Standard-dose ursodeoxycholic acid improves biochemical liver function and fibrosis in chronic liver disease: multicenter, randomized, double-blind, placebo-controlled trial. 

<h2 id="Introduction">Introduction</h2><ul><li>Chronic liver disease (CLD), caused by conditions such as viral hepatitis, alcohol-related liver disease, and metabolic dysfunction-associated steatotic liver disease (MASLD), may progress to fibrosis, cirrhosis, and serious liver-related complications. However, effective and accessible pharmacological options remain limited for many patients.</li><li>Ursodeoxycholic acid (UDCA) is a naturally occurring hydrophilic bile acid with hepatoprotective, anti-apoptotic, and cell membrane-stabilizing properties. Although previous studies have reported inconsistent results across different doses and treatment durations, UDCA is commonly prescribed in clinical practice. Therefore, this study evaluated the efficacy and safety of UDCA in patients with CLD.</li></ul><h2 id="Study Design">Study Design</h2><img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867383956-e2aa788f71d5-Screenshot_2026-10-13_101947.webp" alt="Study Design" width="1452" height="343"><h2 id="Assessments">Assessments</h2><ul><li>ALT, AST, and GGT were assessed using central laboratory testing.</li><li>Liver fibrosis was assessed using VCTE and FibroTest at baseline and Week 8.</li><li>Fatigue was assessed using the K-CFQ at baseline, Week 4, and Week 8.</li><li>Mean treatment adherence exceeded 90% in both groups.</li></ul><h2 id="Results">Results</h2>Changes in ALT from baseline at Week 8<ul><li>At Week 8, UDCA produced a significantly greater reduction in ALT than placebo (−14.70 vs −5.51 U/L; Fig. 1).</li></ul>Figure 1. Change in ALT Levels from Baseline to Week 8<img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867460665-53999b0e2ca8-Screenshot_2026-10-13_102051.webp" alt="Change in ALT Levels from Baseline to Week 8" width="947" height="458">Changes in ALT at Week 4<ul><li>At Week 4, ALT decreased by −13.18 U/L with UDCA versus −1.87 U/L with placebo (Fig. 2).</li></ul>Figure 2: Effect of UDCA on ALT Reduction at Week 4 &nbsp;<img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867514341-f346e6713f8f-Screenshot_2026-10-13_102132.webp" alt="Effect of UDCA on ALT Reduction at Week 4" width="509" height="453">Changes in ALT, GGT and AST from baseline at Week 4 and Week 8<ul><li>UDCA significantly reduced GGT levels at Weeks 4 and 8, while AST reductions were numerically greater with UDCA than placebo (Fig. 3).</li><li>UDCA also significantly increased ALT normalization at Week 4 and 8, with results consistent between the FAS and PPS analyses.</li></ul>Figure 3: Effect of UDCA on ALT, GGT and AST levels<img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867583424-8da0c45ece7b-Screenshot_2026-10-13_102233.webp" alt="Effect of UDCA on ALT, GGT and AST levels" width="1461" height="401">Liver fibrosis assessed using VCTE and FibroTest at Week 8<ul><li>At Week 8, UDCA significantly improved FibroTest scores, while VCTE showed a favorable but non-significant reduction in liver stiffness compared with placebo (Fig. 4).</li></ul>Figure 4: Effect of UDCA on Liver fibrosis at Week 8<img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867668379-4b42e54abc16-Screenshot_2026-10-13_102359.webp" alt="Effect of UDCA on Liver fibrosis at Week 8" width="990" height="430">Safety Profile of UDCA Compared with Placebo<ul><li>UDCA was well tolerated, with no serious adverse events or deaths and an overall safety profile comparable to placebo (Fig. 5).</li></ul>Figure 5: UDCA Demonstrated a Favorable Safety Profile<img src="https://cdn.megawecare.com/GHBY/Internal-Images/1791867738816-f1362c608927-Screenshot_2026-10-13_102446.webp" alt="UDCA Demonstrated a Favorable Safety Profile" width="982" height="422"><h2 id="Conclusions" data-section="conclusion">Conclusions</h2><ul><li>In patients with chronic liver disease, UDCA three times daily for 8 weeks significantly improved liver biochemical markers, including ALT and GGT, and increased ALT normalization compared with placebo.</li><li>UDCA also showed favorable effects on non-invasive fibrosis markers and was well tolerated.</li><li>Longer-term studies are needed to determine the durability of these effects and their impact on fibrosis regression. &nbsp;</li></ul>Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CLD, chronic liver disease; FAS, full analysis set; GGT, gamma-glutamyl transferase; K-CFQ, Korean-Chronic Fatigue Questionnaire; MASLD, metabolic dysfunction-associated steatotic liver disease; OR, odds ratio; PPS, per-protocol set; UDCA, ursodeoxycholic acid; VCTE, vibration-controlled transient elastography.Disclaimer: This scientific information content is facilitated by Mega Lifesciences and is intended for healthcare professionals for their reading and update. Although care has been taken in compiling and checking the information, the facilitator is not responsible, or in any way liable for any errors, omissions or inaccuracies in this content whether arising from negligence or otherwise, however, or for any consequences arising therefrom.

3896dc68eef2 GASTRO UPDATES 2026   ISSUE   5

<ol dir="ltr"><li><a href="#Introduction">Introduction</a></li><li><a href="#Study Design">Study Design</a></li><li><a href="Assessments">Assessments</a></li><li><a href="#Results">Results</a></li><li><a href="#Conclusions">Conclusions</a></li></ol>

Standard-dose ursodeoxycholic acid improves biochemical liver function and fibrosis in chronic liver disease: multicenter, randomized, double-blind, placebo-controlled trial.

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