FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alcohol Associated Hepatitis

In brief

The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).

Key facts

Study ID

NCT05639543

Run by

Intercept Pharmaceuticals

People needed

67

Starts

2022-12-15

Expected to finish

2026-02-10

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 18 to 65 years (inclusive)
• Clinical diagnosis of sAH based on all the following:
• 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
• Serum total bilirubin >3.0 mg/dL
• Aspartate aminotransferase (AST) ≥50 U/L
• AST/Aspartate aminotransferase (ALT) ratio ≥1.5
• Onset of jaundice within prior 8 weeks
• Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
• Cohort 5 and Cohort 6: mDF ≥32
• Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
• 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

You may not qualify if…

• Participants taking products containing obeticholic acid in the 30 days prior to randomization
• Participants taking >2 doses of systemic corticosteroids within 30 days prior to randomization.
• Participants who have been inpatient at a referral hospital for >7 days prior to transfer.
• Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
• Abstinence from alcohol consumption for >2 months before Day 1.
• AST or ALT >400 U/L.
• Cohort 1 through Cohort 4: mDF <32 or >70.
• Cohort 5 and Cohort 6: mDF <32
• Cohort 1 through Cohort 4: MELD score <18 or >25.
• Cohort 5 and Cohort 6: MELD <21 or >30
• 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.
• Current or previous history of hepatocellular carcinoma (HCC)
• History of liver transplantation or currently listed for liver transplant
• Note: Additional protocol defined Inclusion/Exclusion criteria apply.

Where it is running

• University of California, San Francisco-Fresno — Fresno, California, United States
• Stanford Healthcare — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Clinical Translational Research Site — Miami, Florida, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Northwell Health Center for Liver Disease and Transplantation — Manhasset, New York, United States
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt Digestive Disease Center — Nashville, Tennessee, United States
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• VCU Health Clinical Research Services Unit — Richmond, Virginia, United States
• CHU Angers — Angers, France
• Hopital Beaujon — Clichy, France
• Hopital Claude Huriez — Lille, France
• Hopital Pitie Salpetriere — Paris, France
• Hopital Rangueil — Toulouse, France

Full record on ClinicalTrials.gov

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