Obesity MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Other descriptive name: NNC90-1170
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects aged 12-17 years (both inclusive) at time of randomisation with Tanner stage 2-5 pubertal development - BMI corresponding to = 30 kg/m^2 for adults by international cut-off points and = 45 kg/m^2 and = 95th percentile for age and gender - Fasting plasma glucose =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with clinically diagnosed secondary causes of childhood obesity such as chromosomal abnormalities (e.g. Turner syndrome), syndromic obesity (e.g. Prader Willi syndrome) or endocrinologic disorders (e.g. Cushing Syndrome) - Subjects with confirmed diagnosis of bulimia - Subjects with Tanner stage 1 development (prepubertal) - Diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator - Previous treatment with a GLP-1 receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 inhibitors, orlistat or other weight lowering medication, any antipsychotic medication or systemic corticosteroids within the last 3 months - Currently using or have used within 3 months before screening for this trial: any systemic treatment that in the opinion of the investigator interferes with PK, PD and safety endpoints - Surgical treatment for obesity - Past or current chronic or idiopathic pancreatitis, or any of the following: o amylase or lipase > 2 times UNR o triglycerides > 500 mg/dL o calcium > UNR o history of gallstones (not treated by cholecystectomy) - Uncontrolled treated or untreated hypertension >99th percentile for age and gender in children - History of major depressive disorder or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) that could in the opinion of the investigator interfere with trial compliance or subject safety - Subjects with a history of suicide attempts or history of any suicidal behaviour within the past month before entry into the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of liraglutide at doses up to 3.0 mg in an obese adolescent population aged 12-17 years and Tanner stage 2-5;Secondary Objective: To assess the pharmacokinetics (PK) of liraglutide at doses up to 3.0 mg in an obese adolescent population aged 12-17 years and Tanner stage 2-5;Primary end point(s): Number of treatment emergent adverse events (TEAEs) recorded;Timepoint(s) of evaluation of this end point: From the time of first dosing and until completion of follow-up visit (up to 6 weeks treatment and 5-14 days subsequent follow-up period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: Incidence of liraglutide antibody Pharmacokinetics: 1 - At steady state at each dose step: Ctrough 2 - At steady-state : model-derived AUCt, t½, CL/F, V/F;Timepoint(s) of evaluation of this end point: Safety: At follow-up (up to 6 weeks treatment and 5-14 days subsequent follow-up period) Pharmacokinetics: 1 - After 7, 14, 21, 28 and 35 days of treatment 2 - Last dose day, after up to 6 weeks treatment | — |
Countries
Germany
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed