At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
10 mg Obeticholic Acid (OCA)from 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.
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
In Brief
A clinical study evaluating Placebo and 10 mg Obeticholic Acid (OCA) for Alcohol Consumption. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Consumption
CountriesUnited States
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartApr 2016
Primary CompletionSep 2019
TodayJul 2026
First PostedJan 13, 2016
Enrollment StartApr 1, 2016
Primary CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.5 years ago
Interventions
Placebodrug
1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
10 mg Obeticholic Acid (OCA)drug
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.