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

> **NCT05639543** · PHASE2 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 67 (actual)

## Conditions studied

- Alcohol Associated Hepatitis

## Interventions

- **DRUG:** INT-787
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05639543
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-12-15
- **Primary completion:** 2026-02-10
- **Final completion:** 2026-02-10
- **Target enrollment:** 67 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05639543

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05639543, "FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study". Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/clinical/NCT05639543. Licensed CC0.

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