-11-09
2020-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide
liraglutide
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.
Placebo
placebo
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.
Interventions
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liraglutide
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.
placebo
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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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
Padua, , Italy
Novo Nordisk Investigational Site
Rotterdam, , Netherlands
Novo Nordisk Investigational Site
Grafton, , New Zealand
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Samsun, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Trabzon, , Turkey (Türkiye)
Countries
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References
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Diene G, Angulo M, Hale PM, Jepsen CH, Hofman PL, Hokken-Koelega A, Ramesh C, Turan S, Tauber M. Liraglutide for Weight Management in Children and Adolescents With Prader-Willi Syndrome and Obesity. J Clin Endocrinol Metab. 2022 Dec 17;108(1):4-12. doi: 10.1210/clinem/dgac549.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-004415-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1162-7884
Identifier Type: OTHER
Identifier Source: secondary_id
NL54145.078.15
Identifier Type: OTHER
Identifier Source: secondary_id
NN8022-4179
Identifier Type: -
Identifier Source: org_study_id
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