Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
Pediatric severe obesity is the fastest growing obesity category in the United States, and
anti-obesity pharmacotherapies are promising adjuncts to lifestyle modification (LSM) for the
treatment of this disease. While anti-obesity pharmacotherapies have overall been associated
with mean weight loss, there is substantial variability in their individual-level
effectiveness. While some patients lose a significant amount of weight with anti-obesity
pharmacotherapies, others lose little or even gain weight.
Due to this well-recognized variability in individual-level response, the National Institutes
of Health (NIH) has recognized the importance of using precision medicine approaches in order
to optimize treatments for pediatric severe obesity. Pharmacometrics, which uses mathematical
models to study medication dose-exposure (i.e. blood drug concentrations)-response
relationships, is an emerging science that can help determine optimal dosing regimens based
upon patient-specific characteristics. Pharmacometrics quantitates the interplay between
pharmacokinetics (PK; drug dose-exposure associations) and pharmacodynamics (PD; drug
exposure-response associations). Population PK (popPK), a type of PK, can be used to
quantitate variability in drug exposure among individuals in order to help inform
recommendations on therapeutic individualization (e.g. through tailored dosing). In this
study, investigators will use popPK/PD modeling to characterize associations between
anti-obesity pharmacotherapy dose, exposure, and changes in weight and weight-related
outcomes in youth with severe obesity.
This study will focus on topiramate because this medication is commonly prescribed for weight
loss in youth with severe obesity and has been associated with highly variable
individual-level effectiveness.