Liraglutide pharmacokinetics and exposure-response in adolescents with obesity

Abstract

Background: Obesity in adolescence presents a major public health challenge, often leading to obesity in adulthood with associated chronic disease.

Objectives: This study aimed to perform a population pharmacokinetic and exposure-response analysis of liraglutide by meta-analysis of data from trials conducted in children, adolescents and adults with obesity.

Methods: The population pharmacokinetic analysis investigated the effect of covariates body weight, age group (children, adolescents and adults) and sex on liraglutide exposure in adolescents compared with previous results in adults. The exposure-response relationship of liraglutide for the change from baseline in body mass index standard deviation score (BMI SDS) was evaluated in adolescents and compared to that in adults.

Results: Body weight was the main covariate affecting liraglutide exposure, with lower exposures at higher body weights, whereas age group was of no importance and sex was of little importance. An exposure-response relationship was demonstrated for liraglutide in both adolescents and adults as the decrease in BMI SDS from baseline increased in an exposure-dependent manner with increasing liraglutide exposure.

Conclusions: The population pharmacokinetic analysis supported similar liraglutide exposures in adolescents and adults; body weight was the most important covariate affecting exposure. An exposure-response relationship was established for liraglutide.

Keywords: GLP-1; adolescents; clinical trial; liraglutide; paediatric; pharmacokinetics.