Plain-English translation of NCT07282353 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Primary Biliary Cholangitis research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing a new medication called CS0159 to help people with primary biliary cholangitis (a disease where the body's immune system damages bile ducts in the liver) who either aren't getting better with their current standard treatment or can't tolerate it. About 135 people will participate: some will take CS0159 daily, and others will take a placebo (a pill with no active ingredient). The study will last up to 52 weeks and measure whether this medication helps improve liver function.
Primary biliary cholangitis is a serious liver condition, and the standard treatment doesn't work well for everyone—some patients don't improve enough, and others experience side effects they can't tolerate. This medication is being tested as a potential new option for those patients who need additional help.
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Participants will visit the study clinic regularly over 52 weeks (about one year) for blood work and health check-ups to monitor how well the medication is working and watch for any side effects. You'll take either the new medication or a placebo once daily at home. If you were already taking your standard treatment before joining, you may continue it during the study. The study team will track your liver function and overall health throughout the trial.
AI-generated summary from trial data · Jun 21, 2026 · Not medical advice
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