{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:41:09Z","timestamp":1787499669589,"version":"build-2736575974"},"reference-count":20,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T00:00:00Z","timestamp":1681948800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AngioLab, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Preclinical data have shown that the herbal extract, ALS-L1023, from Melissa officinalis reduces visceral fat and hepatic steatosis. We aimed to assess the safety and efficacy of ALS-L1023 as the treatment of non-alcoholic fatty liver disease (NAFLD). We conducted a 24-week randomized, double-blind, placebo-controlled 2a study in patients with NAFLD (MRI-proton density fat fraction [MRI-PDFF] \u2265 8% and liver fibrosis \u2265 2.5 kPa on MR elastography [MRE]) in Korea. Patients were randomly assigned to 1800 mg ALS-L1023 (n = 19), 1200 mg ALS-L1023 (n = 21), or placebo (n = 17) groups. Efficacy endpoints included changes in liver fat on MRI-PDFF, liver stiffness on MRE, and liver enzymes. For the full analysis set, a relative hepatic fat reduction from baseline was significant in the 1800 mg ALS-L1023 group (\u221215.0%, p = 0.03). There was a significant reduction in liver stiffness from baseline in the 1200 mg ALS-L1023 group (\u221210.7%, p = 0.03). Serum alanine aminotransferase decreased by \u221212.4% in the 1800 mg ALS-L1023 group, \u221229.8% in the 1200 mg ALS-L1023 group, and \u22124.9% in the placebo group. ALS-L1023 was well tolerated and there were no differences in the incidence of adverse events among the study groups. ALS-L1023 could reduce hepatic fat content in patients with NAFLD.<\/jats:p>","DOI":"10.3390\/ph16040623","type":"journal-article","created":{"date-parts":[[2023,4,21]],"date-time":"2023-04-21T02:05:31Z","timestamp":1682042731000},"page":"623","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ALS-L1023 in Non-Alcoholic Fatty Liver Disease"],"prefix":"10.3390","volume":"16","author":[{"given":"Gi-Ae","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun Chin","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju 52727, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soung Won","family":"Jeong","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Seoul Hospital, Seoul 04401, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo-Kyeong","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Radiology, Hanyang University College of Medicine, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8266-0226","authenticated-orcid":false,"given":"Mimi","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Radiology, Hanyang University College of Medicine, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seungwon","family":"Jung","sequence":"additional","affiliation":[{"name":"Graduate School for Biomedical Science & Engineering, Hanyang University, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2290-1649","authenticated-orcid":false,"given":"Jungwook","family":"Hwang","sequence":"additional","affiliation":[{"name":"Graduate School for Biomedical Science & Engineering, Hanyang University, Seoul 04763, Republic of Korea"},{"name":"Hanyang Institute of Bioscience and Biotechnology, Hanyang University, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eileen L.","family":"Yoon","sequence":"additional","affiliation":[{"name":"Hanyang Institute of Bioscience and Biotechnology, Hanyang University, Seoul 04763, Republic of Korea"},{"name":"Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2875-6139","authenticated-orcid":false,"given":"Dae Won","family":"Jun","sequence":"additional","affiliation":[{"name":"Hanyang Institute of Bioscience and Biotechnology, Hanyang University, Seoul 04763, Republic of Korea"},{"name":"Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,4,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"739","DOI":"10.1016\/S2468-1253(20)30077-7","article-title":"Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: A systematic review and meta-analysis","volume":"5","author":"Ye","year":"2020","journal-title":"Lancet Gastroenterol. 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