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

NCT02527200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-07-06

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2020-11-04
Completion
2020-11-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Italy
  • Netherlands
  • New Zealand
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527200 on ClinicalTrials.gov