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Could a common cholesterol drug help fight a rare liver disease?

NCT ID NCT04133792

Disease control Sponsor: Annika Bergquist Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tests whether taking 40 mg of simvastatin daily for 5 years can improve outcomes for people with primary sclerosing cholangitis (PSC), a rare liver disease. About 560 patients will receive either simvastatin or a placebo. Researchers will track survival, need for liver transplant, bleeding, and cancer rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
simvastatin
What this could lead to
If it works, this could provide a simple, low-cost way to slow liver disease progression and reduce the need for transplants in PSC patients.
What could go wrong
This is a large Phase 3 trial, but simvastatin is already widely used for cholesterol—its benefit for PSC is unproven. The study may show no significant improvement in survival or complications.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

571 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD). * Men and women between ≥18 years and ≤75 years. * Written informed consent. * A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization. * Colonoscopy performed within 24 months prior to randomization, if known IBD. * For women of childbearing potential efficient contraceptive. Exclusion Criteria: * Subjects on waiting list for transplantation * Transplanted subjects * Previous variceal bleeding * Previous hepatobiliary malignancy * Subjects with secondary sclerosing cholangitis * Intake of any type of statins within 3 months prior to randmization * Known intolerance to simvastatin. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary sclerosing cholangitis

Contacts and locations

Locations

  • Akademiska sjukhuset

    Uppsala, 751 85, Sweden

  • Danderyds sjukhus

    Stockholm, 182 57, Sweden

  • Karlstads centralsjukhus

    Karlstad, 652 30, Sweden

  • Karolinska University Hospital

    Stockholm, 141 57, Sweden

  • Karolinska University Hospital Solna

    Stockholm, 171 64, Sweden

  • Norrlands Universitetssjukhus

    Umeå, Västerbotten County, 907 37, Sweden

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Sahlgrenska Universitetssjukhuset Östra

    Gothenburg, 41685, Sweden

  • Skaraborgs sjukhus

    Lidköping, Sweden

  • Skåne Universitetssjukhus

    Malmö, Skåne County, 222 42, Sweden

  • Universitetssjukhuset i Linköping

    Linköping, Östergötland County, 581 85, Sweden

  • Örebro Universitetssjukhus

    Örebro, 701 85, Sweden

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