HSK31679 in MASH: a phase 3 test for safety and liver improvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 3 study evaluating the safety and tolerability and potential liver benefits of HSK31679 in adults with metabolic dysfunction-associated steatohepatitis (MASH). The study has two parts: Part 1 uses liver biopsy or non-invasive criteria to assess the effect on liver fibrosis and disease activity, while Part 2 focuses on safety in improving liver function. Participants are assigned to receive either HSK31679 or placebo, with central laboratory confirmation of histology when available. Key eligibility includes adults with cardiometabolic risk factors, MRI-PDFF fat fraction ≥8%, and histologically confirmed MASH or a qualifying liver biopsy within 6 months. Exclusion criteria include significant recent alcohol use, high MELD score, or prior conflicting therapies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 1\. Must be willing to participate in the study and provide written informed consent.
* 2.Male and female adults ≥ 18 years of age.
* 3.Have at least one cardiometabolic risk factors at screening.
* 4.MRI-PDFF fat fraction ≥8%.
* 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \< F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.
* 6.Body weight fluctuation \< 5% for at least 6 weeks before randomization.

Key Exclusion Criteria:

* 1\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
* 2.MELD score ≥12 due to hepatic disease。
* 3.Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).
* 4.Participants who had not been on stable medication with vitamin E (dose\>400 IU/day) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).
* 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.
* 6.HbA1c ≥ 8.0%.
* 7.Chronic liver diseases other than NASH.
* 8.Active autoimmune disease. 9.Serum ALT \> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \< 2 years.

Where it's running

• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: fangqiong li
• Email: lifangq@haisco.com
• Phone: 028-67258840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.