# Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

> **NCT03439254** · PHASE3 · COMPLETED · sponsor: **Intercept Pharmaceuticals** · enrollment: 919 (actual)

## Conditions studied

- Compensated Cirrhosis
- Nonalcoholic Steatohepatitis

## Interventions

- **DRUG:** Obeticholic acid (10 mg)
- **DRUG:** Obeticholic acid (10 mg to 25 mg)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03439254
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-08-30
- **Primary completion:** 2022-09-08
- **Final completion:** 2022-09-08
- **Target enrollment:** 919 (ACTUAL)
- **Last updated:** 2023-10-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03439254

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03439254, "Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT03439254. Licensed CC0.

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