Obeticholic acid

DRUG16 trials

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Imperial College Healthcare NHS Trust, Sahlgrenska University Hospital, Intercept Pharmaceuticals, Abhimanyu Garg

Conditions

Attenuated Familial Adenomatous PolyposisBarrett EsophagusCholestasisChronic DiarrhoeaColorectal CarcinomaDuodenal CarcinomaEsophageal AdenocarcinomaFamilial Adenomatous Polyposis

Early Phase 1

Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT

CompletedNCT03253276

University of AarhusPrimary Biliary Cirrhosis

Start: 2016-05-19End: 2018-09-20Updated: 2019-11-01

Phase 1

Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers

Sahlgrenska University HospitalObesity

Start: 2015-08-31End: 2021-06-30Target: 40Updated: 2020-08-25

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects

CompletedNCT04053023

GlaxoSmithKlineCholestasis

Start: 2019-08-27End: 2019-11-25Updated: 2020-07-24

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

CompletedNCT05133830

GlaxoSmithKlinePruritus

Start: 2021-11-23End: 2022-05-31Updated: 2022-11-08

Phase 2

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

CompletedNCT01265498

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)

Start: 2011-03-31End: 2014-09-30Updated: 2018-04-06

Obeticholic Acid in Bile Acid Diarrhoea

CompletedNCT01585025

Imperial College Healthcare NHS TrustChronic Diarrhoea, Primary Bile Acid Malabsorption, Secondary Bile Acid Malabsorption

Start: 2012-04-30End: 2014-02-28Updated: 2023-03-10

Obeticholic Acid in Bariatric and Gallstone Disease

CompletedNCT01625026

Sahlgrenska University HospitalGallstones, Obesity

Start: 2013-09-30End: 2016-04-30Updated: 2016-10-18

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

CompletedNCT01865812

Intercept PharmaceuticalsPrimary Biliary Cirrhosis

Start: 2013-12-03End: 2016-09-12Updated: 2022-08-24

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

CompletedNCT02430077

Abhimanyu GargFamilial Partial Lipodystrophy

Start: 2016-06-30End: 2022-12-31Updated: 2024-08-27

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

CompletedNCT02633956

Intercept PharmaceuticalsNonalcoholic Steatohepatitis

Start: 2015-12-04End: 2018-03-12Updated: 2018-06-04

An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls

Active, not recruitingNL-OMON47216

Academisch Medisch Centrumfatty liver disease non-alcoholic steatohepatitis Primary biliary cholangitis small bile duct injury

Start: 2017-07-13Target: 33Updated: 2024-02-28

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

TerminatedNCT04594694

Intercept PharmaceuticalsPrimary Biliary Cholangitis

Start: 2019-10-02End: 2025-10-14Updated: 2025-11-17

Obeticholic Acid for Prevention in Barrett's Esophagus

RecruitingNCT04939051

National Cancer Institute (NCI)Barrett Esophagus, Esophageal Adenocarcinoma

Start: 2024-01-03End: 2027-09-01Target: 30Updated: 2026-04-03

Testing Obeticholic Acid for Familial Adenomatous Polyposis

SuspendedNCT05223036

National Cancer Institute (NCI)Attenuated Familial Adenomatous Polyposis, Colorectal Carcinoma, Duodenal Carcinoma +1

Start: 2023-01-19End: 2029-02-21Target: 80Updated: 2026-04-03

Phase 3

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

TerminatedNCT02548351

Intercept PharmaceuticalsNon Alcoholic Steatohepatitis (NASH)

Start: 2015-09-22End: 2023-09-15Updated: 2024-10-01

Unknown Phase

Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

CompletedNCT03836937

Sir Salimullah Medical College Mitford HospitalNon-Alcoholic Fatty Liver Disease

Start: 2019-03-05End: 2021-12-31Updated: 2022-05-17

Related Papers

Abstract 2331: WNT/β-catenin modulation by activation of the farnesoid X receptor for interception of familial adenomatous polyposis-associated colorectal cancer

Cancer Research2025-04-21

NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.

2025-01-019 citations

Changes in abdominal adipose tissue depots assessed by MRI correlate with hepatic histologic improvement in non-alcoholic steatohepatitis.

2022-11-0829 citations

Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study.

2021-11-15109 citations

Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis

Clinical Gastroenterology and Hepatology2021-07-1587 citations

Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial.

2019-12-05919 citations

Impact of obeticholic acid on the lipoprotein profile in patients with non-alcoholic steatohepatitis

Journal of Hepatology2019-10-18128 citations

CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients

Liver International2019-08-12155 citations

REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis

Contemporary Clinical Trials2019-06-28121 citations

Obeticholic acid may increase the risk of gallstone formation in susceptible patients.

2019-06-2745 citations

An update on the pharmacological treatment of nonalcoholic fatty liver disease: Beyond lifestyle modifications

Clinical Liver Disease2018-04-0139 citations

Clinical and metabolic effects associated with weight changes and obeticholic acid in non‐alcoholic steatohepatitis

Alimentary Pharmacology & Therapeutics2018-01-1469 citations

Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial.

2014-11-071661 citations

The response of patients with bile acid diarrhoea to the farnesoid X receptor agonist obeticholic acid

Alimentary Pharmacology & Therapeutics2014-10-20163 citations