A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Time frame: Baseline to Week 48
Number of Participants With Treatment-Related Adverse Events (AE)
Time frame is 52 weeks unless an unresolved AE is still being followed
Time frame: 52 Weeks
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Adobe Clinical Research, LLC
Tucson, Arizona, United States
Arizona Liver Health
Tucson, Arizona, United States
Arcare Center for Clinical Research
Little Rock, Arkansas, United States
Clinical Trials Research
Lincoln, California, United States
United Clinical Research Institute
Los Alamitos, California, United States
Velocity Clinical Research
Los Angeles, California, United States
Alliance Clinical Research
Poway, California, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, United States
Miami Clinical Research
Miami, Florida, United States
...and 67 more locations