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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02923154

Enrollment

Registered

2016-10-04

Start date

2016-09-30

Completion date

2019-04-30

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH

Keywords

NASH

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.

Interventions

DRUGMT-3995

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in ALT	24 weeks

Secondary

Measure	Time frame
Change from baseline in ALT	24 weeks
Adverse events	From baseline to 72 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026