Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region,
most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration
and as a consequence of surgery or radiation therapy. Survivors who develop obesity have
greater morbidity and mortality than normal weight survivors. Prevention and treatment of
obesity in this population is vital in order to decrease the morbidity and mortality from
diabetes, stroke and myocardial infarction.
Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2
diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and
has been shown to cause weight loss in some people. Exenatide may improve insulin
sensitivity and satiety in patients with hypothalamic obesity but without the risks of
bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to
weight loss in patients with hypothalamic obesity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Body Weight (kg)
Change in body weight from baseline to end of study
baseline and 52 weeks
Ashley Shoemaker, M.D.
United States: Food and Drug Administration
|Vanderbilt University||Nashville, Tennessee 37232-6305|