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

March 14, 2019 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Novo Nordisk Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Pensacola, Florida, United States, 32504
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Novo Nordisk Investigational Site
    • New York
      • Buffalo, New York, United States, 14203
        • Novo Nordisk Investigational Site
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
For subcutaneous (s.c., under the skin) injection once daily.
Experimental: Liraglutide
Drug: liraglutide
For subcutaneous (s.c., under the skin) injection once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
From 0-24 hours at steady state following the last dose (49-91 days after first dosing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Actual)

April 13, 2017

Study Completion (Actual)

April 13, 2017

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-4181
  • U1111-1162-9171 (Other Identifier: WHO)
  • 2014-004454-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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