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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR OBETICHOLIC ACID

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Clinical Trials for Obeticholic Acid

Trial ID Title Status Sponsor Phase Summary
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 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 Active, not recruiting Intercept Pharmaceuticals Phase 3 The investigational drug, Obeticholic Acid (OCA) is a modified bile acid. Bile acids are used by the body to help with digestion. It is hypothesized that regular treatment with OCA will improve liver function in persons with Primary Biliary Cirrhosis (PBC).
NCT01585025 Obeticholic Acid in Bile Acid Diarrhoea Completed Imperial College London Phase 2 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 6αethylchenodeoxycholic 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 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.
NCT01625026 Obeticholic Acid in Bariatric and Gallstone Disease Completed Sahlgrenska University Hospital, Sweden Phase 2 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.
NCT01865812 Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis Active, not recruiting Intercept Pharmaceuticals Phase 2 The purpose of this study is to determine if obeticholic acid (OCA) has an effect on cholesterol levels in the blood in patients with PBC.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Obeticholic Acid

Condition Name

Condition Name for Obeticholic Acid
Intervention Trials
Primary Biliary Cirrhosis 3
Liver Cirrhosis, Biliary 2
Obesity 2
Healthy 2
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Condition MeSH

Condition MeSH for Obeticholic Acid
Intervention Trials
Liver Cirrhosis, Biliary 5
Liver Cirrhosis 5
Fibrosis 5
Fatty Liver 4
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Clinical Trial Locations for Obeticholic Acid

Trials by Country

Trials by Country for Obeticholic Acid
Location Trials
United States 151
United Kingdom 17
Germany 11
Belgium 8
Australia 8
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Trials by US State

Trials by US State for Obeticholic Acid
Location Trials
Virginia 9
California 9
Texas 8
Missouri 7
Indiana 7
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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 1
Phase 3 4
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Obeticholic Acid
Clinical Trial Phase Trials
Recruiting 8
Completed 6
Active, not recruiting 4
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Clinical Trial Sponsors for Obeticholic Acid

Sponsor Name

Sponsor Name for Obeticholic Acid
Sponsor Trials
Intercept Pharmaceuticals 12
Sahlgrenska University Hospital, Sweden 2
University of Texas Southwestern Medical Center 1
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Sponsor Type

Sponsor Type for Obeticholic Acid
Sponsor Trials
Industry 12
Other 7
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
McKesson
Daiichi Sankyo
Express Scripts
Citi
UBS
Cerilliant
Covington
Accenture

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