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Randomized Controlled Trial
. 2024 Mar 30;190(4):257-265.
doi: 10.1093/ejendo/lvae024.

Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial

Blandine Gatta-Cherifi  1   2 , Kamel Mohammedi  1   3 , Tanguy Cariou  4 , Christine Poitou  5   6   7 , Philippe Touraine  8 , Gerald Raverot  9 , Thierry Brue  10   11 , Philippe Chanson  12 , Frédéric Illouz  13 , Solange Grunenwald  14 , Olivier Chabre  15 , Emmanuel Sonnet  16 , Thomas Cuny  11   12 , Jerôme Bertherat  17   18 , Sébastien Czernichow  19   20 , Eric Frison  5 , Antoine Tabarin  1   2
Affiliations
Randomized Controlled Trial

Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial

Blandine Gatta-Cherifi et al. Eur J Endocrinol. .

Abstract

Importance: A major issue in the management of craniopharyngioma-related obesity (CRO) is the ineffectiveness of the current therapeutic approaches.

Objective: To study the efficacy of glucagon-like peptide-1 analogs compared with placebo in adults with obesity CRO.

Design: A double-blind multicenter superiority randomized clinical in trial in two parallel arms.

Setting: Eleven French University Hospital Centers.

Participants: Adults with CRO (body mass index > 30 kg/m²) without the sign of recurrence of craniopharyngioma in the past year.

Interventions: Exenatide or placebo injected subcutaneously twice a day during 26 weeks.

Main outcomes and measures: The primary outcome was the mean change in body weight at week 26 in the intention-to-treat population. Secondary outcomes were eating behavior, calories intake, energy expenditure, cardiovascular, metabolic risk factor, quality of life, and the tolerance profile.

Results: At week 26, weight decreased from baseline by a mean of -3.8 (SD 4.3) kg for exenatide and -1.6 (3.8) kg for placebo. The adjusted mean treatment difference was -3.1 kg (95% confidence interval [CI] -7.0 to 0.7, P = 0.11). Results were compatible with a higher reduction of hunger score with exenatide compared with placebo (estimated treatment difference in change from baseline to week 26: -2.3, 95% CI -4.5 to -0.2), while all other outcomes did not significantly differ between groups. Adverse events were more common with exenatide versus placebo, and occurred in, respectively, 19 (95%) participants (108 events) and 14 (70%) participants (54 events).

Conclusions and relevance: Combined with intensive lifestyle interventions, a 26-week treatment with exenatide was not demonstrated superior to placebo to treat craniopharyngioma-related obesity.

Keywords: craniopharyngioma; glucagon-like peptide-1 analogs; hypothalamic obesity; lifestyle intervention.

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Conflict of interest statement

Conflict of interest: G.R. is on the editorial board of EJE. He was not involved in the review or editorial process for this paper, on which he is listed as an author. The other authors declare no competing interests.

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