{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:47:27Z","timestamp":1787510847371,"version":"build-2736575974"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T00:00:00Z","timestamp":1738627200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Obesity"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The objective of this study was to investigate the efficacy and safety of the Epitomee capsule versus placebo as an adjunct to high\u2010intensity lifestyle intervention in participants with overweight or obesity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial (RESET) was a prospective, double\u2010blind, placebo\u2010controlled pivotal trial in adults with baseline BMI of 27.0 to 40.0\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      . The co\u2010primary endpoints at week 24 were percentage change from baseline in body weight for the Epitomee and placebo groups and proportion of Epitomee\u2010treated patients achieving \u22655% weight loss compared with a 35% threshold. The primary safety endpoint was the incidence of device\u2010related serious adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 138 participants received Epitomee and 141 received placebo. Mean (SD) change in body weight from baseline was \u22126.6%\u2009(6.5%) with Epitomee and\u2009\u22124.6%\u2009(\u20094.7%) with placebo; least\u2010squares means were\u2009\u22126.1%\u2009(0.6%) and \u22124.2%\u2009(0.6%), respectively (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0054). Fifty\u2010six percent of Epitomee\u2010treated participants attained \u22655% weight loss from baseline, which was significantly greater than the 35% predefined threshold (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Twenty\u2010seven percent of Epitomee\u2010treated and eleven percent of placebo\u2010treated participants achieved \u226510% weight loss. Adverse event rates were similar between the groups. No device\u2010related serious adverse events occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Epitomee capsule is a safe and efficacious nonpharmacological option for weight management with potential broad application in participants with overweight or obesity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/oby.24240","type":"journal-article","created":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T22:05:06Z","timestamp":1738706706000},"page":"500-511","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized\n                    <scp>RESET<\/scp>\n                    study"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1643-6795","authenticated-orcid":false,"given":"Jamy D.","family":"Ard","sequence":"first","affiliation":[{"name":"Department of Epidemiology and Prevention and Department of Medicine Wake Forest University School of Medicine  Winston\u2010Salem North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna H.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Pennington Biomedical Research Center Louisiana State University  Baton Rouge Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0388-4046","authenticated-orcid":false,"given":"Patrick M.","family":"O'Neil","sequence":"additional","affiliation":[{"name":"Weight Management Center, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina  Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1380-3705","authenticated-orcid":false,"given":"Robert F.","family":"Kushner","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Endocrinology, Metabolism, and Molecular Medicine Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly R.","family":"Wyatt","sequence":"additional","affiliation":[{"name":"Department of Nutrition Sciences The University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9912-1408","authenticated-orcid":false,"given":"Harold E.","family":"Bays","sequence":"additional","affiliation":[{"name":"Louisville Metabolic and Atherosclerosis Research Center  Louisville Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1766-6111","authenticated-orcid":false,"given":"Frank L.","family":"Greenway","sequence":"additional","affiliation":[{"name":"Pennington Biomedical Research Center Louisiana State University  Baton Rouge Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6800-9368","authenticated-orcid":false,"given":"John M.","family":"Jakicic","sequence":"additional","affiliation":[{"name":"Division of Physical Activity and Weight Management, Department of Internal Medicine University of Kansas Medical Center  Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Leonard","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Perelman School of Medicine at the University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yael","family":"Kenan","sequence":"additional","affiliation":[{"name":"Epitomee Medical Ltd.  Caesarea Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eti","family":"Ganon\u2010Elazar","sequence":"additional","affiliation":[{"name":"Epitomee Medical Ltd.  Caesarea Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0438-4609","authenticated-orcid":false,"given":"Thomas A.","family":"Wadden","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Perelman School of Medicine at the University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,4]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"World Health Organization.Obesity and overweight. 2024.https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/obesity-and-overweight"},{"key":"e_1_2_11_3_1","unstructured":"World Health Organization.Obesity: preventing and managing the global epidemic: report of a WHO consultation. 2000."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1614362"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000973"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurjpc\/zwac187"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1042\/CS20160006"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437739.71477.ee"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2032183"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1411892"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2019.00155"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)11509-4"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.19574"},{"issue":"8","key":"e_1_2_11_14_1","article-title":"Surgery for weight loss in adults","volume":"2014","author":"Colquitt JL","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/osp4.343"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.obpill.2023.100094"},{"issue":"2","key":"e_1_2_11_17_1","first-page":"26","article-title":"Oral\u2010053. 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