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

NASH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923154
• Other study ID #: MT-3995-J07
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: April 2019

Study information

• Verified date: September 2019
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• NASH
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• MT-3995

• Placebo

Locations

Country	Name	City	State
Japan	Investigational site	Kanagawa
Japan	Investigational site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in ALT		24 weeks
Secondary	Change from baseline in ALT		24 weeks
Secondary	Adverse events		From baseline to 72 weeks