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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696148
• Other study ID #: NN8022-4181
• Secondary ID: U1111-1162-91712
• Status: Completed
• Phase: Phase 1
• Start date: March 14, 2016
• Est. completion date: April 13, 2017

Study information

• Verified date: March 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• liraglutide
For subcutaneous (s.c., under the skin) injection once daily.
• placebo
For subcutaneous (s.c., under the skin) injection once daily.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Buffalo	New York
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Memphis	Tennessee
United States	Novo Nordisk Investigational Site	Mineola	New York
United States	Novo Nordisk Investigational Site	New Haven	Connecticut
United States	Novo Nordisk Investigational Site	Pensacola	Florida
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mastrandrea LD, Witten L, Carlsson Petri KC, Hale PM, Hedman HK, Riesenberg RA. Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmaco — View Citation

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk