At a glance
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A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)
In Brief
A Phase 2 clinical trial evaluating TVB-2640 25 mg (US), TVB-2640 50 mg (US), and 4 other interventions for MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis). Completed, enrolled 142 participants across 23 sites in 2 countries.
Detailed Summary
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 Details
Timeline
Interventions
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing