Clinical Trial Details

Trial ID: L0219
Source ID: NCT02912260
Associated Drug: MGL-3196
Title: Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Unknown status
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis
Interventions: Drug: MGL-3196|Drug: Placebo
Outcome Measures: Change from baseline in hepatic fat fraction assessed by MRI-PDFF|Two-point reduction in Non-alcoholic fatty liver disease NASH CRN (NAFLD) activity score (NAS)|Resolution of Non-alcoholic steatohepatitis (NASH) (ballooning = 0; inflammation = 0 to 1) as determined by the NASH CRN NAS score|Improvement in fibrosis by at least 1 stage with no worsening of steatohepatitis|Change from baseline in hepatic fat fraction|Safety and tolerability of MGL-3196 based on Adverse Events and Changes in Laboratory Values|Effect on high-sensitivity C-reactive protein (hsCRP)|Effect on serum alanine aminotransferase (ALT)|Effect on aspartate aminotransferase (AST)|Effect on lipid parameters|Effect on NASH and fibrosis biomarkers
Sponsor/Collaborators: Madrigal Pharmaceuticals, Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 125
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 2016
Completion Date: April 2018
Results First Posted: --
Last Update Posted: December 19, 2017
Locations: Madrigal Research Site, Dothan, Alabama, United States|Madrigal Research Site, Tucson, Arizona, United States|Madrigal Research Site, Coronado, California, United States|Madrigal Research Site, Los Angeles, California, United States|Madrigal Research Site, Rialto, California, United States|Madrigal Research Site, San Diego, California, United States|Madrigal Research Site, Ventura, California, United States|Madrigal Research Site, Englewood, Colorado, United States|Madrigal Research Site, Boca Raton, Florida, United States|Madrigal Research Site, Lakewood Ranch, Florida, United States|Madrigal Research Site, Lauderdale Lakes, Florida, United States|Madrigal Research Site, Miami, Florida, United States|Madrigal Research Site, New Port Richey, Florida, United States|Madrigal Research Site, Kansas City, Kansas, United States|Madrigal Research Site, Monroe, Louisiana, United States|Madrigal Research Site, Baltimore, Maryland, United States|Madrigal Research Site, Jackson, Mississippi, United States|Madrigal Research Site, Saint Louis, Missouri, United States|Madrigal Research Site, Albuquerque, New Mexico, United States|Madrigal Research Site, New York, New York, United States|Madrigal Research Site, Durham, North Carolina, United States|Madrigal Research Site, Rapid City, South Dakota, United States|Madrigal Research Site, Live Oak, Texas, United States|Madrigal Research Site, San Antonio, Texas, United States|Madrigal Research Site, Charlottesville, Virginia, United States|Madrigal Research Site, Seattle, Washington, United States
URL: https://ClinicalTrials.gov/show/NCT02912260

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