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Can a common cholesterol drug help manage a rare liver disease?

NCT ID NCT07104201

Disease control Sponsor: Xijing Hospital of Digestive Diseases 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial is testing the long-term safety of fenofibrate, a drug usually used for high cholesterol, in people with primary biliary cholangitis (PBC), a rare liver disease. The study involves 15 adults who have already completed a previous fenofibrate trial for PBC. Researchers are monitoring side effects and changes in liver function to see if the drug remains safe over an extended period.

What this could mean

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

Active substance
a drug called fenofibrate, typically used to lower fats in the blood
What this could lead to
If fenofibrate proves safe over the long term, it could become an additional treatment option for managing PBC.
What could go wrong
This is a very early, small study with only 15 participants, so results may not apply to everyone. Side effects from fenofibrate are possible.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2035

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: * Must have provided written informed consent * Age 18-75 years; * BMI 17-28 kg/m2 * Completed in a PBC study with fenofibrate(NCT06591455) Exclusion Criteria: * Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.; * Transaminases \>5 x ULN or total bilirubin \>3 x ULN; * Pregnant or breastfeeding women, or women planning to conceive during the study period; * Allergy to fenofibrate or ursodeoxycholic acid; * Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use; * Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously; * History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse); * Creatinine \>1.5 x ULN and creatinine clearance \<60 mL/min; * Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen); * Planned organ transplantation or previous organ transplantation; * Need for liver transplantation within 1 year according to the Mayo risk score; * Any other condition considered unsuitable for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

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

Primary biliary cholangitis (PBC)

Contacts and locations

Locations

  • Xijing Hospital

    Xi'an, Shaanxi, 710032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.