A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ALS-L1023 in Non-Alcoholic Fatty Liver Disease
DC Field | Value | Language |
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dc.contributor.author | Kim, Gi-Ae | - |
dc.contributor.author | Cho, Hyun Chin | - |
dc.contributor.author | Jeong, Soung Won | - |
dc.contributor.author | Kang, Bo-Kyeong | - |
dc.contributor.author | Kim, Mimi | - |
dc.contributor.author | Jung, Seungwon | - |
dc.contributor.author | Hwang, Jungwook | - |
dc.contributor.author | Yoon, Eileen L. | - |
dc.contributor.author | Jun, Dae Won | - |
dc.date.accessioned | 2023-06-01T07:06:11Z | - |
dc.date.available | 2023-06-01T07:06:11Z | - |
dc.date.created | 2023-05-16 | - |
dc.date.issued | 2023-04 | - |
dc.identifier.issn | 1424-8247 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/185875 | - |
dc.description.abstract | 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] >= 8% and liver fibrosis >= 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 (-15.0%, p = 0.03). There was a significant reduction in liver stiffness from baseline in the 1200 mg ALS-L1023 group (-10.7%, p = 0.03). Serum alanine aminotransferase decreased by -12.4% in the 1800 mg ALS-L1023 group, -29.8% in the 1200 mg ALS-L1023 group, and -4.9% 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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | MDPI | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kang, Bo-Kyeong | - |
dc.contributor.affiliatedAuthor | Kim, Mimi | - |
dc.contributor.affiliatedAuthor | Hwang, Jungwook | - |
dc.contributor.affiliatedAuthor | Jun, Dae Won | - |
dc.identifier.doi | 10.3390/ph16040623 | - |
dc.identifier.scopusid | 2-s2.0-85154582742 | - |
dc.identifier.wosid | 000977281300001 | - |
dc.identifier.bibliographicCitation | PHARMACEUTICALS, v.16, no.4, pp.1 - 12 | - |
dc.relation.isPartOf | PHARMACEUTICALS | - |
dc.citation.title | PHARMACEUTICALS | - |
dc.citation.volume | 16 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 12 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Chemistry, Medicinal | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | ASSOCIATION | - |
dc.subject.keywordPlus | MRI | - |
dc.subject.keywordAuthor | ALS-L1023 | - |
dc.subject.keywordAuthor | non-alcoholic fatty liver disease | - |
dc.subject.keywordAuthor | non-alcoholic steatohepatitis | - |
dc.identifier.url | https://www.mdpi.com/1424-8247/16/4/623 | - |
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