A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

Sponsor
Novo Nordisk A/S
Study ID
NCT01789086
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day
  • placebo — DRUG
    Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day

Study Details

This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.

Key Dates

Start date
Feb 28, 2013
Status verified
Dec 2016
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: From the time of first dosing (Day 0) and until completion of follow-up visit (up to 6 weeks' treatment and 5-14 days subsequent follow-up period) ]

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