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A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years | Clinical Trials | Clareo Health

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

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

NCT02696148•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Eligibility

Age

7 - 11 years

Sex

ALL

Healthy Volunteers

No

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

Locations (9)

Novo Nordisk Investigational Site

Anaheim, California, United States

Novo Nordisk Investigational Site

New Haven, Connecticut, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Pensacola, Florida, United States

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Novo Nordisk Investigational Site

Buffalo, New York, United States

Novo Nordisk Investigational Site

Mineola, New York, United States

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Novo Nordisk Investigational Site

Memphis, Tennessee, United States

Key Dates

Start Date

March 14, 2016

Primary Completion Date

April 13, 2017

Completion Date

April 13, 2017

Last Updated

March 18, 2019

Enrollment

24

ACTUAL participants

Conditions

Metabolism and Nutrition DisorderObesity

Interventions

liraglutide

DRUG

placebo

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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