This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
ProSciento
Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline
As determined by MRI-PDFF
Time frame: 12 weeks
Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12.
As determined by MRI-PDFF
Time frame: 12 weeks
Percentage of Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: 12 weeks
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Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
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Austin, Texas, United States
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...and 13 more locations