NASH Study


Viable Clinical Research is conducting a clinical research study evaluating the efficacy and safety of obeticholic acid in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: All
Accepts Healthy Volunteers: No


Inclusion Criteria:

  1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading.

Exclusion Criteria:

  1. Current or past history of hepatic decompensation such as clinically significant ascites, hepatic encephalopathy (HE), or variceal bleeding;
  2. Current or past history of CP score > 7 points;
  3. Model for End-stage Liver Disease (MELD) score > 12;
  4. ALT > 5 X ULN;
  5. Calculated creatinine clearance < 60 ml/min using Cockcroft-Gault method;
  6. Hemoglobin A1c > 9.5%;
  7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC);
  8. History of liver transplant, or current placement on a liver transplant list.

Contact the Viable Clinical Research team regarding this study.