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Rosuvastatin for Primary Sclerosing Cholangitis (PSC)

This study is investigating if rosuvastatin, a common cholesterol medication, can help people with Primary Sclerosing Cholangitis (PSC), a liver disease with no current cure. Researchers want to understand how rosuvastatin affects bile acids (substances made by the liver) and the gut microbiome (the bacteria in your intestines) in PSC patients. You may be able to join if you are 18 to 80 years old and have a confirmed diagnosis of PSC, often along with inflammatory bowel disease (IBD). The main goal is to see changes in your bile acid profile after 12 weeks of taking rosuvastatin. This study hopes to provide important insights that could lead to new treatments for PSC. The study plans to enroll 15 participants, but its current status is unclear.

Study design
This is an interventional study where all 15 participants will receive rosuvastatin 20 mg once daily. There is no placebo group in this study.
What's involved
You will have baseline measurements, take rosuvastatin for a period, and then have follow-up after treatment. Specific details about visits or procedures are not provided.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up after completing statin treatment. Bile acid changes will be measured at baseline and week 12.

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NCT05912387

Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

Recruiting
EARLY_PHASE1Ages 18–80InterventionalBasic science
Stanford University
~15 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Rosuvastatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in bile acid (BA) profile: total bile acid
Measured over Baseline and week 12
+4 more outcomes measured

Conditions

Primary Sclerosing Cholangitis
Inflammatory Bowel Diseases

Explore related trials

Inflammatory Bowel DiseasePrimary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sidhartha Sinha, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Touran Fardeen
[email protected]
(650) 725-5890
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in bile acid (BA) profile: total bile acidBaseline and week 12

    BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.

  • Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratioBaseline and week 12

    BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.

  • Change in bile acid (BA) profile: conjugated:unconjugated BAs ratioBaseline and week 12

    BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.

  • Change in pathogen density in the small intestineBaseline and week 12

    Measure impact of statin therapy upon pathogen density (ratio of good bacteria to pathogenic bacteria) within the microbial community of the duodenum.

  • Change in bacterial gene expression profile in the small intestineBaseline and week 12

    This outcome aims to develop an understanding of the profile of microbial metabolic pathways in the duodenum and changes to the profile in response to statin therapy; gene sequencing with be done using shotgun metagenomics followed by pathway analysis.