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New drug shows promise for alcohol hepatitis in early trial

NCT ID NCT06685692

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental drug called ADX-629 in 4 adults with moderate alcohol-related hepatitis. The goal was to see if the drug is safe and can help control liver inflammation. Participants had to stop drinking alcohol during the trial. The study is now complete, and results will show whether the drug is worth testing in larger trials.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 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: * Adult ≥ 21 years old on the day of signing the informed consent form; * Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening * Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment * Ability and willingness to swallow tablets * Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements Exclusion Criteria: * Pregnant, intending to become pregnant (or father a child), or breastfeeding * Current or recent enrollment in another interventional trial in the 30 days prior to screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Bon Secours Liver Institute of Newport News

    Richmond, Virginia, 23221, United States

  • Florida Health Sciences Center/Tampa General Hospital/USF

    Tampa, Florida, 33606, United States

  • Methodist Specialty and Transplant Hospital

    San Antonio, Texas, 78229, United States

  • Synergry Healthcare

    Bradenton, Florida, 34209, United States

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • UDL Clinical Research, LLC

    Houston, Texas, 77057, United States