A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ALS-L1023 in Non-Alcoholic Fatty Liver Diseaseopen access
- Authors
- Kim, Gi-Ae; Cho, Hyun Chin; Jeong, Soung Won; Kang, Bo-Kyeong; Kim, Mimi; Jung, Seungwon; Hwang, Jungwook; Yoon, Eileen L.; Jun, Dae Won
- Issue Date
- Apr-2023
- Publisher
- MDPI
- Keywords
- ALS-L1023; non-alcoholic fatty liver disease; non-alcoholic steatohepatitis
- Citation
- PHARMACEUTICALS, v.16, no.4, pp.1 - 12
- Indexed
- SCIE
SCOPUS
- Journal Title
- PHARMACEUTICALS
- Volume
- 16
- Number
- 4
- Start Page
- 1
- End Page
- 12
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/185875
- DOI
- 10.3390/ph16040623
- ISSN
- 1424-8247
- 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.
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