# Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

> **NCT02548351** · PHASE3 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 2477 (actual)

## Conditions studied

- Non Alcoholic Steatohepatitis (NASH)

## Interventions

- **DRUG:** Obeticholic Acid
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02548351
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2015-09-22
- **Primary completion:** 2023-09-15
- **Final completion:** 2023-09-15
- **Target enrollment:** 2477 (ACTUAL)
- **Why stopped:** The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. Sponsor decided to terminate 747-303 before the planned completion date.
- **Last updated:** 2024-10-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02548351

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02548351, "Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT02548351. Licensed CC0.

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