The prevalence of severe pediatric obesity is on the rise and youth with this condition are
at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and
type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug
Administration (FDA) for the treatment of seizures in adults and children, is associated with
weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults
have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However,
the weight loss effect of topiramate has never been evaluated among children and adolescents.
Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of
topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with
severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed
by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline
and 28 weeks compared to meal replacement therapy followed by placebo.
Phase:
Phase 2
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute