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Last Updated: December 6, 2022

CLINICAL TRIALS PROFILE FOR OBETICHOLIC ACID


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All Clinical Trials for Obeticholic Acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00570765 ↗ Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC) Completed Intercept Pharmaceuticals Phase 2 2008-01-17 The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
NCT01265498 ↗ The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2011-03-01 Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).
NCT01473524 ↗ Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis Completed Intercept Pharmaceuticals Phase 3 2012-01-01 The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
NCT01585025 ↗ Obeticholic Acid in Bile Acid Diarrhoea Completed Imperial College London Phase 2 2012-04-01 The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6╬▒ethylchenodeoxycholic acid or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective treatment.
NCT01625026 ↗ Obeticholic Acid in Bariatric and Gallstone Disease Completed Medical University of Vienna Phase 2 2013-09-01 By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Obeticholic Acid

Condition Name

Condition Name for Obeticholic Acid
Intervention Trials
Primary Biliary Cholangitis 5
Primary Biliary Cirrhosis 4
Liver Cirrhosis, Biliary 4
Healthy 2
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Condition MeSH

Condition MeSH for Obeticholic Acid
Intervention Trials
Liver Cirrhosis, Biliary 12
Liver Cirrhosis 8
Fibrosis 8
Cholangitis 7
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Clinical Trial Locations for Obeticholic Acid

Trials by Country

Trials by Country for Obeticholic Acid
Location Trials
United States 186
United Kingdom 30
Germany 22
Canada 22
Australia 16
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Trials by US State

Trials by US State for Obeticholic Acid
Location Trials
Texas 11
Virginia 10
Florida 9
California 9
Missouri 8
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Clinical Trial Progress for Obeticholic Acid

Clinical Trial Phase

Clinical Trial Phase for Obeticholic Acid
Clinical Trial Phase Trials
Phase 4 3
Phase 3 5
Phase 2 16
[disabled in preview] 8
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Clinical Trial Status

Clinical Trial Status for Obeticholic Acid
Clinical Trial Phase Trials
Completed 13
Recruiting 11
Not yet recruiting 4
[disabled in preview] 5
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Clinical Trial Sponsors for Obeticholic Acid

Sponsor Name

Sponsor Name for Obeticholic Acid
Sponsor Trials
Intercept Pharmaceuticals 16
GlaxoSmithKline 2
National Cancer Institute (NCI) 2
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Sponsor Type

Sponsor Type for Obeticholic Acid
Sponsor Trials
Industry 21
Other 12
NIH 4
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