Phase 3 · Liraglutide

NCT02527200 trial results

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

Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks (SDS score), Week 0, Week 16. Part A: Liraglutide: -0.18; Part A: Placebo: -0.18; Part B: Liraglutide: -0.50; Part B: Placebo: -0.48; Part A+B: Liraglutide: -0.33; Part A+B: Placebo: -0.29.

Participants
56
Status
completed
Completed
2020-11-19
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02527200), updated at source Jul 6, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02527200 measured first

Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 WeeksSDS score · Week 0, Week 16 · mean
Part A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
-0.18(0.21)-0.18(0.23)-0.50(0.65)-0.48(0.39)-0.33(0.49)-0.29(0.32)
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 WeeksSDS score · Week 0, Week 52 · mean
Part A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
-0.27(0.37)-0.13(0.25)-0.79(1.21)-0.71(0.68)-0.50(0.88)-0.36(0.53)
Side effects by arm

Side effects in NCT02527200

Percent of participants affected, From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date.... The most common events the registry lists.

EventPart A: LiraglutidePart B: LiraglutidePart A: PlaceboPart B: Placebo
Any serious event5%11.8%0%14.3%
Diarrhoea50%41.2%16.7%0%
Abdominal pain30%17.6%25%0%
Influenza10%11.8%8.3%28.6%
Headache10%11.8%25%0%
Abdominal pain upper5%17.6%0%0%
Vomiting10%17.6%0%0%
Malaise5%0%16.7%0%
Constipation15%0%0%0%
Nasopharyngitis15%11.8%8.3%0%
Oropharyngeal pain10%11.8%0%14.3%
Rash0%0%0%14.3%
Sleep apnoea syndrome0%0%0%14.3%
Upper respiratory tract infection5%11.8%8.3%14.3%
Fall5%11.8%0%0%
Gastroenteritis10%11.8%0%0%
Injection site haematoma5%11.8%8.3%0%
Precocious puberty0%11.8%0%0%
Aggression10%0%0%0%
Arthropod bite10%0%0%0%
Cough10%5.9%8.3%0%
Fatigue10%5.9%0%0%
Gastrooesophageal reflux disease10%0%0%0%
Pain in extremity10%0%0%0%
Rhinitis10%5.9%0%0%
Thyroxine free decreased10%0%0%0%
Secondary outcomes

What else it measured

Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16Percentage of participants · At week 16 · number
MeasurePart A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
Yes27.88.337.557.132.426.3
No72.291.762.542.967.673.7
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52Percentage of participants · At week 52 · number
MeasurePart A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
Yes29.418.235.742.932.327.8
No70.681.864.357.167.772.2
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16Percentage of participants · At week 16 · number
MeasurePart A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
Yes006.314.32.95.3
No10010093.885.797.194.7
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52Percentage of participants · At week 52 · number
MeasurePart A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
Yes11.8014.328.612.911.1
No88.210085.771.487.188.9
Percentage of Participants With no Increase in BMI SDS at Week 16Percentage of participants · At week 16 · number
MeasurePart A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
Yes66.775.087.510076.584.2
No33.325.012.5023.515.8
Percentage of Participants With no Increase in BMI SDS at Week 52Percentage of participants · At week 52 · number
MeasurePart A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=30Part A+B: Placebon=16
Yes70.672.778.610073.381.3
No29.427.321.4026.718.8
Change in BMI From Baseline at Week 16kilogram per meter square (kg/m^2) · Week 0, week 16 · mean
Part A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
-0.9(1.4)-0.8(1.6)-1.1(1.5)-1.5(1.7)-1.0(1.4)-1.1(1.6)
Change in BMI From Baseline at Week 52kg/m^2 · Week 0, week 52 · mean
Part A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
0.8(2.2)-0.1(2.1)-0.6(3.3)-0.7(2.7)-0.7(2.7)-0.4(2.3)
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16(kilogram (kg)) · Week 0, week 16 · mean
Part A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
-1.7(3.6)-1.1(5.0)-0.6(2.2)-1.0(2.7)-1.2(3.0)-1.0(4.2)
Change in Body Weight (kg) From Baseline at Week 52kilogram · Week 0, week 52 · mean
Part A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
-0.4(6.3)1.9(6.0)3.0(6.6)2.8(5.2)1.1(6.5)2.3(5.6)
Change in Body Weight (Pounds (lb)) From Baseline at Week 16pounds (lb) · Week 0, week 16 · mean
Part A: Liraglutiden=18Part A: Placebon=12Part B: Liraglutiden=16Part B: Placebon=7Part A+B: Liraglutiden=34Part A+B: Placebon=19
-3.7(7.8)-2.4(11.0)-1.4(4.8)-2.1(5.9)-2.6(6.6)-2.3(9.2)
Change in Body Weight (lb) From Baseline at Week 52pounds · Week 0, week 52 · mean
Part A: Liraglutiden=17Part A: Placebon=11Part B: Liraglutiden=14Part B: Placebon=7Part A+B: Liraglutiden=31Part A+B: Placebon=18
-0.9(13.9)4.3(13.2)6.7(14.4)6.2(11.5)2.5(14.4)5.0(12.3)
The trial

How NCT02527200 was run

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.

  • Liraglutide
  • Placebo
Who could join the trial

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

Published papers

Papers from NCT02527200

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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