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A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent
  • Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent
  • BMI (body mass index) corresponding to above or equal to 30 kg/m^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m^2 as well as BMI above or equal to 95th percentile for age and gender

Exclusion Criteria:

  • Subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes)
  • Subjects with confirmed bulimia nervosa disorder
  • Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 %
  • History of pancreatitis (acute or chronic)
  • Presence of severe co-morbidities as judged by the investigator
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
  • History of major depressive disorder within 2 years before randomisation

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • 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

Secondary Outcome Measures

Area under the liraglutide concentration curve

Full Information

First Posted
February 26, 2016
Last Updated
March 14, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02696148
Brief Title
A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Official Title
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2016 (Actual)
Primary Completion Date
April 13, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 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
24 (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
For subcutaneous (s.c., under the skin) injection once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
For subcutaneous (s.c., under the skin) injection once daily.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events
Time Frame
From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)
Secondary Outcome Measure Information:
Title
Area under the liraglutide concentration curve
Time Frame
From 0-24 hours at steady state following the last dose (49-91 days after first dosing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent BMI (body mass index) corresponding to above or equal to 30 kg/m^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m^2 as well as BMI above or equal to 95th percentile for age and gender Exclusion Criteria: Subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes) Subjects with confirmed bulimia nervosa disorder Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 % History of pancreatitis (acute or chronic) Presence of severe co-morbidities as judged by the investigator Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) History of major depressive disorder within 2 years before randomisation
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Citations:
PubMed Identifier
30653847
Citation
Mastrandrea LD, Witten L, Carlsson Petri KC, Hale PM, Hedman HK, Riesenberg RA. Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Pediatr Obes. 2019 May;14(5):e12495. doi: 10.1111/ijpo.12495. Epub 2019 Jan 17.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

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