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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02696148

Enrollment

Registered

2016-03-02

Start date

2016-03-14

Completion date

2017-04-13

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

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

Interventions

DRUGliraglutide

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

7 Years to 11 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026