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The Phase 3 clinical trial will be a multicenter, double-blind, placebo-controlled two-part study to evaluate the safety and efficacy of tesamorelin in liver-biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis.
Oral presentation includes data on the mechanism of effect of tesamorelin in nonalcoholic fatty liver disease (NAFLD) will be given by Lindsay T Fourman at The Liver Meeting® 2020 of the American Association for the Study of Liver Diseases (AASLD).
In the study, the treatment arm evaluating 40 mg BID of rifaximin SSD IR plus standard of care therapy met its primary endpoint of time to resolution of OHE.