Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02527200
Registration number
NCT02527200
Ethics application status
Date submitted
17/08/2015
Date registered
18/08/2015
Date last updated
6/07/2023
Titles & IDs
Public title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Query!
Scientific title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
Query!
Secondary ID [1]
0
0
2014-004415-37
Query!
Secondary ID [2]
0
0
NN8022-4179
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder
0
0
Query!
Obesity
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Mental Health
0
0
0
0
Query!
Learning disabilities
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Query!
Assessment method [1]
0
0
Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Query!
Timepoint [1]
0
0
Week 0, Week 16
Query!
Primary outcome [2]
0
0
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Query!
Assessment method [2]
0
0
Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Query!
Timepoint [2]
0
0
Week 0, Week 52
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving = 5% Reduction in Baseline BMI at Week 16
Query!
Assessment method [1]
0
0
Percentage of participants achieving more than or equal to (=) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved = 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve = 5% reduction in their baseline (week 0) BMI at week 16.
Query!
Timepoint [1]
0
0
At week 16
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving = 5% Reduction in Baseline BMI at Week 52
Query!
Assessment method [2]
0
0
Percentage of participants achieving more than or equal to (=) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved = 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve = 5% reduction in their baseline (week 0) BMI at week 52.
Query!
Timepoint [2]
0
0
At week 52
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving = 10% Reduction in Baseline BMI at Week 16
Query!
Assessment method [3]
0
0
Percentage of participants achieving more than or equal to (=) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved = 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve = 10% reduction in their baseline (week 0) BMI at week 16.
Query!
Timepoint [3]
0
0
At week 16
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving = 10% Reduction in Baseline BMI at Week 52
Query!
Assessment method [4]
0
0
Percentage of participants achieving more than or equal to (=) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved = 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve = 10% reduction in their baseline (week 0) BMI at week 52.
Query!
Timepoint [4]
0
0
At week 52
Query!
Secondary outcome [5]
0
0
Percentage of Participants With no Increase in BMI SDS at Week 16
Query!
Assessment method [5]
0
0
Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.
Query!
Timepoint [5]
0
0
At week 16
Query!
Secondary outcome [6]
0
0
Percentage of Participants With no Increase in BMI SDS at Week 52
Query!
Assessment method [6]
0
0
Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.
Query!
Timepoint [6]
0
0
At week 52
Query!
Secondary outcome [7]
0
0
Change in BMI From Baseline at Week 16
Query!
Assessment method [7]
0
0
Change in body mass index (BMI) from baseline to week 16 is presented.
Query!
Timepoint [7]
0
0
Week 0, week 16
Query!
Secondary outcome [8]
0
0
Change in BMI From Baseline at Week 52
Query!
Assessment method [8]
0
0
Change in body mass index (BMI) from baseline to week 52 is presented.
Query!
Timepoint [8]
0
0
Week 0, week 52
Query!
Secondary outcome [9]
0
0
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Query!
Assessment method [9]
0
0
Change in body weight (kg) from baseline to week 16 is presented.
Query!
Timepoint [9]
0
0
Week 0, week 16
Query!
Secondary outcome [10]
0
0
Change in Body Weight (kg) From Baseline at Week 52
Query!
Assessment method [10]
0
0
Change in body weight (kg) from baseline to week 52 is presented.
Query!
Timepoint [10]
0
0
Week 0, week 52
Query!
Secondary outcome [11]
0
0
Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Query!
Assessment method [11]
0
0
Change in body weight (lb) from baseline to week 16 is presented.
Query!
Timepoint [11]
0
0
Week 0, week 16
Query!
Secondary outcome [12]
0
0
Change in Body Weight (lb) From Baseline at Week 52
Query!
Assessment method [12]
0
0
Change in body weight (lb) from baseline to week 52 is presented.
Query!
Timepoint [12]
0
0
Week 0, week 52
Query!
Secondary outcome [13]
0
0
Change in Body Weight (Percentage [%]) From Baseline at Week 16
Query!
Assessment method [13]
0
0
Change in body weight (%) from baseline to week 16 is presented.
Query!
Timepoint [13]
0
0
Week 0, week 16
Query!
Secondary outcome [14]
0
0
Change in Body Weight (%) From Baseline at Week 52
Query!
Assessment method [14]
0
0
Change in body weight (%) from baseline to week 52 is presented.
Query!
Timepoint [14]
0
0
Week 0, week 52
Query!
Secondary outcome [15]
0
0
Change in Waist Circumference From Baseline at Week 16
Query!
Assessment method [15]
0
0
Change in waist circumference from baseline to week 16 is presented.
Query!
Timepoint [15]
0
0
Week 0, week 16
Query!
Secondary outcome [16]
0
0
Change in Waist Circumference From Baseline at Week 52
Query!
Assessment method [16]
0
0
Change in waist circumference from baseline to week 52 is presented.
Query!
Timepoint [16]
0
0
Week 0, week 52
Query!
Secondary outcome [17]
0
0
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Query!
Assessment method [17]
0
0
Change in waist-to-hip circumference ratio from baseline to week 16 is presented.
Query!
Timepoint [17]
0
0
Week 0, week 16
Query!
Secondary outcome [18]
0
0
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Query!
Assessment method [18]
0
0
Change in waist-to-hip circumference ratio from baseline to week 52 is presented.
Query!
Timepoint [18]
0
0
Week 0, week 52
Query!
Secondary outcome [19]
0
0
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Query!
Assessment method [19]
0
0
Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Query!
Timepoint [19]
0
0
Week 0, week 16
Query!
Secondary outcome [20]
0
0
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Query!
Assessment method [20]
0
0
Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Query!
Timepoint [20]
0
0
Week 0, week 52
Query!
Secondary outcome [21]
0
0
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Query!
Assessment method [21]
0
0
Change in hsCRP from baseline to week 16 is presented.
Query!
Timepoint [21]
0
0
Week 0, week 16
Query!
Secondary outcome [22]
0
0
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Query!
Assessment method [22]
0
0
Change in hsCRP from baseline to week 52 is presented.
Query!
Timepoint [22]
0
0
Week 0, week 52
Query!
Secondary outcome [23]
0
0
Change in Total Cholesterol From Baseline at Week 16
Query!
Assessment method [23]
0
0
Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [23]
0
0
Week 0, week 16
Query!
Secondary outcome [24]
0
0
Change in Total Cholesterol From Baseline at Week 52
Query!
Assessment method [24]
0
0
Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [24]
0
0
Week 0, week 52
Query!
Secondary outcome [25]
0
0
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Query!
Assessment method [25]
0
0
Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [25]
0
0
Week 0, week 16
Query!
Secondary outcome [26]
0
0
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Query!
Assessment method [26]
0
0
Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [26]
0
0
Week 0, week 52
Query!
Secondary outcome [27]
0
0
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Query!
Assessment method [27]
0
0
Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [27]
0
0
Week 0, week 16
Query!
Secondary outcome [28]
0
0
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Query!
Assessment method [28]
0
0
Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [28]
0
0
Week 0, week 52
Query!
Secondary outcome [29]
0
0
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Query!
Assessment method [29]
0
0
Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [29]
0
0
Week 0, week 16
Query!
Secondary outcome [30]
0
0
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Query!
Assessment method [30]
0
0
Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [30]
0
0
Week 0, week 52
Query!
Secondary outcome [31]
0
0
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Query!
Assessment method [31]
0
0
Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [31]
0
0
Week 0, week 16
Query!
Secondary outcome [32]
0
0
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Query!
Assessment method [32]
0
0
Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [32]
0
0
Week 0, week 52
Query!
Secondary outcome [33]
0
0
Change in Triglycerides From Baseline at Week 16
Query!
Assessment method [33]
0
0
Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [33]
0
0
Week 0, week 16
Query!
Secondary outcome [34]
0
0
Change in Triglycerides From Baseline at Week 52
Query!
Assessment method [34]
0
0
Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [34]
0
0
Week 0, week 52
Query!
Secondary outcome [35]
0
0
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Query!
Assessment method [35]
0
0
Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [35]
0
0
Week 0, week 16
Query!
Secondary outcome [36]
0
0
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Query!
Assessment method [36]
0
0
Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [36]
0
0
Week 0, week 52
Query!
Secondary outcome [37]
0
0
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Query!
Assessment method [37]
0
0
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented.
Query!
Timepoint [37]
0
0
Week 0, week 16
Query!
Secondary outcome [38]
0
0
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Query!
Assessment method [38]
0
0
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented.
Query!
Timepoint [38]
0
0
Week 0, week 52
Query!
Secondary outcome [39]
0
0
Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Query!
Assessment method [39]
0
0
Change in HbA1c from baseline to week 16 is presented.
Query!
Timepoint [39]
0
0
Week 0, week 16
Query!
Secondary outcome [40]
0
0
Change in HbA1c From Baseline at Week 52
Query!
Assessment method [40]
0
0
Change in HbA1c from baseline to week 52 is presented.
Query!
Timepoint [40]
0
0
Week 0, week 52
Query!
Secondary outcome [41]
0
0
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Query!
Assessment method [41]
0
0
Change in FPG from baseline to week 16 is presented.
Query!
Timepoint [41]
0
0
Week 0, week 16
Query!
Secondary outcome [42]
0
0
Change in FPG From Baseline at Week 52
Query!
Assessment method [42]
0
0
Change in FPG from baseline to week 52 is presented.
Query!
Timepoint [42]
0
0
Week 0, week 52
Query!
Secondary outcome [43]
0
0
Change in Fasting Insulin From Baseline at Week 16
Query!
Assessment method [43]
0
0
Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [43]
0
0
Week 0, week 16
Query!
Secondary outcome [44]
0
0
Change in Fasting Insulin From Baseline at Week 52
Query!
Assessment method [44]
0
0
Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [44]
0
0
Week 0, week 52
Query!
Secondary outcome [45]
0
0
Change in Fasting C Peptide From Baseline at Week 16
Query!
Assessment method [45]
0
0
Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline.
Query!
Timepoint [45]
0
0
Week 0, week 16
Query!
Secondary outcome [46]
0
0
Change in Fasting C Peptide From Baseline at Week 52
Query!
Assessment method [46]
0
0
Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline.
Query!
Timepoint [46]
0
0
Week 0, week 52
Query!
Secondary outcome [47]
0
0
Number of Participants in Glycaemic Category at Week 16
Query!
Assessment method [47]
0
0
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG =7.0 mmol/L (=126 mg/dL) and/or HbA1c =6.5%.
Query!
Timepoint [47]
0
0
week 16
Query!
Secondary outcome [48]
0
0
Number of Participants in Glycaemic Category at Week 52
Query!
Assessment method [48]
0
0
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG =7.0 mmol/L (=126 mg/dL) and/or HbA1c =6.5%.
Query!
Timepoint [48]
0
0
Week 52
Query!
Secondary outcome [49]
0
0
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Query!
Assessment method [49]
0
0
Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Query!
Timepoint [49]
0
0
Week 0, week 16
Query!
Secondary outcome [50]
0
0
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Query!
Assessment method [50]
0
0
Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Query!
Timepoint [50]
0
0
Week 0, week 52
Query!
Secondary outcome [51]
0
0
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Query!
Assessment method [51]
0
0
Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.
Query!
Timepoint [51]
0
0
Week 0, week 16
Query!
Secondary outcome [52]
0
0
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Query!
Assessment method [52]
0
0
Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.
Query!
Timepoint [52]
0
0
Week 0, week 52
Query!
Secondary outcome [53]
0
0
Number of Treatment Emergent Adverse Events
Query!
Assessment method [53]
0
0
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Query!
Timepoint [53]
0
0
From week 0 to week 54
Query!
Secondary outcome [54]
0
0
Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Query!
Assessment method [54]
0
0
Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Query!
Timepoint [54]
0
0
From week 0 to week 54
Query!
Secondary outcome [55]
0
0
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Query!
Assessment method [55]
0
0
Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Query!
Timepoint [55]
0
0
From week 0 to week 54
Query!
Secondary outcome [56]
0
0
Number of Participants With Occurrence of Anti-liraglutide Antibodies
Query!
Assessment method [56]
0
0
Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies.
Query!
Timepoint [56]
0
0
From week 0 to week 54
Query!
Secondary outcome [57]
0
0
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
Query!
Assessment method [57]
0
0
A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented.
Query!
Timepoint [57]
0
0
Week 0, Week 16
Query!
Secondary outcome [58]
0
0
Number of Participants With Change in ECG From Baseline at Week 52
Query!
Assessment method [58]
0
0
A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented.
Query!
Timepoint [58]
0
0
Week 0, Week 52
Query!
Secondary outcome [59]
0
0
Change in Pulse From Baseline at Week 16
Query!
Assessment method [59]
0
0
Change in pulse from baseline to week 16 is presented.
Query!
Timepoint [59]
0
0
Week 0, week 16
Query!
Secondary outcome [60]
0
0
Change in Pulse From Baseline at Week 52
Query!
Assessment method [60]
0
0
Change in pulse from baseline to week 52 is presented.
Query!
Timepoint [60]
0
0
Week 0, week 52
Query!
Secondary outcome [61]
0
0
Change in Haematology: Haemoglobin From Baseline at Week 16
Query!
Assessment method [61]
0
0
Change in haemoglobin from baseline to week 16 is presented.
Query!
Timepoint [61]
0
0
Week 0, week 16
Query!
Secondary outcome [62]
0
0
Change in Haematology: Haemoglobin From Baseline at Week 52
Query!
Assessment method [62]
0
0
Change in haemoglobin from baseline to week 52 is presented.
Query!
Timepoint [62]
0
0
Week 0, week 52
Query!
Secondary outcome [63]
0
0
Change in Haematology: Haematocrit From Baseline at Week 16
Query!
Assessment method [63]
0
0
Change in haematocrit from baseline to week 16 is presented.
Query!
Timepoint [63]
0
0
Week 0, week 16
Query!
Secondary outcome [64]
0
0
Change in Haematology: Haematocrit From Baseline at Week 52
Query!
Assessment method [64]
0
0
Change in haematocrit from baseline to week 52 is presented.
Query!
Timepoint [64]
0
0
Week 0, week 52
Query!
Secondary outcome [65]
0
0
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Query!
Assessment method [65]
0
0
Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented.
Query!
Timepoint [65]
0
0
Week 0, week 16
Query!
Secondary outcome [66]
0
0
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Query!
Assessment method [66]
0
0
Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented.
Query!
Timepoint [66]
0
0
Week 0, week 52
Query!
Secondary outcome [67]
0
0
Change in Haematology: Erythrocytes From Baseline at Week 16
Query!
Assessment method [67]
0
0
Change in erythrocytes from baseline to week 16 is presented.
Query!
Timepoint [67]
0
0
Week 0, week 16
Query!
Secondary outcome [68]
0
0
Change in Haematology: Erythrocytes From Baseline at Week 52
Query!
Assessment method [68]
0
0
Change in erythrocytes from baseline to week 52 is presented.
Query!
Timepoint [68]
0
0
Week 0, week 52
Query!
Secondary outcome [69]
0
0
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Query!
Assessment method [69]
0
0
Change in creatinine and bilirubin (total) from baseline to week 16 is presented.
Query!
Timepoint [69]
0
0
Week 0, week 16
Query!
Secondary outcome [70]
0
0
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Query!
Assessment method [70]
0
0
Change in creatinine and bilirubin (total) from baseline to week 52 is presented.
Query!
Timepoint [70]
0
0
Week 0, week 52
Query!
Secondary outcome [71]
0
0
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Query!
Assessment method [71]
0
0
Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented.
Query!
Timepoint [71]
0
0
Week 0, week 16
Query!
Secondary outcome [72]
0
0
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Query!
Assessment method [72]
0
0
Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented.
Query!
Timepoint [72]
0
0
Week 0, week 52
Query!
Secondary outcome [73]
0
0
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Query!
Assessment method [73]
0
0
Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented.
Query!
Timepoint [73]
0
0
Week 0, week 16
Query!
Secondary outcome [74]
0
0
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Query!
Assessment method [74]
0
0
Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented.
Query!
Timepoint [74]
0
0
Week 0, week 52
Query!
Secondary outcome [75]
0
0
Change in Biochemistry: Albumin From Baseline at Week 16
Query!
Assessment method [75]
0
0
Change in albumin from baseline to week 16 is presented.
Query!
Timepoint [75]
0
0
Week 0, week 16
Query!
Secondary outcome [76]
0
0
Change in Biochemistry: Albumin From Baseline at Week 52
Query!
Assessment method [76]
0
0
Change in albumin from baseline to week 52 is presented.
Query!
Timepoint [76]
0
0
Week 0, week 52
Query!
Secondary outcome [77]
0
0
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Query!
Assessment method [77]
0
0
Change in CEA serum from baseline to week 16 is presented.
Query!
Timepoint [77]
0
0
Week 0, week 16
Query!
Secondary outcome [78]
0
0
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Query!
Assessment method [78]
0
0
Change in CEA serum from baseline to week 52 is presented.
Query!
Timepoint [78]
0
0
Week 0, week 52
Query!
Secondary outcome [79]
0
0
Change in Hormone Level: Calcitonin From Baseline at Week 16
Query!
Assessment method [79]
0
0
Change in calcitonin from baseline to week 16 is presented.
Query!
Timepoint [79]
0
0
Week 0, week 16
Query!
Secondary outcome [80]
0
0
Change in Hormone Level: Calcitonin From Baseline at Week 52
Query!
Assessment method [80]
0
0
Change in calcitonin from baseline to week 52 is presented.
Query!
Timepoint [80]
0
0
Week 0, week 52
Query!
Secondary outcome [81]
0
0
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Query!
Assessment method [81]
0
0
Change in TSH and prolactin from baseline to week 16 is presented.
Query!
Timepoint [81]
0
0
Week 0, week 16
Query!
Secondary outcome [82]
0
0
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Query!
Assessment method [82]
0
0
Change in TSH and prolactin from baseline to week 52 is presented.
Query!
Timepoint [82]
0
0
Week 0, week 52
Query!
Secondary outcome [83]
0
0
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Query!
Assessment method [83]
0
0
Change in free T4 and ACTH from baseline to week 16 is presented.
Query!
Timepoint [83]
0
0
Week 0, week 16
Query!
Secondary outcome [84]
0
0
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Query!
Assessment method [84]
0
0
Change in free T4 and ACTH from baseline to week 52 is presented.
Query!
Timepoint [84]
0
0
Week 0, week 52
Query!
Secondary outcome [85]
0
0
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Query!
Assessment method [85]
0
0
Change in IGF-1 and cortisol from baseline to week 16 is presented.
Query!
Timepoint [85]
0
0
Week 0, week 16
Query!
Secondary outcome [86]
0
0
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Query!
Assessment method [86]
0
0
Change in IGF-1 and cortisol from baseline to week 52 is presented.
Query!
Timepoint [86]
0
0
Week 0, week 52
Query!
Secondary outcome [87]
0
0
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Query!
Assessment method [87]
0
0
Change in DHEAS from baseline to week 16 is presented.
Query!
Timepoint [87]
0
0
Week 0, week 16
Query!
Secondary outcome [88]
0
0
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Query!
Assessment method [88]
0
0
Change in DHEAS from baseline to week 52 is presented.
Query!
Timepoint [88]
0
0
Week 0, week 52
Query!
Secondary outcome [89]
0
0
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Query!
Assessment method [89]
0
0
Change in LH and FSH from baseline to week 16 is presented.
Query!
Timepoint [89]
0
0
Week 0, week 16
Query!
Secondary outcome [90]
0
0
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Query!
Assessment method [90]
0
0
Change in LH and FSH from baseline to week 52 is presented.
Query!
Timepoint [90]
0
0
Week 0, week 52
Query!
Secondary outcome [91]
0
0
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Query!
Assessment method [91]
0
0
Change in estradiol (only for females) from baseline to week 16 is presented.
Query!
Timepoint [91]
0
0
Week 0, week 16
Query!
Secondary outcome [92]
0
0
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Query!
Assessment method [92]
0
0
Change in estradiol (only for females) from baseline to week 52 is presented.
Query!
Timepoint [92]
0
0
Week 0, week 52
Query!
Secondary outcome [93]
0
0
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Query!
Assessment method [93]
0
0
Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Query!
Timepoint [93]
0
0
Week 0, week 16
Query!
Secondary outcome [94]
0
0
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Query!
Assessment method [94]
0
0
Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Query!
Timepoint [94]
0
0
Week 0, week 52
Query!
Secondary outcome [95]
0
0
Number of Participants With Change in Pubertal Status From Baseline at Week 16
Query!
Assessment method [95]
0
0
This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".
Query!
Timepoint [95]
0
0
Week 0, week 16
Query!
Secondary outcome [96]
0
0
Number of Participants With Change in Pubertal Status From Baseline at Week 52
Query!
Assessment method [96]
0
0
This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".
Query!
Timepoint [96]
0
0
Week 0, week 52
Query!
Secondary outcome [97]
0
0
Number of Participants With Change in Physical Examination From Baseline at Week 16
Query!
Assessment method [97]
0
0
This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Query!
Timepoint [97]
0
0
Week 0, week 16
Query!
Secondary outcome [98]
0
0
Number of Participants With Change in Physical Examination From Baseline at Week 52
Query!
Assessment method [98]
0
0
This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Query!
Timepoint [98]
0
0
Week 0, week 52
Query!
Secondary outcome [99]
0
0
Height Velocity at Week 16
Query!
Assessment method [99]
0
0
Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented.
Query!
Timepoint [99]
0
0
Week 16
Query!
Secondary outcome [100]
0
0
Height Velocity at Week 52
Query!
Assessment method [100]
0
0
Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented.
Query!
Timepoint [100]
0
0
week 52
Query!
Secondary outcome [101]
0
0
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
Query!
Assessment method [101]
0
0
C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Query!
Timepoint [101]
0
0
Week 0, week 16
Query!
Secondary outcome [102]
0
0
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
Query!
Assessment method [102]
0
0
C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Query!
Timepoint [102]
0
0
Week 0, week 52
Query!
Secondary outcome [103]
0
0
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Query!
Assessment method [103]
0
0
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Query!
Timepoint [103]
0
0
Week 0, week 16
Query!
Secondary outcome [104]
0
0
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Query!
Assessment method [104]
0
0
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Query!
Timepoint [104]
0
0
Week 0, week 52
Query!
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
Query!
Minimum age
6
Years
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/11/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/11/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
56
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Maryland
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New York
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Ohio
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Alberta
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Quebec
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
ANGERS cedex 09
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Bordeaux
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Brest
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
BRON cedex
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Haguenau
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Lille
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
MARSEILLE Cédex 05
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
MONTPELLIER cedex 05
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Nice
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Paris
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Rouen
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Toulouse cedex 9
Query!
Country [19]
0
0
Italy
Query!
State/province [19]
0
0
Fiumicino
Query!
Country [20]
0
0
Italy
Query!
State/province [20]
0
0
Milano
Query!
Country [21]
0
0
Italy
Query!
State/province [21]
0
0
Padova
Query!
Country [22]
0
0
Netherlands
Query!
State/province [22]
0
0
Rotterdam
Query!
Country [23]
0
0
New Zealand
Query!
State/province [23]
0
0
Grafton
Query!
Country [24]
0
0
Turkey
Query!
State/province [24]
0
0
Ankara
Query!
Country [25]
0
0
Turkey
Query!
State/province [25]
0
0
Istanbul
Query!
Country [26]
0
0
Turkey
Query!
State/province [26]
0
0
Samsun
Query!
Country [27]
0
0
Turkey
Query!
State/province [27]
0
0
Trabzon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02527200
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02527200
Download to PDF