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OpenTrials
Completed

NCT Number: NCT02923154

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

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.

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Key information

Conditions

NASH

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site, Kanagawa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MT-3995

Drug

Placebo

Drug

Primary outcomes

  1. Percent change from baseline in ALT

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in ALT

    Time frame: 24 weeks

  2. Adverse events

    Time frame: From baseline to 72 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 4, 2016
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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