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COMPLETED
NCT06168383
PHASE2

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-01-05

Completion Date

2026-01-16

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing Tsinghua Changgung Hospital, Tsinghua University

Beijing, China