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NCT04986631 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
A Early Phase 1 study of Obesity, Childhood, sponsored by University of Minnesota.
- Active
- Registry status
- Early Phase 1
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT04986631 is a Early Phase 1 study of Obesity, Childhood that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 62 participants, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04986631, a Early Phase 1 study of Obesity, Childhood, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Topiramate Tablets
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2026-03-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04986631
The ClinicalTrials.gov registry entry for NCT04986631 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (82% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Topiramate Tablets is the first listed.
NCT04986631 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04986631 about?
NCT04986631 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP". 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,...
What is the current status of trial NCT04986631?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 62 participants. The study started on 2022-04-04. Estimated completion is 2026-03-12.
What conditions does trial NCT04986631 study?
This clinical trial studies the following conditions: Obesity, Childhood.
What interventions are being tested in trial NCT04986631?
The interventions under investigation include: Topiramate Tablets (DRUG).
Who is sponsoring clinical trial NCT04986631?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04986631 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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