NCT03439254

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 919 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Conditions

• Compensated Cirrhosis
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Obeticholic acid (10 mg)	Tablets administered orally once daily.
DRUG	Obeticholic acid (10 mg to 25 mg)	Tablets administered orally once daily.
DRUG	Placebo	Tablets administered orally once daily.

Timeline

• Start date: 2017-08-30
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2018-02-20
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

192 sites across 12 countries: United States, Australia, Canada, France, Germany, Hungary, New Zealand, Poland, Puerto Rico, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study