Ursodeoxycholic acid reduces ALT and fibrosis in chronic liver disease patients

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Journal of Korean medical science Published May 19, 2026 Medically reviewed May 19, 2026 Study authors: Chang Young, Cho Yong Kyun, Kim Young Seok, Kim Sung-Eun, Cheon Gab Jin, Kim Ji Hoon, Yang Hyun, Kim… PubMed ↗ NCT06272630 ↗ DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider UDCA 100 mg three times daily for 8 weeks to reduce ALT and fibrosis in chronic liver disease with elevated ALT, though long-term data are lacking.

This multicenter, phase IV randomized controlled trial conducted in academic hospitals in South Korea enrolled 262 patients with chronic liver disease and abnormal serum ALT levels persisting for at least 6 months. Patients were randomized to receive ursodeoxycholic acid (UDCA) 100 mg three times daily or placebo for 8 weeks.

The primary outcome was mean relative change in ALT from baseline. UDCA showed a significantly greater reduction in ALT levels compared with placebo (-14.70 vs. -5.51 U/L, p = 0.010). ALT normalization rates were also higher in the UDCA group (26.52% vs. 13.08%; odds ratio 2.60, p = 0.005). Additionally, fibrosis reduction measured by FibroTest score was greater with UDCA (-0.03 vs. -0.00, p = 0.016).

Safety was comparable between groups, with no serious adverse events reported in the UDCA arm. The frequency of adverse events was similar, and no discontinuations were reported. The study suggests a favorable safety profile for UDCA over 8 weeks.

Key limitations include the short 8-week follow-up and the use of FibroTest rather than histology for fibrosis assessment. Longer-term studies are needed to confirm durability of effects and impact on clinical outcomes. Nonetheless, these results support UDCA as a treatment option for patients with chronic liver disease and persistently elevated ALT.

Study Details

Study typeRct

Sample sizen = 262

EvidenceLevel 2

Follow-up6.0 mo

PublishedMay 2026

PMID42153228

TrialNCT06272630

View Original Abstract ↓

BACKGROUND: This study evaluated the efficacy and safety of standard-dose ursodeoxycholic acid (UDCA; fixed daily dose of 300 mg/day) compared with placebo, in patients with chronic liver disease. METHODS: A multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial was conducted in academic hospitals in South Korea. Patients with chronic liver disease and abnormal serum alanine aminotransferase (ALT) levels in at least two consecutive results prior to screening, persisting for at least 6 months, were randomly assigned to receive 100 mg UDCA or placebo three times daily for 8 weeks. The primary endpoint was the mean relative change in ALT levels from baseline. The secondary endpoints included changes in fibrosis and drug-related adverse events. RESULTS: A total of 262 patients were analyzed (132 in the UDCA group and 130 in the placebo group). By week 8, there was a significantly 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; = 0.010). The ALT normalization rates were higher in the UDCA group (26.52% vs. 13.08%; odds ratio, 2.60; = 0.005). Fibrosis reduction, as assessed by the FibroTest score, was greater in the UDCA group (-0.03 vs. -0.00; = 0.016). The frequency of adverse events in the two groups was similar, with no serious adverse events reported in the UDCA group. CONCLUSION: In patients with chronic liver disease, 100 mg UDCA three times daily for 8 weeks improved ALT levels and fibrosis, and had a favorable safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06272630.