{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T19:55:50Z","timestamp":1792007750614,"version":"4.4.0"},"reference-count":28,"publisher":"Wiley","issue":"11-12","license":[{"start":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T00:00:00Z","timestamp":1729036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Semaglutide, a glucagon\u2010like peptide\u20101 receptor agonist, has demonstrated potential beneficial effects in metabolic dysfunction\u2010associated steatohepatitis (MASH).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To describe the trial design and baseline characteristics of the \u2018Effect of Semaglutide in Subjects with Non\u2010cirrhotic Non\u2010alcoholic Steatohepatitis\u2019 (ESSENCE) trial (NCT04822181).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ESSENCE is a two\u2010part, phase 3, randomised, multicentre trial evaluating the effect of subcutaneous semaglutide 2.4\u2009mg in participants with biopsy\u2010proven MASH and fibrosis stage 2 or 3. The primary objective of Part 1 is to demonstrate that semaglutide improves liver histology compared with placebo. The two primary endpoints are: resolution of steatohepatitis and no worsening of liver fibrosis, and improvement in liver fibrosis and no worsening of steatohepatitis. The Part 2 objective is based on clinical outcomes. The current work reports baseline characteristics of the first 800 randomised participants which includes demographics, laboratory parameters, liver histology, non\u2010invasive tests and presence of metabolic dysfunction\u2010associated steatotic liver disease (MASLD) cardiometabolic criteria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 800 participants, 250 (31.3%) had fibrosis stage 2 and 550 (68.8%) had fibrosis stage 3. In the overall population, mean (standard deviation [SD]) age was 56 (11.6) years, 57.1% were female, mean (SD) body mass index was 34.6 (7.2) kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , 55.5% had type 2 diabetes and &gt;\u200999% had at least one MASLD cardiometabolic criterion according to the published definition.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The ESSENCE baseline population includes participants with clinically significant fibrosis stages 2 and 3. Although MASLD cardiometabolic criteria were not a requirement for study enrolment, almost all participants (&gt;\u200999%) had at least one MASLD cardiometabolic criterion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>NCT04822181<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.18331","type":"journal-article","created":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T10:49:40Z","timestamp":1729075780000},"page":"1525-1533","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":149,"title":["Semaglutide 2.4\u2009mg in Participants With Metabolic Dysfunction\u2010Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3\n                    <scp>ESSENCE<\/scp>\n                    Trial"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6085-3652","authenticated-orcid":false,"given":"Philip N.","family":"Newsome","sequence":"first","affiliation":[{"name":"Roger Williams Institute of Liver Studies, Faculty of Life Sciences and Medicine King's College London and King's College Hospital  London UK"},{"name":"College of Medical and Dental Sciences University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8682-5748","authenticated-orcid":false,"given":"Arun J.","family":"Sanyal","sequence":"additional","affiliation":[{"name":"VCU School of Medicine Stravitz\u2010Sanyal Institute for Liver Disease and Metabolic Health  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristiane A.","family":"Engebretsen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  Copenhagen 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Piti\u00e9\u2010Salp\u00eatri\u00e8re, INSERM UMRS 1138 CRC  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2023.06.003"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-019-00960-3"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/HEP.0000000000000004"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(22)00165-0"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms242015473"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s42255-021-00501-9"},{"key":"e_1_2_11_8_1","unstructured":"US Food and Drug Administration \u201cFDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease 2024 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