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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01789086 (opens ClinicalTrials.gov in a new tab)Other idNN8022-3967Other id2012-000038-20Other idU1111-1126-8119
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
21 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
Feb 2013
Primary completion
May 2014
Completion
May 2014
First posted
11 Feb 2013 (estimated)
Last update posted
22 Dec 2016 (estimated)
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

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

    NCT01789086

    Feb 2013 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

Secondary outcomes(6)

  1. Incidence of liraglutide antibody

    Time frame · At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)

  2. At steady state at each dose step: C-trough

    Time frame · After 7, 14, 21, 28 and 35 days of treatment

  3. 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

  4. At steady-state: model-derived t½ (terminal half-life)

    Time frame · Last dose day, after up to 6 weeks' treatment

  5. At steady-state: model-derived CL/F (apparent clearance)

    Time frame · Last dose day, after up to 6 weeks' treatment

  6. At steady-state: model-derived V/F (apparent volume of distribution)

    Time frame · Last dose day, after up to 6 weeks' treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

9 results

Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12-17 Years.

Danne et al. 2017The Journal of pediatricscited by 84

PMID 27979579DOI 10.1016/j.jpeds.2016.10.076PUB-27979579

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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