MASH - Metabolic Dysfunction-Associated SteatohepatitisPhase 3NCT07581951
A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
A Phase 3 study testing HSK31679 in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and NASH (Non-Alcoholic Steatohepatitis), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
- What is being tested?
- HSK31679
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 886 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 010
Lai Wei, 86+010-56112345, weelai@163.com
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)
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) .
Read the detailed description
This study has 2 parts.Participants will be assigned to Part 1 based on screening histologic (liver biopsy) criteria or non-invasive test criteria. The purpose of the first part of this study is to find out the effect of HSK31679 on MASH and liver fibrosis. Participants will be assigned to Part 2 based on non-invasive test criteria.The purpose of the second part is to find out how safe HSK31679 is in improving liver function.
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
- Being tested
- HSK31679, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31679Drug
tablet
PlaceboDrug
Matching tablet
| Study group | Role | What they receive |
|---|---|---|
| HSK31679 dose | Experimental | HSK31679 tablet, orally, once daily Receives: Drug: HSK31679 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Measured: Week 52
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.
Measured: Week 52
Time to First Occurrence of Disease Progression
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
Measured: Up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASH - Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 886 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581951
- Sponsor's protocol ID
- HSK31679-301
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT07581951
- Acronym / sponsor ID
- HSK31679-301
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 886 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Detailed description
This study has 2 parts.Participants will be assigned to Part 1 based on screening histologic (liver biopsy) criteria or non-invasive test criteria. The purpose of the first part of this study is to find out the effect of HSK31679 on MASH and liver fibrosis. Participants will be assigned to Part 2 based on non-invasive test criteria.The purpose of the second part is to find out how safe HSK31679 is in improving liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK31679 dose | Experimental | Drug: HSK31679HSK31679 tablet, orally, once daily |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK31679tablet | Drug | HSK31679 dose |
| PlaceboMatching tablet | Drug | Placebo |
Primary outcome
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.
Time frame: Week 52
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.
Time frame: Week 52
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.
Time to First Occurrence of Disease Progression
Time frame: Up to 4.5 years
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK31679 in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and NASH (Non-Alcoholic Steatohepatitis), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fangqiong li (028-67258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52. (time frame: Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.