NCT06054815

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NON-ALCOHOLIC STEATOHEPATITIS

Interventions

Type	Name	Description
DRUG	DA-1241	Route of Administration: Oral, with subjects in a fasting state
DRUG	Sitagliptin	Route of Administration: Oral, with subjects in a fasting state
DRUG	DA-1241 Placebo	Route of Administration: Oral, with subjects in a fasting state
DRUG	Sitagliptin Placebo	Route of Administration: Oral, with subjects in a fasting state

Timeline

• Start date: 2023-09-14
• Primary completion: 2024-10-24
• Completion: 2024-10-30
• First posted: 2023-09-26
• Last updated: 2024-11-14

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study