Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)

An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)

The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.

Inclusion Criteria:

• Subjects diagnosed with NASH before randomization
• Subjects who conducts diet or exercise therapy at the beginning of run in period.
• Subjects who has given full and adequate information of the protocol and with written informed consent

Exclusion Criteria:

• Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
• Subjects with alcohol dependence or previously diagnosed with alcohol dependence
• Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
• Presence, history, or family history of long QT syndrome or Torsades de Pointes
• Subjects with heart failure (New York Heart Association Class III-IV)