NCT02527200

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2015-11-09
• Primary completion: 2020-11-04
• Completion: 2020-11-19
• First posted: 2015-08-18
• Last updated: 2023-07-06
• Results posted: 2022-02-03

Locations

32 sites across 8 countries: United States, Australia, Canada, France, Italy, Netherlands, New Zealand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study