We are looking for people diagnosed with non-alcoholic steatohepatitis (fatty liver)

This study is evaluating the safety and efficacy of Obeticholic Acid in people with non-alcoholic steatohepatitis (NASH)

Currently, there are no therapies approved for the treatment of NASH. The purpose of this study is to find out how safe and effective Obeticholic Acid may be in delaying specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis. 

Obeticholic Acid is a man-made version of a natural compound made in the liver called bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function.

Anticipated date that enrolment will close: 31 January 2022

Who can take part

Inclusion criteria:

  • Histologic evidence of NASH
  • Histologic evidence of fibrosis

Exclusion criteria:

  • Inability to safely undergo a liver biopsy.
  • Current or history of significant alcohol consumption (more than 2 units/day for females and more than 4 units/day for males, average) for a period of more than 3 consecutive months within 1 year before Screening
  • Prior or planned ileal resection, or prior (within 5 years) or planned bariatric surgery (eg, gastric bands, gastroplasty, roux-en-Y gastric bypass).
  • Evidence of other forms of known chronic liver disease including: Positive hepatitis B, Active hepatitis C virus infection, autoimmune hepatitis, overlap syndrome, Alcoholic liver disease, Wilson's disease, hemochromatosis, Alpha-1-antitrypsin (A1AT) deficiency, Prior known drug-induced liver injury, liver cancer, liver transplant, presence of cirrhosis. Or subjects with recent history (within 1 year) of significant atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, acute coronary syndrome, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, or peripheral vascular disease requiring intervention).

What is involved for you

  • Medical History
  • Physical Exam
  • Electrocardiogram (ECG)
  • Weight; Height; Blood Pressure; Pulse; Heart Rate
  • Health Questionnaires
  • Liver Ultrasound
  • Liver Biopsy
  • Blood Samples
check
Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2016.190
Virginia Bird
03 9342 8995
Zafirah Khan
03 9342 8995