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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Obeticholic Acid placebo Clear all
Completed Phase 2 Interventional Results available

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

NCT01265498
View directory record Official record
Conditions
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Interventions
obeticholic acid, placebo
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
18 Years and older
Enrollment
283 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
9
States / cities
San Diego, California • San Francisco, California • Indianapolis, Indiana + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 5, 2018 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

NCT06247735
View directory record Official record
Conditions
Primary Biliary Cholangitis
Interventions
K-808 (Dose A), K-808 (Dose B), Placebo
Drug
Lead sponsor
Kowa Research Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
21
States / cities
Tucson, Arizona • Coronado, California • Los Angeles, California + 18 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 3 Interventional Results available

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

NCT03439254
View directory record Official record
Conditions
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Interventions
Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
919 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
120
States / cities
Dothan, Alabama • Madison, Alabama • Chandler, Arizona + 96 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2023 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 4 Interventional Results available

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

NCT03633227
View directory record Official record
Conditions
Liver Cirrhosis, Biliary
Interventions
Obeticholic Acid (OCA), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 85 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
11
States / cities
Rialto, California • Sacramento, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2022 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

NCT05239468
View directory record Official record
Conditions
Primary Biliary Cholangitis
Interventions
Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg, Obeticholic Acid placebo, Bezafibrate Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
17
States / cities
Birmingham, Alabama • Coronado, California • Mission Hills, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

NCT02177136
View directory record Official record
Conditions
Primary Sclerosing Cholangitis (PSC)
Interventions
Obeticholic Acid (OCA), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
33
States / cities
Phoenix, Arizona • Sacramento, California • Aurora, Colorado + 23 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2021 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

NCT00570765
View directory record Official record
Conditions
Liver Cirrhosis, Biliary
Interventions
Placebo, Obeticholic Acid (OCA)
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2017
U.S. locations
4
States / cities
Detroit, Michigan • Houston, Texas • Richmond, Virginia + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2021 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

NCT02430077
View directory record Official record
Conditions
Familial Partial Lipodystrophy
Interventions
Obeticholic Acid, Placebo
Drug
Lead sponsor
Abhimanyu Garg
Other
Eligibility
18 Years to 70 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
2
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 26, 2024 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 4 Interventional Results available

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

NCT02308111
View directory record Official record
Conditions
Liver Cirrhosis, Biliary
Interventions
Obeticholic Acid (OCA), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
334 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2021
U.S. locations
43
States / cities
Phoenix, Arizona • Los Angeles, California • Rialto, California + 32 more
Source: ClinicalTrials.gov public record
Updated Mar 8, 2023 · Synced Sep 25, 2026, 10:35 AM EDT
Recruiting Phase 2 Interventional

Obeticholic Acid for Prevention in Barrett's Esophagus

NCT04939051
View directory record Official record
Conditions
Barrett Esophagus, Esophageal Adenocarcinoma
Interventions
Biospecimen Collection, Esophageal Biopsy, Esophagogastroduodenoscopy, Liver Ultrasonographic Elastography, Obeticholic Acid, Placebo Administration, Questionnaire Administration
Procedure · Biological · Drug + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
8
States / cities
Kansas City, Kansas • Ann Arbor, Michigan • St Louis, Missouri + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 2 Interventional Results available

Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

NCT02039219
View directory record Official record
Conditions
Alcoholic Hepatitis
Interventions
Placebo, 10 mg Obeticholic Acid (OCA)
Drug
Lead sponsor
Naga P. Chalasani
Other
Eligibility
21 Years and older
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
4
States / cities
Indianapolis, Indiana • Rochester, Minnesota • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 27, 2020 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

NCT02654236
View directory record Official record
Conditions
Alcohol Consumption
Interventions
Placebo, 10 mg Obeticholic Acid (OCA)
Drug
Lead sponsor
Suthat Liangpunsakul
Other
Eligibility
21 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2019
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Apr 24, 2023 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 2 Interventional Results available

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

NCT00550862
View directory record Official record
Conditions
Liver Cirrhosis, Biliary
Interventions
INT-747, Ursodeoxycholic Acid (URSO), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
165 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
13
States / cities
Gainesville, Florida • Miami, Florida • Boston, Massachusetts + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2024 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 3 Interventional Results available

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

NCT02548351
View directory record Official record
Conditions
Non Alcoholic Steatohepatitis (NASH)
Interventions
Obeticholic Acid, Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 85 Years
Enrollment
2,477 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
175
States / cities
Birmingham, Alabama • Dothan, Alabama • Chandler, Arizona + 116 more
Source: ClinicalTrials.gov public record
Updated Sep 30, 2024 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

NCT02633956
View directory record Official record
Conditions
Nonalcoholic Steatohepatitis
Interventions
Obeticholic Acid, Atorvastatin, Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 85 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
22
States / cities
Phoenix, Arizona • La Jolla, California • Rialto, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2018 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 2 Interventional Results available

Study of INT-747 in Patients With Diabetes and Presumed NAFLD

NCT00501592
View directory record Official record
Conditions
Diabetes Mellitus, Type II, Fatty Liver
Interventions
INT-747, Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
4
States / cities
Chula Vista, California • San Diego, California • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2012 · Synced Sep 25, 2026, 10:35 AM EDT
Terminated Phase 2 Interventional

Testing Obeticholic Acid for Familial Adenomatous Polyposis

NCT05223036
View directory record Official record
Conditions
Attenuated Familial Adenomatous Polyposis, Colorectal Carcinoma, Duodenal Carcinoma, Familial Adenomatous Polyposis
Interventions
Biopsy Procedure, Biospecimen Collection, Gastrointestinal Endoscopy, Obeticholic Acid, Placebo Administration, Questionnaire Administration
Procedure · Biological · Drug + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
6
States / cities
Scottsdale, Arizona • Kansas City, Kansas • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Sep 25, 2026, 10:35 AM EDT
Completed Phase 3 Interventional Results available

Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

NCT01473524
View directory record Official record
Conditions
Primary Biliary Cirrhosis
Interventions
Obeticholic Acid (OCA), Placebo
Drug
Lead sponsor
Intercept Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
217 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
15
States / cities
Sacramento, California • San Diego, California • Aurora, Colorado + 11 more
Source: ClinicalTrials.gov public record
Updated May 5, 2021 · Synced Sep 25, 2026, 10:35 AM EDT