{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T15:02:05Z","timestamp":1785769325277,"version":"3.56.0"},"reference-count":50,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,16]],"date-time":"2023-08-16T00:00:00Z","timestamp":1692144000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl J Eating Disorders"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This Phase II, placebo\u2010controlled, double\u2010blind study investigated the efficacy, safety, and tolerability of nivasorexant in the treatment of adults with moderate to severe binge\u2010eating disorder (BED).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults meeting the DSM\u20105 BED criteria were randomized 1:1 to placebo or nivasorexant (100\u2009mg b.i.d.). The primary endpoint was the change from baseline to Week 12 in the number of binge eating (BE) days per week. Exploratory efficacy endpoints included cessation of BE in the last 4\u2009weeks of treatment; and change from baseline to Week 12 in the number of BE episodes\/week, the clinician global impression (CGI) of change, the Yale\u2010Brown Obsessive\u2010Compulsive Scale modified for BE, and the Hamilton rating scale for depression (HAMD\u201017). Key safety outcomes included treatment\u2010emergent adverse events (TEAEs) and adverse events of special interest (i.e., somnolence and fatigue).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixty\u2010eight participants were randomized to each treatment arm. The change from baseline to Week 12 in the number of BE days\/week was the same for placebo (least squares mean [LSM]: \u22122.93) and nivasorexant (LSM: \u22122.93), with no difference between the treatment groups (LSM difference\u2009=\u2009.000 [95% confidence interval (CI): \u2212.69, .69], <jats:italic>p<\/jats:italic>\u2009=\u2009.9992). Furthermore, no differences between treatment groups were observed in the exploratory efficacy endpoints. Nivasorexant was well tolerated; the overall incidence of TEAEs was balanced between treatment groups, and the frequency of somnolence and fatigue in the nivasorexant group were similar to placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>In this proof\u2010of\u2010concept study, 100\u2009mg b.i.d. nivasorexant did not improve BE in adults with moderate to severe BED.<\/jats:p><\/jats:sec><jats:sec><jats:title>Public Significance<\/jats:title><jats:p>The results of this Phase II study indicate that nivasorexant was well tolerated in adults with BED, but did not improve binge eating behavior over placebo. Further research is needed to improve our understanding of the role of the orexin\u20101 receptor in BED.<\/jats:p><\/jats:sec>","DOI":"10.1002\/eat.24039","type":"journal-article","created":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T05:35:25Z","timestamp":1692423325000},"page":"2120-2130","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Efficacy, safety, and tolerability of nivasorexant in adults with binge\u2010eating disorder: A randomized, Phase <scp>II<\/scp> proof of concept trial"],"prefix":"10.1002","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8879-0865","authenticated-orcid":false,"given":"Susan L.","family":"McElroy","sequence":"first","affiliation":[{"name":"Lindner Center of HOPE, Department of Psychiatry &amp; Behavioral Neuroscience University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Preciosa M.","family":"Coloma","sequence":"additional","affiliation":[{"name":"Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Berger","sequence":"additional","affiliation":[{"name":"Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8141-0698","authenticated-orcid":false,"given":"Anna I.","family":"Guerdjikova","sequence":"additional","affiliation":[{"name":"Lindner Center of HOPE, Department of Psychiatry &amp; Behavioral Neuroscience University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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