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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01789086
First received: February 8, 2013
Last updated: May 28, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • At steady state at each dose step: C-trough [ Time Frame: After 7, 14, 21, 28 and 35 days of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • At steady-state: model-derived t½ (terminal half-life) [ Time Frame: Last dose day, after up to 6 weeks' treatment ] [ Designated as safety issue: No ]
  • At steady-state: model-derived CL/F (apparent clearance) [ Time Frame: Last dose day, after up to 6 weeks' treatment ] [ Designated as safety issue: No ]
  • At steady-state: model-derived V/F (apparent volume of distribution) [ Time Frame: Last dose day, after up to 6 weeks' treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789086

Locations
Germany
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01789086     History of Changes
Other Study ID Numbers: NN8022-3967, 2012-000038-20, U1111-1126-8119
Study First Received: February 8, 2013
Last Updated: May 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 29, 2014