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FXR Agonist

10 mg Obeticholic Acid (OCA) for Alcohol Consumption

N/A
Waitlist Available
Led By Suthat Liangpunsakul, MD
Research Sponsored by Suthat Liangpunsakul
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 days
Awards & highlights

Study Summary

This trial will test if heavy drinking affects a liver pathway that may lead to injury in some patients.

Eligible Conditions
  • Alcohol Consumption

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Change in FGF19 Levels to Determine Effect of FXR
Secondary outcome measures
Change in Activation of Innate Immunity Through Measures of IL-1
Change in Activation of Innate Immunity Through Measures of IL-6
Change in Activation of Innate Immunity Through Measures of IL-8
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 10 mg Obeticholic Acid (OCA)Experimental Treatment1 Intervention
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.
Group II: Non-drinking ControlsActive Control1 Intervention
Non-drinking healthy controls
Group III: PlaceboPlacebo Group1 Intervention
Heavy Drinkers on placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
10 mg Obeticholic Acid (OCA)
2016
N/A
~30

Find a Location

Who is running the clinical trial?

Suthat LiangpunsakulLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,954 Total Patients Enrolled
Intercept PharmaceuticalsIndustry Sponsor
27 Previous Clinical Trials
16,820 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research been conducted previously, or is it a pioneering endeavor?

"Ever since its first trial in 2015, sponsored by Intercept Pharmaceuticals and involving 2480 patients, 10 mg Obeticholic Acid (OCA) has been under research. Following the successful Phase 3 drug approval obtained after this initial study, 6 more trials for it are now underway across 31 nations with 142 cities involved."

Answered by AI

What precedent exists in terms of research into the effects of 10 mg Obeticholic Acid (OCA)?

"Currently, 6 studies are being conducted to evaluate 10 mg Obeticholic Acid (OCA), two of which have reached the third phase. Despite originating in Changchun Jilin, 422 locations worldwide are running trials for OCA."

Answered by AI

Is this experiment open to individuals below the age of 70?

"This trial is open to volunteers aged between 21 and 65. Those younger than 21 or older than 65 will find 20 trials and 169 trials, respectively, that they are eligible for."

Answered by AI

Are there any participants being enrolled in this study at the present time?

"Per information available on clinicaltrials.gov, this healthcare research is actively seeking volunteers. It was initially published to the site on April 1st 2016 and its particulars were last amended nine days ago in April 2022."

Answered by AI

To what extent is this medical experiment being participated in?

"Affirmative, information published on clinicaltrials.gov suggests that this medical research is currently recruiting for 45 participants across one site. The trial was first made available to the public on April 1st 2016 and has been recently updated as of April 9th 2022."

Answered by AI

Could I potentially gain admittance to this experiment?

"This research is recruiting 45 individuals with a history of alcohol consumption who are between the ages 21 and 65 years old. Eligible participants must not have drank any alcohol within 3 months before screening, while female applicants should be willing to practice contraception during treatment."

Answered by AI
~3 spots leftby Mar 2025