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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT02527200
Phase
PHASE3
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    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.
  • placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 9, 2015
Status verified
Jul 2023
Primary completion
Nov 4, 2020
Completion
Nov 19, 2020

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks [ Time Frame: Week 0, Week 16 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteSanta MonicaCalifornia90404-
Novo Nordisk Investigational SiteBaltimoreMaryland21229-
Novo Nordisk Investigational SiteBuffaloNew York14203-
Novo Nordisk Investigational SiteMineolaNew York11501-
Novo Nordisk Investigational SiteColumbusOhio43235-

Find similar trials in Santa Monica, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Santa Monica, CANovo Nordisk Investigational Site· Baltimore, MDNovo Nordisk Investigational Site· Buffalo, NYNovo Nordisk Investigational Site· Mineola, NYNovo Nordisk Investigational Site· Columbus, OH

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