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Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH

NON-ALCOHOLIC STEATOHEPATITIS Clinical Trial

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)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06054815
Study type Interventional
Source NeuroBo Pharmaceuticals Inc.
Contact Robert Homolka
Phone (917) 633-6086
Email CRInfo@neurobopharma.com
Status Recruiting
Phase Phase 2
Start date September 14, 2023
Completion date December 2024
View Details
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