A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity

Abstract

Objective: Hypothalamic obesity (HO) is a common complication of hypothalamic tumors, and effective therapies are lacking. The objective of this pilot study was to investigate changes in body weight before and during treatment with exenatide.

Methods: This was a prospective, open-label, 52-week pilot study of exenatide (10 mcg b.i.d.) in adults with HO. Ten patients enrolled, and eight completed the study. Study measures included indirect calorimetry, body composition, buffet meals, diet recall, actigraphy, and hormone assays.

Results: Participants had obesity with a baseline weight of 137.2 ± 37.6 kg. Exenatide therapy was well tolerated. Change in weight with exenatide therapy was not significant (-1.4 ± 4.3 kg [95% CI -4.9 to 2.2], P = 0.40), but six out of eight completers lost weight (-6.2 to -0.2 kg). Participants reported significantly lower intake on food recall during treatment compared with baseline (7837.8 ± 2796.6 vs. 6258.4 ± 1970.7 kJ [95% CI -2915.8 to -242.6], P = 0.027), but there was no change in intake during buffet meals.

Conclusions: Significant weight loss was not observed in patients with HO treated with exenatide, but 75% of completers had stable or decreasing weight. Further studies are needed to evaluate weight loss efficacy in patients with HO.

Trial registration: ClinicalTrials.gov NCT01484873.

FIGURE 1

Change in weight from baseline in the 8 patients treated with exenatide (black, solid markers and lines) and the 2 patients who withdrew from the study after week 14 (grey, open markers and lines).