Ensayos clínicos

Inclusion Criteria:

• Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
• Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
• At least one of the following: a) history of variceal hemorrhage (more than 3 months prior to day 1) documented on endoscopy and requiring blood transfusion, b) history of at least moderate ascites (on physical exam or imaging) currently treated with diuretics.
• MELD score ≥12 and ≤20 during screening
• Albumin ≥2.5 g/dL during screening
• Serum creatinine ≤1.5 mg/dL during screening

Exclusion Criteria:

• Evidence of severe decompensation.
• Non-cirrhotic portal hypertension.
• Child-Pugh score ≥10.
• Current use of anticoagulants that affect prothrombin time or international normalized ratio.
• ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening.
• Initiation or discontinuation of non-selective beta blockers within 1 month of screening.
• Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision.
• Alpha-fetoprotein >50 ng/mL in the last year.
• History of hepatocellular carcinoma (HCC) or evidence of HCC.
• History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured.
• Prior liver transplant.
• Uncontrolled diabetes mellitus (HbA1c >9%).
• Change in diabetes medications or vitamin E within 3 months of screening.
• Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery.
• Symptoms of biliary colic unless resolved following cholecystectomy.
• History of significant alcohol consumption within the past 5 years.
• Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters.
• Prolongation of screening (pre-treatment) QTcF interval of >500 msecs, or history or presence of clinically concerning cardiac arrhythmias.
• Significant systemic or major illness other than liver disease.
• Known human immunodeficiency virus (HIV) infection.
• Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement.