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

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ClinicalTrials.gov Identifier: NCT02527200
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : October 2, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : August 10, 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 ]


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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


Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 31 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02527200     History of Changes
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: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to Novo Nordisk disclosure commitment on novonordisk-trials.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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