drugset / Trial / NCT05639543
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
RandomizedSingle-groupTriple-blindTreatment
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).
Timeline
- Start
- 2022-12-15
- Primary completion
- 2026-02-10
- Completion
- 2026-02-10
Outcome
Outcome not reported
Stopped (Business): “Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | INT-787 | Unknown | — | — |