Could a common cholesterol drug unlock secrets of a rare liver disease?
NCT ID NCT05912387
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study at Stanford University is testing whether the statin drug rosuvastatin changes bile acid levels and gut bacteria in people with primary sclerosing cholangitis (PSC), a liver disease with no cure. Researchers will enroll 15 adults with PSC and inflammatory bowel disease, giving them a daily 20 mg statin pill. The goal is to understand the disease better, not to treat it directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rosuvastatin (a statin drug, 20 mg tablet once daily)
- What this could lead to
- If successful, this study could reveal how statins change bile acids and gut bacteria in PSC, pointing toward new treatment approaches for this liver disease.
- What could go wrong
- This is a very small, early-phase pilot study with only 15 participants. It is designed to gather information, not to test a treatment, so results may not lead to any direct benefit for patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and females, greater than or equal to 18 years of age * Established diagnosis of PSC, defined by either appropriate cholangiographic findings or supportive liver biopsy plus an established diagnosis of inflammatory bowel disease (IBD - Crohn's disease or ulcerative colitis) per American College of Gastroenterology (ACG) guidelines for the PSC-IBD arm * Hypercholesterolemia with BMI \< 25.0 for the comparison arm Exclusion Criteria: * Diagnosis of PSC-autoimmune hepatitis overlap syndrome * Woman who are pregnant, nursing, or expect to be pregnant * The presence of any comorbidity known to cause secondary sclerosing cholangitis, including: immunoglobulin G-4 (IgG4), associated cholangitis, recurrent bacterial cholangitis, recurrent pyogenic cholangitis, ischemic cholangiopathy, surgical biliary trauma, cholangiocarcinoma, and portal hypertensive biliopathy * Diagnosis of a serious medical condition (unless approved in writing by a physician) * Patients taking statin therapy prior to study initiation * Patients with known clinically allergy to statin therapy * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal * Bilirubin greater than 3.0 mg/dL * Recent use of antibiotics (within the last 90 days) * Concurrent use of any immunosuppressive medications (such as any calcineurin inhibitor, steroids at a dose greater than 10 mg of prednisone-equivalents per day) * Actively using a fibrate drug * Actively using a ritonavir containing drug * Familial hypercholesterolemia or other inherited disorder of lipid metabolism * Recent myocardial infarction or cerebrovascular accident * Body mass index \> 25.0 for the comparison arm * Chronic kidney disease stage 5 or end-stage renal disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGStanford, California, 94305, United States
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