Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).
This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 (150 mg, 300 mg, and 450 mg) and placebo in approximately 204 subjects with NASH. Subjects will be screened over a 49-day period to determine their eligibility based on specific history, physical, laboratory, and imaging evaluations, which will require more than one visit during the screening period. On Day 1, subjects will be randomized 2:1:2:2 into 1 of 4 treatment groups (placebo, 150 mg HU6, 300 mg HU6, or 450 mg HU6). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, PD, and PK during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30). ;
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