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Experimental liver drug INT-787 studied for severe alcohol hepatitis

NCT ID NCT05639543

Disease control Sponsor: Intercept Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called INT-787 in 67 people with severe alcohol-associated hepatitis, a serious liver condition. The trial was a phase 2a proof-of-concept study, but it was terminated early. Researchers were looking at safety, how well the drug works, and how the body processes it.

What this could mean

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

Active substance
INT-787
What this could lead to
If successful, INT-787 could offer a new treatment option for severe alcohol-associated hepatitis, potentially improving liver function and survival.
What could go wrong
This was an early-phase trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

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

67 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

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

18 to 65 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: 1. Males or females aged 18 to 65 years (inclusive) 2. Clinical diagnosis of sAH based on all the following: 1. History of ongoing excess alcohol (\>60 g/day \[male\] or \>40 g/day \[female\]) use for ≥6 months, with \<60 days of abstinence prior to the onset of jaundice 2. Serum total bilirubin \>3.0 mg/dL 3. Aspartate aminotransferase (AST) ≥50 U/L 4. AST/Aspartate aminotransferase (ALT) ratio ≥1.5 5. Onset of jaundice within prior 8 weeks 6. Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70 7. Cohort 5 and Cohort 6: mDF ≥32 3. Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30 4. Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows: * Surgical sterilization (bilateral tubal occlusion, etc.) * Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system \[IUS\]) * Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation: * Oral * Intravaginal * Transdermal * Progesterone-only hormonal contraception associated with inhibition of ovulation: * Oral * Injectable * Implantable * Sexual abstinence: When in line with the preferred and usual lifestyle of the participant, is defined as avoiding all types of activity that could result in conception (pregnancy) from the initiation of Screening and until at least 90 days after the last dose of investigational product Exclusion Criteria: 1. Participants taking products containing obeticholic acid in the 30 days prior to randomization 2. Participants taking \>2 doses of systemic corticosteroids within 30 days prior to randomization. 3. Participants who have been inpatient at a referral hospital for \>7 days prior to transfer. 4. Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding. 5. Abstinence from alcohol consumption for \>2 months before Day 1. 6. AST or ALT \>400 U/L. 7. Cohort 1 through Cohort 4: mDF \<32 or \>70. 8. Cohort 5 and Cohort 6: mDF \<32 9. Cohort 1 through Cohort 4: MELD score \<18 or \>25. 10. Cohort 5 and Cohort 6: MELD \<21 or \>30 11. Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen \[HBsAg\] positive), chronic hepatitis C virus (HCV) RNA positive, drug-induced liver injury (DILI), biliary obstruction, and autoimmune liver disease. 12. Current or previous history of hepatocellular carcinoma (HCC) 13. History of liver transplantation or currently listed for liver transplant Note: Additional protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis hepatitis

As listed by the trial registrant

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

Alcohol-associated hepatitis

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU Angers

    Angers, 49933, France

  • Cambridge University NHS Foundation Trust

    Cambridge, United Kingdom

  • Clinical Translational Research Site

    Miami, Florida, 33136, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hopital Beaujon

    Clichy, 92118, France

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Pitie Salpetriere

    Paris, 75013, France

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Imperial College Healthcare NHS Trust

    London, United Kingdom

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Northwell Health Center for Liver Disease and Transplantation

    Manhasset, New York, 11030, United States

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford Healthcare

    Palo Alto, California, 94305, United States

  • Tampa General Medical Group

    Tampa, Florida, 33606, United States

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • University Hospitals Plymouth NHS Trust

    Plymouth, United Kingdom

  • University of California, San Francisco-Fresno

    Fresno, California, 93701, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • VCU Health Clinical Research Services Unit

    Richmond, Virginia, 23298, United States

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37232, United States

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