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

Status:	Completed
Conditions:	Obesity Weight Loss
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	7 - 11
Updated:	3/20/2019
Start Date:	March 14, 2016
End Date:	April 13, 2017

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

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

We found this trial at

sites

Novo Nordisk Investigational Site

Atlanta, Georgia 30318

from

Atlanta, GA