A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)

June 1, 2026 updated by: Aldeyra Therapeutics, Inc.

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34209
        • Synergry Healthcare
      • Tampa, Florida, United States, 33606
        • Florida Health Sciences Center/Tampa General Hospital/USF
    • Texas
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Houston, Texas, United States, 77057
        • UDL Clinical Research, LLC
      • San Antonio, Texas, United States, 78229
        • Methodist Specialty and Transplant Hospital
    • Virginia
      • Richmond, Virginia, United States, 23221
        • Bon Secours Liver Institute of Newport News

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADX-629 (125 mg twice daily)
Drug: ADX-629
125 mg twice daily for 28 days
Drug: ADX-629
250 mg twice daily for 28 days
Experimental: ADX-629 (250 mg twice daily)
Drug: ADX-629
125 mg twice daily for 28 days
Drug: ADX-629
250 mg twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Event Query
Time Frame: Day 1 to Day 28
Incidence and severity of treatment-emergent adverse events
Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aldeyra Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-629-ALH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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