At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 283 enrolled
Drug / intervention
obeticholic acid +1 moredrug
Likely dose
obeticholic acid 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis (NASH) Treatment (FLINT) Trial
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Dec 23, 2010·Updated Apr 6, 2018
In Brief
A Phase 2 clinical trial evaluating obeticholic acid and placebo for Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH). Completed, enrolled 283 participants across 9 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartMar 2011
Primary CompletionJan 2014
Study CompletionSep 2014
TodayJul 2026
First PostedDec 23, 2010
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.5 years ago
Interventions
obeticholic aciddrug
25 mg daily for 72 weeks
placebodrug
placebo capsule, 25 mg daily for 72 weeks