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New pill could stop liver scarring in MASH patients

NCT ID NCT07581951

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the drug HSK31679 can safely improve liver health in 400 adults with MASH, a serious fatty liver disease. Participants will take either the drug or a placebo daily for about a year. The main goals are to see if the drug can reverse liver inflammation and scarring without making the disease worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK31679 (a tablet drug)
What this could lead to
If it works, this could lead to a new treatment that reverses liver inflammation and scarring in people with MASH, potentially preventing liver failure.
What could go wrong
This is a large Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results won't be available for several years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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