Clinical Trial Details

Trial ID: L0152
Source ID: NCT02784444
Associated Drug: MSDC-0602K
Title: A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
Acronym: EMMINENCE
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02784444/results
Conditions: Non-alcoholic Fatty Liver Disease|Non-alcoholic Steatohepatitis|NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: MSDC-0602K|Drug: Placebo
Outcome Measures: Number of Participants With Hepatic Histological Improvement in NAS|Number of Subjects With Resolution of NASH With no Worsening of Fibrosis at 12 Months.|Number of Subjects With Improvement of Fibrosis (CRN Staging Score) by at Least 1 Stage With no Worsening of NASH at 12 Months.|Mean Change From Baseline in NAFLD Activity Score (NAS)|Mean Change From Baseline in CRN Steatosis Score|Mean Change From Baseline in CRN Inflammation Score|Mean Change From Baseline in CRN Ballooning Score|Mean Change From Baseline in CRN Fibrosis Staging Score
Sponsor/Collaborators: Cirius Therapeutics, Inc.|Chiltern International Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 392
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: September 14, 2016
Completion Date: June 2019
Results First Posted: August 21, 2020
Last Update Posted: September 16, 2020
Locations: Chandler, Arizona, United States|Tucson, Arizona, United States|Chula Vista, California, United States|Fresno, California, United States|Garden Grove, California, United States|Huntington Park, California, United States|La Mesa, California, United States|Los Angeles, California, United States|Los Angeles, California, United States|Poway, California, United States|Rialto, California, United States|San Diego, California, United States|Englewood, Colorado, United States|Gainesville, Florida, United States|Hialeah, Florida, United States|Inverness, Florida, United States|Lakewood Ranch, Florida, United States|Miami Lakes, Florida, United States|Wellington, Florida, United States|Marietta, Georgia, United States|Indianapolis, Indiana, United States|Bastrop, Louisiana, United States|New Orleans, Louisiana, United States|New Orleans, Louisiana, United States|West Monroe, Louisiana, United States|Flowood, Mississippi, United States|Brooklyn, New York, United States|New York, New York, United States|Fayetteville, North Carolina, United States|Greenville, North Carolina, United States|Statesville, North Carolina, United States|Providence, Rhode Island, United States|Germantown, Tennessee, United States|Hermitage, Tennessee, United States|Arlington, Texas, United States|Dallas, Texas, United States|Fort Sam Houston, Texas, United States|Houston, Texas, United States|Live Oak, Texas, United States|Rollingwood, Texas, United States|San Antonio, Texas, United States|San Antonio, Texas, United States|Richmond, Virginia, United States
URL: https://ClinicalTrials.gov/show/NCT02784444

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D233 MSDC-0602K Chemical drug -- MPC modulator Antidiabetic drug Failed in clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details