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

NCT05639543 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-05

No results posted yet for this study

Summary

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).

Conditions

  • Alcohol Associated Hepatitis

Interventions

DRUG

INT-787

Blinded Study Drug

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2026-02-10
Completion
2026-02-10
FDA Drug
Yes

Countries

  • United States
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639543 on ClinicalTrials.gov