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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02527200




Registration number
NCT02527200
Ethics application status
Date submitted
17/08/2015
Date registered
18/08/2015
Date last updated
1/09/2020

Titles & IDs
Public title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Scientific title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
Secondary ID [1] 0 0
2014-004415-37
Secondary ID [2] 0 0
NN8022-4179
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder 0 0
Obesity 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Mental Health 0 0 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo

Experimental: Liraglutide -

Placebo Comparator: Placebo -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key 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
Minimum age
6 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
ANGERS cedex 09
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
BRON cedex
Country [11] 0 0
France
State/province [11] 0 0
Haguenau
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
MARSEILLE Cédex 05
Country [14] 0 0
France
State/province [14] 0 0
MONTPELLIER cedex 05
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Rouen
Country [18] 0 0
France
State/province [18] 0 0
Toulouse cedex 9
Country [19] 0 0
Italy
State/province [19] 0 0
Fiumicino
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Padova
Country [22] 0 0
Netherlands
State/province [22] 0 0
Rotterdam
Country [23] 0 0
New Zealand
State/province [23] 0 0
Grafton
Country [24] 0 0
Turkey
State/province [24] 0 0
Ankara
Country [25] 0 0
Turkey
State/province [25] 0 0
Istanbul
Country [26] 0 0
Turkey
State/province [26] 0 0
Samsun
Country [27] 0 0
Turkey
State/province [27] 0 0
Trabzon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02527200
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications