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 is currently recruiting participants.
Verified February 2013 by Novo Nordisk
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01789086
First received: February 8, 2013
Last updated: February 13, 2013
Last verified: February 2013
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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:
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 ]
| Estimated Enrollment: | 21 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789086
Contacts
| Contact: Novo Nordisk | clinicaltrials@novonordisk.com |
Locations
| Germany | |
| Recruiting | |
| Hannover, Germany, 30173 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Birgitte Sloth | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01789086 History of Changes |
| Other Study ID Numbers: | NN8022-3967, 2012-000038-20, U1111-1126-8119, P/084/2012 |
| Study First Received: | February 8, 2013 |
| Last Updated: | February 13, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Nutrition Disorders Obesity Overnutrition Overweight Body Weight Signs and Symptoms |
Glucagon-Like Peptide 1 Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013