CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 392 enrolled
Drug / intervention
MSDC-0602K +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02784444
NCT02784444Phase 2Completed
CompareCT.gov

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™)

Cirius Therapeutics, Inc.·interventional·Posted May 27, 2016·Updated Sep 16, 2020

In Brief

A Phase 2 clinical trial evaluating MSDC-0602K and Placebo for Non-alcoholic Fatty Liver Disease and 2 related conditions. Completed, enrolled 392 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
CountriesUnited States
CollaboratorsChiltern International Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 27, 2016
Enrollment StartSep 14, 2016
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.1 years ago

Interventions

MSDC-0602Kdrug

MSDC-0602K capsules

Placebodrug

Placebo capsules