A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

Inclusion Criteria

• An informed consent document must be signed and dated by the subject
• Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive
• Male or female with presence of NASH by:
• Histologic evidence on a historical liver biopsy within 24 months of Screening consistent with NASH with fibrosis (no cirrhosis), and elevated ALT at Screening AND Screening MRI PDFF with >8 % steatosis OR
• Phenotypic diagnosis of NASH based on elevated ALT and diagnosis of T2DM or pre-diabetes AND Screening MRI PDFF with >8 % steatosis
• Body mass index (BMI) >25 kg/m2; for Asian-Americans, BMI >23 kg/m2
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
• Subject must be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol

Exclusion Criteria

• Laboratory Screening Results:
• Total bilirubin > ULN (normal range 0.2-1.2 mg/dL)
• Total white blood cells (WBC) 1.2
• Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise
• Serum creatinine >2 mg/dL or creatinine clearance 2xULN
• Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 μmol/L)
• Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
• Any condition possibly affecting drug absorption (eg, gastrectomy <3 years prior to Screening)
• Subject has received an investigational agent or vaccine within 30 days, or a biological product within 3 months or 5 elimination half-lives (whichever is longer) prior to the planned intake of study drug. NOTE: Flu vaccine will be allowed upon Medical Monitor's approval
• Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least three months prior to Screening are allowed. No dose modification during the study will be allowed.
• Current use of fibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate
• Clinically significant history of drug sensitivity or allergy, as determined by the PI
• Uncontrolled diabetes mellitus (ie, HbA1c ≥9% or higher) 60 days prior to Day 1
• Subjects with contraindications to MRI imaging, or not being able to have the MRI performed