# Toward Repurposing a Commonly-Used Medication for the Treatment of Pediatric Severe Obesity

> **NIH NIH R01** · UNIVERSITY OF MINNESOTA · 2024 · $296,647

## Abstract

Project Summary/Abstract
Severe obesity in children is a highly prevalent, serious and chronic disease that directly leads to severe obesity
in adults and the subsequent enormous social and financial burden on society. Lifestyle therapy is the
cornerstone of pediatric obesity treatment, but this intervention when used alone is often insufficient for achieving
clinically significant and durable BMI reduction. Adjunct anti-obesity medications may improve outcomes of this
disease, but the pharmacological options used for obesity in children are extremely limited. Thus there is an
urgency to identify anti-obesity medications for use in the pediatric population, which are safe, effective, easily
administered and affordable. Psychostimulants, the second most commonly prescribed class of medications in
children, have a long-standing safety profile and because of their favorable effect on weight, may serve as a
useful adjunct to lifestyle therapy for the treatment of severe obesity in this population. Thus, the goal of this pilot
and feasibility clinical trial is to estimate the treatment effect of a common psychostimulant, lisdexamfetamine,
for the treatment of severe obesity in children. Specifically, 44 children ages 6 to <12 years with severe obesity
(BMI ≥120% of the 95th percentile) will be randomized, 1:1, to lisdexamfetamine plus lifestyle therapy or placebo
plus lifestyle therapy for 24 weeks of treatment. The primary outcome of the main aim will be change in BMI,
and secondary outcomes will include changes in body composition, cardiometabolic health, and quality of life.
The second aim will be to identify participant tolerability of the recommended starting dose of lisdexamfetamine
and the emergence of clinically significant increases in blood pressure and heart rate. Potential mechanisms by
which lisdexamfetamine reduces BMI will also be explored including changes in executive functioning, reward
processing, appetite, resting energy expenditure, and health behaviors (diet, eating behaviors, and physical
activity). The results of this pivotal pilot trial will directly inform the conduct of the larger, fully powered, definitive
study, which ultimately, by identifying a safe, effective and scalable treatment, will improve the outcomes of the
millions of children affected by this serious, chronic disease.

## Key facts

- **NIH application ID:** 10899577
- **Project number:** 5R01DK136538-02
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Claudia K Fox
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $296,647
- **Award type:** 5
- **Project period:** 2023-08-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10899577

## Citation

> US National Institutes of Health, RePORTER application 10899577, Toward Repurposing a Commonly-Used Medication for the Treatment of Pediatric Severe Obesity (5R01DK136538-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10899577. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*