drugset / Trial / NCT05639543

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

NCT05639543 ↗

Phase 2 Terminated 67 enrolled Intercept Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Comparator INT-787 Unknown — —

Indications