{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T05:21:11Z","timestamp":1790659271450,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Saroglitazar magnesium, a dual PPAR \u03b1\/\u03b3 agonist, is approved in India for the treatment of non\u2010alcoholic fatty liver disease (NAFLD), now known as metabolic dysfunction\u2010associated steatotic liver disease (MASLD). While controlled trials with saroglitazar have demonstrated improvements in hepatic and metabolic parameters in patients with MASLD, real\u2010world data in populations with diverse metabolic comorbidities remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This is an ongoing, prospective, single\u2010arm, multicenter, real\u2010world, phase 4 study evaluating the effectiveness and safety of saroglitazar 4\u2009mg once daily in patients with MASLD. The current interim analysis includes 500 patients who completed 24\u2009weeks of treatment. Changes in liver stiffness measurement (LSM), hepatic steatosis (CAP and UAP), glycemic control, lipid profile, liver enzymes and non\u2010invasive fibrosis scores were assessed. Safety was evaluated based on treatment\u2010emergent adverse events (TEAEs). This was a non\u2010protocol\u2010defined, exploratory interim analysis; all statistical inferences are descriptive and\n                      <jats:italic>p<\/jats:italic>\n                      \u2010values are nominal.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At baseline, the mean age was 45.7\u2009\u00b1\u200911.6\u2009years, weight 81.0\u2009\u00b1\u200913.6\u2009kg, body mass index (BMI) 29.9\u2009\u00b1\u20094.7\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      and 42% had obesity. After 24\u2009weeks of treatment, mean LSM\u2009\u00b1\u2009SD decreased from 10.1\u2009\u00b1\u20093.2\u2009kPa to 8.0\u2009\u00b1\u20093.2\u2009kPa (\u221220.7%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) and CAP decreased by 20.3\u2009dB\/m (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). ALT levels reduced by 33.6% (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) and HbA1c by 4.8% (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Improvements were also observed in lipid profile and fibrosis scores (FIB\u20104, FAST, APRI, ALERT). A total of 68 patients (13.6%) reported TEAEs, the majority of which were mild (85.5%) and unrelated to the study drug. No deaths were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this interim real\u2010world analysis, saroglitazar 4\u2009mg was associated with improvements in liver stiffness, hepatic steatosis, metabolic parameters and non\u2010invasive fibrosis markers in patients with MASLD. The treatment was generally well tolerated. These findings warrant further confirmation upon completion of the 52\u2010week analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Impact and Implications<\/jats:title>\n                    <jats:p>Saroglitazar 4\u2009mg for 24\u2009weeks was associated with improvements in surrogate markers of liver injury, steatosis, glycaemic control and lipid metabolism, with good tolerability. These interim real\u2010world findings support further evaluation in the planned 52\u2010week analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Number<\/jats:title>\n                    <jats:p>CTRI\/2023\/05\/053326 [Registered on: 31\/05\/2023].<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/liv.70558","type":"journal-article","created":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T11:52:14Z","timestamp":1772970734000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Saroglitazar 4\u2009Mg in Metabolic Dysfunction\u2010Associated Steatotic Liver Disease: 24\u2010Week Results From Phase 4 Study"],"prefix":"10.1111","volume":"46","author":[{"given":"Arun","family":"Sanyal","sequence":"first","affiliation":[{"name":"School of Medicine Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soham","family":"Doshi","sequence":"additional","affiliation":[{"name":"Shree Siddhivinayak Maternity and Nursing Home  Nashik Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nitin","family":"Behl","sequence":"additional","affiliation":[{"name":"Neurociti Hospital  Ludhiana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hemant Kumar","family":"Gupta","sequence":"additional","affiliation":[{"name":"Samvedna Hospital  Varanasi Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Maharaja Agrasen Hospital  New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Kavitha","sequence":"additional","affiliation":[{"name":"Government General Hospital, GMC\/GGH Guntur Department of Gastroenterology  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mukesh","family":"Kalla","sequence":"additional","affiliation":[{"name":"SR Kalla Memorial Gastro and General Hospital  Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3106-6566","authenticated-orcid":false,"given":"Chirag","family":"Shah","sequence":"additional","affiliation":[{"name":"Mission Gastro Hospital  Ahmedabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakhi","family":"Maiwall","sequence":"additional","affiliation":[{"name":"Institute of Liver and Biliary Sciences  New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daksh","family":"Khurrana","sequence":"additional","affiliation":[{"name":"Alchemist Hospital Rd, Sector 21, Budanpur  Panchkula India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parshottam","family":"Koradia","sequence":"additional","affiliation":[{"name":"BAPS Pramukh Swami Hospital  Surat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhargav","family":"Darji","sequence":"additional","affiliation":[{"name":"Clinical Research and Development, Zydus Research Center, Zydus Lifesciences Ltd.  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevinkumar","family":"Kansagra","sequence":"additional","affiliation":[{"name":"Clinical Research and Development, Zydus Research Center, Zydus Lifesciences Ltd.  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deven","family":"Parmar","sequence":"additional","affiliation":[{"name":"Clinical Research and Development, Zydus Research Center, Zydus Lifesciences Ltd.  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,26]]},"reference":[{"issue":"3","key":"e_1_2_10_2_1","first-page":"663","article-title":"A Global Definition for Metabolic Dysfunction\u2010Associated Steatotic Liver Disease: An International Expert Consensus Statement","volume":"78","author":"Rinella M. 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