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

Haisco Pharmaceutical Group

Status and phase

Begins enrollment in 1 month

Phase 3

Conditions

NASH (Non-Alcoholic Steatohepatitis)

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Treatments

Drug: HSK31679

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07581951

HSK31679-301

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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% ,Liver Stiffness Measurement (LSM) ≥ 8.5 kPa and Controlled Attenuation Parameter (CAP) ≥ 280 dB/m measured by FibroScan obtained during the screening period.
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.

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.