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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02527200
Recruitment Status : Active, not recruiting
First Posted : August 18, 2015
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
Actual Study Start Date : November 9, 2015
Estimated Primary Completion Date : July 27, 2020
Estimated Study Completion Date : November 25, 2020


Arm Intervention/treatment
Experimental: Liraglutide Drug: 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 Comparator: Placebo Drug: 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.




Primary Outcome Measures :
  1. Change in body mass index (BMI) standard deviation score (SDS) [ Time Frame: Week 0, Week 16 ]
  2. Change in body mass index (BMI) standard deviation score (SDS) [ Time Frame: Week 0, Week 52 ]

Secondary Outcome Measures :
  1. Percent of subjects achieving equal to or above 5% reduction in baseline BMI [ Time Frame: At weeks 16 and 52 ]
  2. Percent of subjects achieving equal or above 10% reduction in baseline BMI [ Time Frame: At weeks 16 and 52 ]
  3. Change in body mass index (BMI) [ Time Frame: Week 0, Week 16 ]
  4. Change in body mass index (BMI) [ Time Frame: Week 0, Week 52 ]
  5. Body weight (kilogram (kg), pounds (lb) and percent (%)) [ Time Frame: Week 0, Week 16 ]
  6. Body weight (kilogram (kg), pounds (lb) and percent (%)) [ Time Frame: Week 0, Week 52 ]
  7. Hyperphagia total score [ Time Frame: Week 0, Week 16 ]
  8. Hyperphagia total score [ Time Frame: Week 0, Week 52 ]
  9. hyperphagic behaviour score [ Time Frame: Week 0, Week 16 ]
  10. hyperphagic behaviour score [ Time Frame: Week 0, Week 52 ]
  11. Hyperphagia drive score [ Time Frame: Week 0, Week 16 ]
  12. Hyperphagia drive score [ Time Frame: Week 0, Week 52 ]
  13. Hyperphagia severity score [ Time Frame: Week 0, Week 16 ]
  14. Hyperphagia severity score [ Time Frame: Week 0, Week 52 ]
  15. Change in Systolic and diastolic blood pressure [ Time Frame: Week 0, Week 16 ]
  16. Change in Systolic and diastolic blood pressure [ Time Frame: Week 0, Week 52 ]
  17. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 16 ]
  18. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 52 ]
  19. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 16 ]
  20. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527200


Locations
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United States, California
Novo Nordisk Investigational Site
Santa Monica, California, United States, 90404
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14203
Novo Nordisk Investigational Site
Mineola, New York, United States, 11501
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43235
Australia, New South Wales
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Novo Nordisk Investigational Site
Parkville, Victoria, Australia, 3052
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T3B 6A8
Canada, Quebec
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H4A 3J1
France
Novo Nordisk Investigational Site
ANGERS cedex 09, France, 49033
Novo Nordisk Investigational Site
Bordeaux, France, 33076
Novo Nordisk Investigational Site
Brest, France, 29609
Novo Nordisk Investigational Site
BRON cedex, France, 69677
Novo Nordisk Investigational Site
Haguenau, France, 67504
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
MARSEILLE Cédex 05, France, 13385
Novo Nordisk Investigational Site
MONTPELLIER cedex 05, France, 34295
Novo Nordisk Investigational Site
Nice, France, 06200
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Paris, France
Novo Nordisk Investigational Site
Rouen, France, 76031
Novo Nordisk Investigational Site
Toulouse cedex 9, France, 31059
Italy
Novo Nordisk Investigational Site
Fiumicino, Italy, 00050
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Padova, Italy, 35128
Netherlands
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 CN
New Zealand
Novo Nordisk Investigational Site
Grafton, New Zealand, 1023
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06010
Novo Nordisk Investigational Site
Istanbul, Turkey, 34093
Novo Nordisk Investigational Site
Istanbul, Turkey, 34890
Novo Nordisk Investigational Site
Samsun, Turkey, 55139
Novo Nordisk Investigational Site
Trabzon, Turkey, 61080
Sponsors and Collaborators
Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02527200    
Other Study ID Numbers: NN8022-4179
2014-004415-37 ( EudraCT Number )
U1111-1162-7884 ( Other Identifier: WHO )
NL54145.078.15 ( Other Identifier: CCMO )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Nutrition Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists