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A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH

NCT02784444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2020-09-16

Study results available
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Summary

This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.

Conditions

  • Non-alcoholic Fatty Liver Disease
  • Non-alcoholic Steatohepatitis
  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

MSDC-0602K

MSDC-0602K capsules

DRUG

Placebo

Placebo capsules

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • Cirius Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Dittrich, MD · Cirius Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784444 on ClinicalTrials.gov