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

NCT06168383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-02-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2025-12-12
Completion
2026-01-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168383 on ClinicalTrials.gov