NCT02784444

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

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™)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Cirius Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

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

Interventions

Type	Name	Description
DRUG	MSDC-0602K	MSDC-0602K capsules
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2016-09-14
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-05-27
• Last updated: 2020-09-16
• Results posted: 2020-08-21

Locations

43 sites across 1 country: United States