NCT02696148|CompletedPhase 1FDA Drug

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN8022-4181U1111-1162-91712014-004454-34

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2016

StartedMar 2016

CompletionApr 2017

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Mar 2016

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

February 26, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed

12 days until next milestone

Study Start

First participant enrolled

March 14, 2016

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2017

Completed

Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

February 26, 2016

Last Update Submit

March 14, 2019

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (1)

Number of treatment emergent adverse events
From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)

Secondary Outcomes (1)

Area under the liraglutide concentration curve
From 0-24 hours at steady state following the last dose (49-91 days after first dosing)

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

For subcutaneous (s.c., under the skin) injection once daily.

Liraglutide

placeboDRUG

For subcutaneous (s.c., under the skin) injection once daily.

Placebo

Eligibility Criteria

Age7 Years - 11 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.