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Could a cholesterol drug and a bile acid pill help reverse liver scarring?

NCT ID NCT07102979

Disease control Sponsor: Chang Gung Memorial Hospital 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This pilot study tests whether simvastatin (a cholesterol-lowering drug) and ursodeoxycholic acid (a bile acid medication), taken alone or together for six months, can improve markers of liver fibrosis in adults with advanced liver scarring after viral hepatitis has been controlled. The study also examines changes in gut bacteria and immune markers. Because it is a small, exploratory trial with only 18 participants, the results are not definitive but may guide future research.

What this could mean

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

Active substance
simvastatin and ursodeoxycholic acid (UDCA), taken orally for 6 months
What this could lead to
If the combination works, it could point toward a new way to slow or reverse liver fibrosis using widely available drugs.
What could go wrong
This is a very small pilot study with only 18 participants, so results are exploratory and may not apply to broader populations. Neither drug is proven to reverse cirrhosis.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

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: * Adults aged 18 to 75 years * Diagnosed with advanced fibrosis; the cohort was operationally defined by a FibroScan liver stiffness measurement of ≥9.5 kPa. * Achieved sustained virological response (SVR) at least 6 months after hepatitis C treatment, or * Non-replicating hepatitis B infection (undetectable viral load) for at least 6 months * Able and willing to provide informed consent Exclusion Criteria: * Current or prior use of statins * Liver decompensation (jaundice, ascites, hepatic coma, or esophagogastric varices) * Diagnosed hepatocellular carcinoma or other liver cancers * Alcoholic liver disease or moderate-to-severe fatty liver * Diagnosed diabetes mellitus * Chronic kidney disease * Use of antibiotics within the past 3 months * Use of gastric ulcer medications such as proton pump inhibitors (PPIs) * Pregnancy or breastfeeding * Any condition deemed by the investigator to interfere with study participation or outcomes

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease hepatitis B virus infection hepatitis C virus infection

As listed by the trial registrant

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

Liver fibrosis

Contacts and locations

Locations

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Others, 833, Taiwan

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