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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602K in Patients With NASH (EMMINENCE™)

Clinical Trial 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.

Clinical Trial Description

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. Visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12 months, with one 2- week follow-up visit.

Safety will be assessed by monitoring of vital signs, 12 lead electrocardiogram (ECG), physical examinations, safety labs, and adverse events (AEs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02784444
Study type Interventional
Source Cirius Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date September 14, 2016
Completion date June 2019
View Details
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