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

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

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)