NCT05462353

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH

A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Gannex Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).

Conditions

• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	2mg of ASC41	ASC41 tablet administered orally once daily.
DRUG	4mg of ASC41 (2 tablets of 2 mg ASC41)	ASC41 tablets administered orally once daily.
DRUG	Placebo	Placebo tablets administered orally once daily.

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-05-10
• Completion: 2025-06-10
• First posted: 2022-07-18
• Last updated: 2025-01-08

Locations

1 site across 1 country: China