{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T06:05:23Z","timestamp":1792130723908,"version":"4.4.0"},"reference-count":31,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2020,7,14]],"date-time":"2020-07-14T00:00:00Z","timestamp":1594684800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T00:00:00Z","timestamp":1593561600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>We evaluated the safety and efficacy of cilofexor (formerly GS\u20109674), a small\u2010molecule nonsteroidal agonist of farnesoid X receptor, in patients with nonalcoholic steatohepatitis (NASH).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Approach and Results<\/jats:title>\n            <jats:p>In this double\u2010blind, placebo\u2010controlled, phase 2 trial, 140 patients with noncirrhotic NASH, diagnosed by magnetic resonance imaging\u2013proton density fat fraction (MRI\u2010PDFF) \u22658% and liver stiffness \u22652.5\u00a0kPa by magnetic resonance elastography (MRE) or historical liver biopsy, were randomized to receive cilofexor 100\u00a0mg (n\u00a0=\u00a056), 30\u00a0mg (n\u00a0=\u00a056), or placebo (n\u00a0=\u00a028) orally once daily for 24\u00a0weeks. MRI\u2010PDFF, liver stiffness by MRE and transient elastography, and serum markers of fibrosis were measured at baseline and week 24. At baseline, median MRI\u2010PDFF was 16.3% and MRE\u2010stiffness was 3.27\u00a0kPa. At week 24, patients receiving cilofexor 100\u00a0mg had a median relative decrease in MRI\u2010PDFF of \u221222.7%, compared with an increase of 1.9% in those receiving placebo (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.003); the 30\u2010mg group had a relative decrease of \u22121.8% (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.17 vs. placebo). Declines in MRI\u2010PDFF of \u226530% were experienced by 39% of patients receiving cilofexor 100\u00a0mg (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.011 vs. placebo), 14% of those receiving cilofexor 30\u00a0mg (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.87 vs. placebo), and 13% of those receiving placebo. Serum gamma\u2010glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in Enhanced Liver Fibrosis scores and liver stiffness were not observed. Cilofexor was generally well\u2010tolerated. Moderate to severe pruritus was more common in patients receiving cilofexor 100\u00a0mg (14%) than in those receiving cilofexor 30\u00a0mg (4%) and placebo (4%).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Cilofexor for 24\u00a0weeks was well\u2010tolerated and provided significant reductions in hepatic steatosis, liver biochemistry, and serum bile acids in patients with NASH. ClinicalTrials.gov No. NCT02854605.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.31205","type":"journal-article","created":{"date-parts":[[2020,3,2]],"date-time":"2020-03-02T07:26:54Z","timestamp":1583134014000},"page":"58-71","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":335,"title":["Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial"],"prefix":"10.1097","volume":"72","author":[{"given":"Keyur","family":"Patel","sequence":"first","affiliation":[{"name":"University of Toronto,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Harrison","sequence":"additional","affiliation":[{"name":"Pinnacle Clinical Research,San Antonio,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdy","family":"Elkhashab","sequence":"additional","affiliation":[{"name":"Toronto Liver Center,Toronto,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James F.","family":"Trotter","sequence":"additional","affiliation":[{"name":"Texas Digestive Disease Consultants,Dallas,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Herring","sequence":"additional","affiliation":[{"name":"Quality Medical Research,Nashville,TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio E.","family":"Rojter","sequence":"additional","affiliation":[{"name":"Ruane Clinical Research,Los Angeles,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zeid","family":"Kayali","sequence":"additional","affiliation":[{"name":"Inland Empire Liver Foundation,Rialto,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2215-9410","authenticated-orcid":false,"given":"Vincent Wai\u2010Sun","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Medicine and Therapeutics,The Chinese University of Hong Kong,Hong Kong,Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Greenbloom","sequence":"additional","affiliation":[{"name":"Toronto Digestive Disease Associates,Woodbridge,ON,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saumya","family":"Jayakumar","sequence":"additional","affiliation":[{"name":"University of California San Diego,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell L.","family":"Shiffman","sequence":"additional","affiliation":[{"name":"Bon Secours Mercy Health,Richmond,VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Freilich","sequence":"additional","affiliation":[{"name":"Kansas City Research Institute,Kansas City,MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric J.","family":"Lawitz","sequence":"additional","affiliation":[{"name":"Texas Liver Institute,University of Texas Health San Antonio,San Antonio,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward J.","family":"Gane","sequence":"additional","affiliation":[{"name":"Liver Unit,Auckland City Hospital,Auckland,New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eliza","family":"Harting","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Xu","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew N.","family":"Billin","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuhan","family":"Chung","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Stephen","family":"Djedjos","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. Mani","family":"Subramanian","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P.","family":"Myers","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.,Foster City,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S.","family":"Middleton","sequence":"additional","affiliation":[{"name":"University of California San Diego,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Rinella","sequence":"additional","affiliation":[{"name":"Feinberg School of Medicine,Northwestern University,Chicago,IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mazen","family":"Noureddin","sequence":"additional","affiliation":[{"name":"Cedars\u2010Sinai Medical Center,Los 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