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

Mitsubishi Tanabe Pharma Corporation1 site in 1 country48 target enrollmentSeptember 2016

ConditionsNASH

InterventionsMT-3995 Placebo

DrugsMT-3995 Placebo

Overview

Phase: Phase 2
Intervention: MT-3995
Conditions: NASH
Sponsor: Mitsubishi Tanabe Pharma Corporation
Enrollment: 48
Locations: 1
Primary Endpoint: Percent change from baseline in ALT
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

April 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mitsubishi Tanabe Pharma Corporation

Responsible Party

Sponsor

Eligibility 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)