An interventional study of Placebo and 10 mg Obeticholic Acid (OCA) in Alcohol Consumption, sponsored by Suthat Liangpunsakul. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Suthat Liangpunsakul · Not applicable, Interventional, and Other
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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 30 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →This is the only study on the registry with Suthat Liangpunsakul as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Heavy Drinkers on placebo
Drug: Placebo
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.
Drug: 10 mg Obeticholic Acid (OCA)
Non-drinking healthy controls
1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
Change in FGF19 Levels to Determine Effect of FXR
Time frame: Baseline to 28 days
Change in Fasting Serum Bile Salt Levels
Time frame: Baseline to 28 days
Change in Oxidative Stress Level by Measuring Malondialdehyde
Time frame: Baseline to 28 days
Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance
Time frame: Baseline to 28 days
Change in Gut Permeability Through Lactulose/Mannitol Test
This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Plasma LPS
Time frame: Baseline to 28 days
Change in Intestinal Inflammation by Measuring Stool Calprotectin
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Time frame: Baseline to 28 days
Change in Bacterial Translocation Through Measures of Serum sCD14
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-6
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-8
Time frame: Baseline to 28 days
Change in Activation of Innate Immunity Through Measures of IL-1
Time frame: Baseline to 28 days
| Milestone | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Started | 9 | 6 | 15 |
| Completed | 9 | 6 | 13 |
| Not completed | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
| µg/ml | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 2.56 ± 0.79 | 2.79 ± 3.44 | 1.03 ± 1.46 |
| Day 28 | 1.54 ± 1.77 | 3.30 ± 4.03 | 1.38 ± 0.58 |
No measurements were reported for this outcome.
This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability
| lactulose/mannitol ratio | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 0.05 ± 0.03 | 0.04 ± 0.01 | 0.04 ± 0.02 |
| Day 28 | 0.05 ± 0.03 | 0.07 ± 0.05 | 0.05 ± 0.05 |
| Pg/ml | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 40.22 ± 9.52 | 58.73 ± 13.3 | 58.28 ± 28.8 |
| Day 28 | 47.84 ± 23.1 | 47.0 ± 22.3 | 19.99 ± 16.93 |
No measurements were reported for this outcome.
| Pg/ml | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 6.53 ± 3.52 | 8.99 ± 4.39 | 6.91 ± 3.36 |
| Day 28 | 6.36 ± 3.00 | 7.97 ± 4.08 | 2.89 ± 3.27 |
| µg/ml | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 2.56 ± 0.79 | 3.05 ± 0.91 | 2.09 ± 0.44 |
| Day 28 | 2.28 ± 0.68 | 2.28 ± 0.57 | 1.38 ± 0.58 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
| Pg/ml | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| Baseline | 1.90 ± 0.28 | 1.78 ± 0.24 | 1.77 ± 0.56 |
| Day 28 | 1.76 ± 0.32 | 1.45 ± 0.78 | 1.07 ± 0.30 |
Collected over Approximately 2.5 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| 10 mg Obeticholic Acid (OCA) | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Non-drinking Controls | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls |
|---|---|---|---|
| HeadacheNervous system disorders | 1/9 | 2/6 | 0/15 |
| Upper respiratory tract congestionRespiratory, thoracic and mediastinal disorders | 0/9 | 1/6 | 0/15 |
| Burns first degreeInjury, poisoning and procedural complications | 0/9 | 1/6 | 0/15 |
| NauseaGastrointestinal disorders | 1/9 | 1/6 | 0/15 |
| DiarrheaGastrointestinal disorders | 1/9 | 0/6 | 0/15 |
| Thirst decreasedGeneral disorders | 1/9 | 0/6 | 0/15 |
| Gastrointestinal painGastrointestinal disorders | 1/9 | 0/6 | 0/15 |
| Aspartate aminotransferase increasedInvestigations | 1/9 | 0/6 | 0/15 |
| Alanine aminotransferase increasedInvestigations | 1/9 | 0/6 | 0/15 |
| throat irritationRespiratory, thoracic and mediastinal disorders | 1/9 | 0/6 | 0/15 |
| Age, Continuous(Years) | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls | Total |
|---|---|---|---|---|
| Mean | 31 (21 to 63) | 49 (30 to 65) | 47 (27 to 60) | 39 (21 to 65) |
| Sex: Female, Male(Participants) | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls | Total |
|---|---|---|---|---|
| Female | 5 | 2 | 10 | 17 |
| Male | 4 | 4 | 5 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 9 | 6 | 14 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 4 | 13 |
| White | 3 | 2 | 7 | 12 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | 10 mg Obeticholic Acid (OCA) | Non-drinking Controls | Total |
|---|---|---|---|---|
| United States | 9 | 6 | 15 | 30 |
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