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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: placebo

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789086

NN8022-3967

2012-000038-20 (EudraCT Number)

U1111-1126-8119 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with Tanner stage 2-5 pubertal development at time of randomisation
Body Mass Index (BMI) corresponding to 30 kg/m^2 or above for adults by international cut-off points and 45 kg/m^2 or below and equal to or above 95th percentile for age and gender
Fasting plasma glucose below 7.0 mmol/L (126 mg/dL) (central laboratory analysis)

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 (glucagon-like peptide 1) receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 (dipeptidyl peptidase-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 (pharmacokinetic), PD (pharmacodynamic) and safety endpoints
Surgical treatment for obesity
Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), -triglycerides above 500 mg/dL, -calcium above UNR, -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