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A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH

NCT07581951 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-12

No results posted yet for this study

Summary

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.

Conditions

  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • NASH (Non-Alcoholic Steatohepatitis)

Interventions

DRUG

HSK31679

tablet

DRUG

Placebo

Matching tablet

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2029-08-30

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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 NCT07581951 on ClinicalTrials.gov