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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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

liraglutide

placebo

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Incidence of liraglutide antibody

At steady state at each dose step: C-trough

At steady-state: model-derived area under the liraglutide concentration curve over the dosing

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

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

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

Full Information

NCT ID

NCT01789086

First Posted

February 8, 2013

Last Updated

December 21, 2016

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01789086

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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 Outcome Measure Information:

Title

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 Measure Information:

Title

Incidence of liraglutide antibody

Time Frame

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

Title

At steady state at each dose step: C-trough

Time Frame

After 7, 14, 21, 28 and 35 days of treatment

Title

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

Title

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

Time Frame

Last dose day, after up to 6 weeks' treatment

Title

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

Time Frame

Last dose day, after up to 6 weeks' treatment

Title

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

Time Frame

Last dose day, after up to 6 weeks' treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27979579

Citation

Danne T, Biester T, Kapitzke K, Jacobsen SH, Jacobsen LV, Petri KCC, Hale PM, Kordonouri O. 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. J Pediatr. 2017 Feb;181:146-153.e3. doi: 10.1016/j.jpeds.2016.10.076. Epub 2016 Dec 13.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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