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

Study Overview
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Brief Summary
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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

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

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br> | Drug: liraglutide<br>* For subcutaneous (s.c., under the skin) injection once daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* For subcutaneous (s.c., under the skin) injection once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |