NCT02923154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

October 2, 2016

Last Update Submit

September 4, 2019

Conditions

NASH

Keywords

NASH

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in ALT

    24 weeks

Secondary Outcomes (2)

  • Change from baseline in ALT

    24 weeks

  • Adverse events

    From baseline to 72 weeks

Study Arms (2)

MT-3995

EXPERIMENTAL
Drug: MT-3995

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MT-3995DRUG
MT-3995
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational site

Kanagawa, Japan

Location

Investigational site

Osaka, Japan

Location

MeSH Terms

Interventions

apararenone

Study Officials

  • General Manager

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

JP(2)