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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02696148 (opens ClinicalTrials.gov in a new tab)Other idNN8022-4181Other idU1111-1162-9171Other id2014-004454-34Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
14 Mar 2016
Primary completion
13 Apr 2017
Completion
13 Apr 2017
First posted
2 Mar 2016 (estimated)
Last update posted
18 Mar 2019
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 1

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

    NCT02696148

    14 Mar 2016 to 13 Apr 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(1)

  1. 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

7 results

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.

Mastrandrea et al. 2019Pediatric obesitycited by 63

PMID 30653847PMC6590663DOI 10.1111/ijpo.12495PUB-30653847

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 7 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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