Clinical Trials

Inclusion Criteria:

• Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
• Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
• Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥ 1 of the following risk factors:
  • Obesity (BMI ≥ 30 kg/m^2);
  • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria;
  • ALT >1.5 × upper limit of normal (ULN).
• For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
• Stable body weight.
• Age ≥18 years.
• Female subjects of childbearing potential must use ≥ 1 effective method of contraception during the study and until 30 days following the last dose of investigational product. Effective methods of contraception are considered to be those listed below:
  • Barrier method; i.e., condom (male or female) with spermicide or diaphragm with spermicide;
  • Intrauterine device;
  • Vasectomy (partner);
  • Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection);
  • Abstinence (defined as refraining from heterosexual intercourse).
• Must provide written informed consent and agree to comply with the study protocol.

Exclusion Criteria:

• Model for End-stage Liver Disease (MELD) score > 12.
• ALT ≥ 10 × ULN.
• HbA1c > 9.5%.
• Total bilirubin > 1.5 mg/dL.
• Evidence of other known forms of known 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).
• History of liver transplant, or current placement on a liver transplant list.
• Current or history of significant alcohol consumption.
• Prior or planned ileal resection, or prior or planned bariatric surgery.
• Histological presence of cirrhosis.
• History of biliary diversion.
• Known positivity for human immunodeficiency virus infection.
• Acute cholecystitis or acute biliary obstruction.
• BMI > 45 kg/m^2.