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Can a malaria drug tame fatty liver? new trial aims to find out

NCT ID NCT07265297

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 3 trial tests whether hydroxychloroquine, a drug used for malaria and autoimmune diseases, can improve nonalcoholic steatohepatitis (NASH), a type of fatty liver with inflammation. 210 adults with confirmed fatty liver and elevated liver enzymes will take either 200 mg, 400 mg of HCQ, or a placebo daily for one year. The main goal is to see if HCQ lowers liver inflammation markers.

What this could mean

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

Active substance
hydroxychloroquine
What this could lead to
If it works, this could provide a new treatment option for nonalcoholic steatohepatitis, a common liver condition with no approved therapies.
What could go wrong
This is a Phase 3 trial, but hydroxychloroquine has known side effects like eye damage and heart rhythm issues. The study is relatively small (210 people) and may not show clear benefit over placebo.

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

About 210 people

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

Started

Aug 2025

Expected to finish

Dec 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 years and older

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: 1. Participants must be at least 18 years old. 2. Participants must be able to return for scheduled follow-up visits during specific time points within the 12-month study period. 3. Diagnosis of fatty liver confirmed by abdominal ultrasound or magnetic resonance imaging (MRI). 4. Evidence of hepatic inflammation for more than three months, indicated by alanine aminotransferase (ALT) \> 41 IU/L. Exclusion Criteria: 1. Participants younger than 18 years old. 2. Pregnant or breastfeeding women. 3. Active viral hepatitis, determined by serum HBV or HCV viral load. 4. Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications. 5. Known history of hypersensitivity or severe adverse drug reaction to HCQ. 6. Presence of retinal maculopathy.

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Steatohepatitis, nonalcoholic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan, Taiwan

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