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

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT02696148
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-02
• Study Start: 2016-03-14
• Primary Completion: 2017-04-13
• Study Completion: 2017-04-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Liraglutide	liraglutide	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Memphis, Tennessee, United States