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HOT: LB54640 Efficacy and Safety in Hypothalamic Obesity

About this study

People with brain tumors may be treated with surgery or radiation therapy. Treatment may cause damage to a part of the brain called the hypothalamus. The hypothalamus controls a person’s hunger and weight. 

Patients with a damaged hypothalamus may develop a condition called hypothalamic obesity. This may be due to changes in how their bodies use food, increased hunger, and lower levels of physical activity. Obesity can lead to other problems such as heart disease, diabetes, and stroke.

This phase 2 study will treat people with hypothalamic obesity with the medicine LB54640. This medicine may be a new way to treat hypothalamic obesity. LB54640 is not yet approved by the United States Food and Drug Administration (FDA). We want to find out if taking this medicine is safe and if it helps control hunger and the body weight of people with hypothalamic obesity. Patients will have medical tests that include blood and urine tests. They will also fill out questionnaires.

Eligibility overview

  • Hypothalamic obesity
  • Ages 12 and up

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Overview

Full title:

A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients with Hypothalamic Obesity, with an Open-Label Extension 

Study goal:

To find out if taking the medicine LB54640 is safe and effective to control the weight and hunger of people with hypothalamic obesity.

Diagnosis:

Brain tumors

Age:

12 and up

Clinical trials categories:

Childhood Cancer Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

Learn more

 

Last Modified December 10, 2024