Alcohol HepatitisPhase 2NCT06685692
A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
A Phase 2 study testing ADX-629 in people with Alcohol Hepatitis, run by Aldeyra Therapeutics, Inc. at 6 sites in United States.
Trial summary
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Hepatitis
- What is being tested?
- ADX-629
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Nov 2024to 18 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Synergry Healthcare
Bradenton, Florida, 34209
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
UDL Clinical Research, LLC
Houston, Texas, 77057
Bon Secours Liver Institute of Newport News
Richmond, Virginia, 23221
Methodist Specialty and Transplant Hospital
San Antonio, Texas, 78229
Florida Health Sciences Center/Tampa General Hospital/USF
Tampa, Florida, 33606
About this study
Official title: 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)
- Conditions
- Alcohol Hepatitis
- Being tested
- ADX-629
- Keywords
- ADX-629
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-629Drug
125 mg twice daily for 28 days
ADX-629Drug
250 mg twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ADX-629 (125 mg twice daily) | Experimental | Not described Receives: Drug: ADX-629 |
| ADX-629 (250 mg twice daily) | Experimental | Not described Receives: Drug: ADX-629 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Event Query
Incidence and severity of treatment-emergent adverse events
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start4 Nov 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685692
- Sponsor's protocol ID
- ADX-629-ALH-001
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis
- ClinicalTrials.gov ID
- NCT06685692
- Acronym / sponsor ID
- ADX-629-ALH-001
- Conditions
- Alcohol Hepatitis
- Keywords
- ADX-629
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-629 (125 mg twice daily) | Experimental | Drug: ADX-629 |
| ADX-629 (250 mg twice daily) | Experimental | Drug: ADX-629 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-629125 mg twice daily for 28 days | Drug | ADX-629 (125 mg twice daily) |
| ADX-629250 mg twice daily for 28 days | Drug | ADX-629 (250 mg twice daily) |
Primary outcome
Treatment-Emergent Adverse Event Query
Time frame: Day 1 to Day 28
Incidence and severity of treatment-emergent adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-629 in people with Alcohol Hepatitis, run by Aldeyra Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Event Query (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.