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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: NASH

Treatments: Drug: MT-3995; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02923154

MT-3995-J07

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

MT-3995

Experimental group

Treatment:

Drug: MT-3995

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo