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Completed

NCT Number: NCT01789086

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

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.

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Drug

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

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2013
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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