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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789086
• Other study ID #: NN8022-3967
• Secondary ID: 2012-000038-20U1
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2013
• Last updated: December 21, 2016
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• liraglutide
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
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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Danne T, Biester T, Kapitzke K, Jacobsen SH, Jacobsen LV, Petri KC, Hale PM, Kordonouri O. Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokineti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)		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)	No
Secondary	Incidence of liraglutide antibody		At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)	No
Secondary	At steady state at each dose step: C-trough		After 7, 14, 21, 28 and 35 days of treatment	No
Secondary	At steady-state: model-derived area under the liraglutide concentration curve over the dosing		Last dose day, after up to 6 weeks' treatment	No
Secondary	At steady-state: model-derived t½ (terminal half-life)		Last dose day, after up to 6 weeks' treatment	No
Secondary	At steady-state: model-derived CL/F (apparent clearance)		Last dose day, after up to 6 weeks' treatment	No
Secondary	At steady-state: model-derived V/F (apparent volume of distribution)		Last dose day, after up to 6 weeks' treatment	No

External Links

•   Clinical Trials at Novo Nordisk