FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
NCT05639543 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2026-05-05
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
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
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