Trial · NCT02527200
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
NCT02527200, Phase 3, Completed, Novo Nordisk A/S; results first posted 2022-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome. Trials, record NCT02527200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02527200
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
- NCT number
- NCT02527200
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 56 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- liraglutide, placebo
- First posted
- 2015-08-18
- Last updated
- 2023-07-06
- Other registries' IDs
- eudract:2014-004415-37
- Results first posted
- 2022-02-03
Source ClinicalTrials.gov
Registered outcomes106
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Week 0, Week 16 | 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. |
| Primary | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Week 0, Week 52 | 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. |
| Secondary | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | At week 16 | 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. |
| Secondary | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | At week 52 | 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. |
| Secondary | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | At week 16 | 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. |
| Secondary | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | At week 52 | 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. |
| Secondary | Percentage of Participants With no Increase in BMI SDS at Week 16 | At week 16 | 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. |
| Secondary | Percentage of Participants With no Increase in BMI SDS at Week 52 | At week 52 | 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. |
| Secondary | Change in BMI From Baseline at Week 16 | Week 0, week 16 | Change in body mass index (BMI) from baseline to week 16 is presented. |
| Secondary | Change in BMI From Baseline at Week 52 | Week 0, week 52 | Change in body mass index (BMI) from baseline to week 52 is presented. |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 registered outcomesOutcomes106
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Week 0, Week 16 | Full analysis set (FAS) which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | SDS score | MEAN |
| PRIMARY | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Week 0, Week 52 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | SDS score | MEAN |
| SECONDARY | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | At week 16 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | At week 52 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | At week 16 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | At week 52 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With no Increase in BMI SDS at Week 16 | At week 16 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With no Increase in BMI SDS at Week 52 | At week 52 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | Percentage of participants | NUMBER |
| SECONDARY | Change in BMI From Baseline at Week 16 | Week 0, week 16 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | kilogram per meter square (kg/m^2) | MEAN |
| SECONDARY | Change in BMI From Baseline at Week 52 | Week 0, week 52 | FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported. | kg/m^2 | MEAN |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 outcomesResults by group2,178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part A: Liraglutide | -0.18 | Standard Deviation 0.21 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part A: Placebo | -0.18 | Standard Deviation 0.23 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part B: Liraglutide | -0.50 | Standard Deviation 0.65 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part B: Placebo | -0.48 | Standard Deviation 0.39 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part A+B: Liraglutide | -0.33 | Standard Deviation 0.49 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Part A+B: Placebo | -0.29 | Standard Deviation 0.32 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Part A: Liraglutide | -0.27 | Standard Deviation 0.37 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Part A: Placebo | -0.13 | Standard Deviation 0.25 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Part B: Liraglutide | -0.79 | Standard Deviation 1.21 | SDS score | |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Part B: Placebo | -0.71 | Standard Deviation 0.68 | SDS score |
1 to 10 of 2,178Source ClinicalTrials.gov
See all 2,178 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Liraglutide | 20 | |
| Overall Study | STARTED | Part A: Placebo | 12 | |
| Overall Study | STARTED | Part B: Liraglutide | 17 | |
| Overall Study | STARTED | Part B: Placebo | 7 | |
| Overall Study | Safety Analysis Set (SAS) | Part A: Liraglutide | 20 | |
| Overall Study | Safety Analysis Set (SAS) | Part A: Placebo | 12 | |
| Overall Study | Safety Analysis Set (SAS) | Part B: Liraglutide | 17 | |
| Overall Study | Safety Analysis Set (SAS) | Part B: Placebo | 7 | |
| Overall Study | Full Analysis Set (FAS) | Part A: Liraglutide | 19 | |
| Overall Study | Full Analysis Set (FAS) | Part A: Placebo | 12 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events460
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Part A: Liraglutide | 0 | 20 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part B: Liraglutide | 1 | 17 | 3 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part A: Placebo | 0 | 12 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part B: Placebo | 0 | 7 | 0 |
| other | Abdominal injury | Injury, poisoning and procedural complications | Part A: Liraglutide | 1 | 20 | 1 |
| other | Abdominal injury | Injury, poisoning and procedural complications | Part B: Liraglutide | 0 | 17 | 0 |
| other | Abdominal injury | Injury, poisoning and procedural complications | Part A: Placebo | 0 | 12 | 0 |
| other | Abdominal injury | Injury, poisoning and procedural complications | Part B: Placebo | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: Liraglutide | 6 | 20 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Part B: Liraglutide | 3 | 17 | 12 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Liraglutide | 0 | 20 |
| Total, all-cause mortality | Part B: Liraglutide | 0 | 17 |
| Total, all-cause mortality | Part A: Placebo | 0 | 12 |
| Total, all-cause mortality | Part B: Placebo | 0 | 7 |
| Total, other adverse events | Part A: Liraglutide | 16 | 20 |
| Total, other adverse events | Part B: Liraglutide | 17 | 17 |
| Total, other adverse events | Part A: Placebo | 10 | 12 |
| Total, other adverse events | Part B: Placebo | 4 | 7 |
| Total, serious adverse events | Part A: Liraglutide | 1 | 20 |
| Total, serious adverse events | Part B: Liraglutide | 2 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36181471 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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