Effect of liraglutide for weight management in children with Prader-Willi Syndrome

Effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome. A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004415-37-IT

Enrollment

Registered

2015-07-29

Start date

2015-11-10

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity (Prader-Willi syndrome) MedDRA version: 18.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Saxenda Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. Confirmed diagnosis of PWS (by genetic testing) 3. Male or female, age at the time of signing informed consent: – Part A: = 12 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus (T1DM) 2. Type 2 diabetes mellitus (T2DM) 3. Calcitonin = 50 ng/L 4. 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) 5. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC) 6. History of pancreatitis (acute or chronic) 7. 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) 8. Untreated adrenal insufficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of liraglutide versus placebo on weight loss in obese paediatric subjects with Prader-Willi syndrome (PWS) at 16 weeks and versus no treatment at 52 weeks;Secondary Objective: 1. To compare the efficacy of liraglutide versus placebo on glycaemic control in obese children and adolescents with PWS at 16 weeks and versus no treatment at 52 weeks. 2. To estimate the liraglutide steady state exposure in obese children and adolescents with PWS after 16 weeks of treatment. 3. To compare the safety of liraglutide versus placebo in obese children and adolescents with PWS at 16 weeks and versus no treatment at 52 weeks.;Primary end point(s): 1. Change in body mass index (BMI) standard deviation score (SDS) 2. Change in body mass index (BMI) standard deviation score (SDS) ;Timepoint(s) of evaluation of this end point: 1. From baseline to 16 weeks 2. From baseline to 52 weeks	—

Measure

Time frame

Main Objective: To compare the efficacy of liraglutide versus placebo on weight loss in obese paediatric subjects with Prader-Willi syndrome (PWS) at 16 weeks and versus no treatment at 52 weeks;Secondary Objective: 1. To compare the efficacy of liraglutide versus placebo on glycaemic control in obese children and adolescents with PWS at 16 weeks and versus no treatment at 52 weeks. 2. To estimate the liraglutide steady state exposure in obese children and adolescents with PWS after 16 weeks of treatment. 3. To compare the safety of liraglutide versus placebo in obese children and adolescents with PWS at 16 weeks and versus no treatment at 52 weeks.;Primary end point(s): 1. Change in body mass index (BMI) standard deviation score (SDS) 2. Change in body mass index (BMI) standard deviation score (SDS) ;Timepoint(s) of evaluation of this end point: 1. From baseline to 16 weeks 2. From baseline to 52 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. Percent of subjects achieving = 5% reduction in baseline BMI 2. Percent of subjects achieving = 10% reduction in baseline BMI Change in: 3. BMI 4. Body weight (kilogram (kg), pounds (lb) and percent (%)) 5. Hyperphagia score: a. total score and b. hyperphagic behaviour, drive and severity score 6. Systolic and diastolic blood pressure 7. Glucose metabolism: glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 1. - 2.: At weeks 16 and 52 3. - 7.: From baseline to 16 and 52 weeks	—

Measure

Time frame

Secondary end point(s): 1. Percent of subjects achieving = 5% reduction in baseline BMI 2. Percent of subjects achieving = 10% reduction in baseline BMI Change in: 3. BMI 4. Body weight (kilogram (kg), pounds (lb) and percent (%)) 5. Hyperphagia score: a. total score and b. hyperphagic behaviour, drive and severity score 6. Systolic and diastolic blood pressure 7. Glucose metabolism: glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 1. - 2.: At weeks 16 and 52 3. - 7.: From baseline to 16 and 52 weeks

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Countries

Australia, Canada, European Union, France, Italy, Netherlands, New Zealand, Turkey, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026