NCT01265498

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis (NASH) Treatment (FLINT) Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).

Detailed description

To evaluate whether treatment with obeticholic acid, 25 mg daily for 72 weeks compared to treatment with placebo, improves the severity of nonalcoholic fatty liver disease (NAFLD) as determined from hepatic histology.

Conditions

• Nonalcoholic Fatty Liver Disease (NAFLD)
• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	obeticholic acid	25 mg daily for 72 weeks
DRUG	placebo	placebo capsule, 25 mg daily for 72 weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-01-01
• Completion: 2014-09-01
• First posted: 2010-12-23
• Last updated: 2018-04-06
• Results posted: 2015-08-21

Locations

9 sites across 1 country: United States