Ensayos clínicos

Inclusion Criteria:

1. 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.
2. Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
3. 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.

4. MELD ≤20 with at least 30% having MELD ≥15 and ≤20

5. Albumin ≥2.5 g/dL during screening
6. Serum creatinine ≤1.5 mg/dL during screening

Exclusion Criteria:

1. Recent reversible elevations in serum creatinine do not meet exclusionary criteria of acute kidney injury if resolved
2. Evidence of severe decompensation
3. Non-cirrhotic portal hypertension
4. Up to 2 variceal hemorrhages within past 12 months is acceptable
5. Child-Pugh score ≥10
6. Current use of anticoagulants that affect prothrombin time or international normalized ratio
7. ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening
8. Initiation or discontinuation of non-selective beta blockers within 1 month of screening
9. Placement or revision of transjugular intrahepatic portosystemic shunt within 6 months is acceptable
10. Alpha-fetoprotein >50 ng/mL in the last year
11. History of hepatocellular carcinoma (HCC) or evidence of HCC
12. History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
13. Prior liver transplant
14. Lactulose is not required to be stable (since standard of care is to titrate the dose when diarrhea occurs)
15. Uncontrolled diabetes mellitus (HbA1c >9%)
16. Diabetes medications should be stable within 3 months of screening except for medications titrated to blood glucose
17. Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
18. Symptoms of biliary colic unless resolved following cholecystectomy
19. History of significant alcohol consumption within the past 5 years
20. Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters
21. Prolongation of screening (pre-treatment) QTcF interval of >500 msecs, or history or presence of clinically concerning cardiac arrhythmias
22. Significant systemic or major illness other than liver disease
23. Known human immunodeficiency virus (HIV) infection
24. 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