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

Primary Purpose

NASH

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MT-3995
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH focused on measuring NASH

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-3995

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline in ALT

Secondary Outcome Measures

Change from baseline in ALT
Adverse events

Full Information

First Posted
October 2, 2016
Last Updated
September 4, 2019
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02923154
Brief Title
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
Official Title
An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH
Keywords
NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-3995
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-3995
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent change from baseline in ALT
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in ALT
Time Frame
24 weeks
Title
Adverse events
Time Frame
From baseline to 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Kanagawa
Country
Japan
Facility Name
Investigational site
City
Osaka
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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