Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease

Summary

This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.

Timeline

Start

2023-02-06

Primary completion

2024-03-29

Completion

2024-03-29

Outcome

Met primary endpoint

paper greater reduction in serum ALT levels from baseline in the UDCA-treated patients than in the placebo group (-14.70 vs. -5.51 U/L; P = 0.010). PMID 42153228 ↗

Publications

• Chang Y, Cho YK, Kim YS, Kim SE, Cheon GJ, Kim JH, Yang H, Kim W, Ahn SB, Yoon EL, Cheong JY, Lee JW, Kim MY, Kim HJ, Lee SH, Cho EY, Choi NR, Lee HW, Kim KM, Choe WH, Yu JM, Kim SY, Jang JY. Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Korean Med Sci. 2026 May 18;41(19):e89. doi: 10.3346/jkms.2026.41.e89.

Drugs

Indications