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With no approved pharmacotherapy in the US and Europe. Investigational monotherapies have shown encouraging but limited efficacy in broad NASH populations. Combinations of agents with complementary mechanisms to address the multiple pathogenic drivers of the disease may have advantages. This is the first trial assessing safety and efficacy of TERN-501, a THR-β agonist, and TERN-101, a FXR agonist, combination in NASH patients. 140 eligible non-cirrhotic NASH patients will be randomized equally to one of the 7 arms, with a 12-week once daily treatment period and a 4-week follow-up period. The factorial design will allow evaluation of the potential additive effects of TERN-501+TERN-101 combination compared to each agent and to placebo using noninvasive biomarkers..
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