NCT06168383

To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .

A Multicenter, Double-blind, Placebo Randomized , Phase2b Study to Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis.

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	HSK31679 80mg	once daily, oral administration of HSK31679 80mg from Day 1 to Week 52.
DRUG	HSK31679 160mg	once daily, oral administration of HSK31679 160mg from Day 1 to Week 52.
DRUG	Placebo	once daily, oral administration of placebo from Day 1 to Week 52.

Timeline

• Start date: 2024-01-05
• Primary completion: 2025-12-12
• Completion: 2026-01-16
• First posted: 2023-12-13
• Last updated: 2026-02-11

Locations

1 site across 1 country: China