Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
brief summary
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
detailed description
Clinical trial DA1241\_NASH\_IIa is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with presumed NAFLD.
Part 1 of this clinical trial intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 at varying doses or identical placebo in 3 treatment groups for 16 weeks/112 days.
Part 2 intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 in combination with sitagliptin versus an identical placebo for 16 weeks/112 days.
official title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)