MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
Conditions
Brief 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) .
Interventions
DRUGHSK31679
tablet
DRUGPlacebo
Matching tablet
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52. | 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. | 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 | 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 |
Contacts
CONTACTfangqiong li
Outcome results
None listed