Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
Phase 2
Completed
- Conditions
- NASH
- Interventions
- Drug: MT-3995Drug: Placebo
- Registration Number
- NCT02923154
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT-3995 MT-3995 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent change from baseline in ALT 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse events From baseline to 72 weeks Change from baseline in ALT 24 weeks
Trial Locations
- Locations (1)
Investigational site
🇯🇵Osaka, Japan