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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 study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789086
First Posted: February 11, 2013
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Incidence of liraglutide antibody [ Time Frame: At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period) ]
  • At steady state at each dose step: C-trough [ Time Frame: After 7, 14, 21, 28 and 35 days of treatment ]
  • 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 ]
  • At steady-state: model-derived t½ (terminal half-life) [ Time Frame: Last dose day, after up to 6 weeks' treatment ]
  • At steady-state: model-derived CL/F (apparent clearance) [ Time Frame: Last dose day, after up to 6 weeks' treatment ]
  • At steady-state: model-derived V/F (apparent volume of distribution) [ Time Frame: Last dose day, after up to 6 weeks' treatment ]

Enrollment: 21
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide 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 Comparator: Placebo Drug: 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

  Eligibility

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789086


Locations
Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01789086     History of Changes
Other Study ID Numbers: NN8022-3967
2012-000038-20 ( EudraCT Number )
U1111-1126-8119 ( Other Identifier: WHO )
First Submitted: February 8, 2013
First Posted: February 11, 2013
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Nutrition Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists