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Could a cholesterol drug help fight a rare liver disease?

NCT ID NCT06174402

Disease control Sponsor: Han Ying 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether adding fenofibrate (a drug used for high cholesterol) to standard treatment with ursodeoxycholic acid can improve liver health in people with primary biliary cholangitis (PBC), a rare autoimmune liver disease. About 184 adults with PBC will receive either fenofibrate or a placebo, plus their usual medication, for up to 48 weeks. The main goal is to see if the combo helps normalize a key liver enzyme (alkaline phosphatase) and reduces itching.

What this could mean

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

Active substance
Fenofibrate (a drug to lower fats in the blood) and ursodeoxycholic acid (a bile acid drug)
What this could lead to
If it works, this combination could offer a better way to control primary biliary cholangitis, potentially slowing liver damage and easing symptoms like itching.
What could go wrong
This is a mid-stage trial with 184 people, so results may not apply to everyone. Fenofibrate can cause side effects like muscle pain or liver issues, and the added benefit over standard care is uncertain.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 184 people

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

Started

Aug 2023

Expected to finish

Dec 2026

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 * Male or female with a diagnosis of PBC, by at least two of the following criteria: 1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months; 2. Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies; 3. Documented liver biopsy result consistent with PBC. * Incomplete response to UDCA defined by 1 ULN\< ALP \<= 1.67 ULN * Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0 Exclusion Criteria: * History or presence of other concomitant liver diseases. * ALT or AST \> 5×ULN, total bilirubin（TBIL） \> 3×ULN. * If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * Allergic to fenofibrate or ursodeoxycholic acid. * Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. * Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min. * Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * Planned to receive an organ transplant or an organ transplant recipient. * Needing Liver transplantation within 1 year according to the Mayo Rick score. * Any other condition(s) that would compromise the safety of the subject or compromise

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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

Contacts and locations

Locations

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Nanjing Second Hospital

    Nanjing, Jiangsu, China

  • Peking Union Medical College Hospital

    Beijing, China

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, China

  • The First Hospital of China Medical University

    Shenyang, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The second hospital of Lanzhou University

    Lanzhou, Gansu, China

  • Tianjin Third Central Hospital

    Tianjin, China

  • Xijing Hospital

    Xi'an, Shaanxi, China

  • Yan'an University Affiliated Hospital

    Yan’an, Shanxxi, China

More trials for these conditions

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