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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
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
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
Novo Nordisk Investigational Site
Hanover, Germany
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)
Incidence of liraglutide antibody
Time frame: At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)
At steady state at each dose step: C-trough
Time frame: After 7, 14, 21, 28 and 35 days of treatment
At steady-state: model-derived area under the liraglutide concentration curve over the dosing
Time frame: Last dose day, after up to 6 weeks' treatment
At steady-state: model-derived t½ (terminal half-life)
Time frame: Last dose day, after up to 6 weeks' treatment
At steady-state: model-derived CL/F (apparent clearance)
Time frame: Last dose day, after up to 6 weeks' treatment
At steady-state: model-derived V/F (apparent volume of distribution)
Time frame: Last dose day, after up to 6 weeks' treatment
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