Status:
ACTIVE_NOT_RECRUITING
To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Non-Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With N...
Eligibility Criteria
Inclusion
- Must be willing to participate in the study and provide written informed consent.
- Male or female aged 18 ≤ age \< 65 at the time of signing the informed consent
- Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 2 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
- Must have confirmation of ≥8% liver fat content on MRI-PDFF.
- Weight changes≤5% in the 6 weeks prior to randomization.If a historical biopsy is to be used, patients must have had weight changed≤5%, too.
Exclusion
- History or presence of cirrhosis，hepatic decompensation or impairment defined as presence of any of the following: history of esophageal varices, ascites, or hepatic encephalopathy, or hepatocellular carcinoma.
- Use of high dose vitamin E (\>400 IU/day)，polyunsaturated fatty acid or ursodeoxycholic acid unless stable for ≥6 months prior to an eligible screening liver biopsy. Use of thiazolidinediones, sodium-glucose co-transporter 2 inhibitors or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) unless stable for ≥3 months prior to an eligible screening liver biopsy.
- Use of Glucagon-like peptide 1 \[GLP-1\] agonist therapy (e.g.,liraglutide, semaglutide, dulaglutide and exenatide ) within 6 months prior to an eligible screening liver biopsy.
- Use of drugs that have the potential to affect thyroid hormone production and/or interfere with thyroid function.
- Potent inhibitors of CYP2C8 such as gemfibrozil and trimethoprim are prohibited. An inducer of CYP2C8, rifampicin, is prohibited.
- Use of drugs historically associated with NAFLD/NASH for 2 weeks prior to an eligible screening liver biopsy, which include, but are not limited, to the following: total parenteral nutritionamiodarone, methotrexate, systemic glucocorticoids (if use within 3 months prior to a biopsy is also not permitted), tamoxifen, tetracycline, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids , valproic acid, and known hepatotoxins.
- Regular use of drugs historically associated with NAFLD/NASH within 12 months prior to liver biopsy (including historical biopsy), which include, but are not limited, to the following:PPAR agonists (e.g. lanifibranor, Siglitazone sodium) ，FXR agonists (e.g., obecholic acid, HTD1801)，FGF21 analogs (e.g., AP025, efruxifermin , pegozafermin(B1089-1001)) ; DGAT2 inhibitors (e.g., PF 6865571 and ION224),PDE inhibitors (e.g., ZSP1601) and other thyroid hormone receptor B agonists \[e.g.,resmetirom（MGL-3196）、ASC41 and VK2809).
- Lipid-lowering therapy that did not meet the following criteria: fenofibrate, ezetimibe stable for at least 3 months before randomization and remained unchanged during study treatment, and statins stable for at least 4 weeks before randomization and remained unchanged during study treatment.
- Type 1 diabetes or uncontrolled Type 2 diabetes defined as:
- Hemoglobin A1c \>9.5% at screening (patients with HbA1c \>9.5% may be rescreened),
- Insulin dose adjustment \>20% within 60 days prior to enrollment,
- Requirement for glucagon-like peptide analogue (unless on a stable dose ≥ 6 months prior to screening) or History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status).
- Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \>160 mmHg or a diastolic blood pressure \>100 mmHg at screening.
- Evidence of other forms of chronic liver disease including the following:biliary bypass, drug induced liver disease, alcoholic liver disease, autoimmune hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hemohemosis, Wilson's disease, α-1 antitrypsin deficiency, bile duct obstruction, primary or metastatic liver cancer, hepatitis B, or present Hepatitis virus (HCV) infection.
- Thyroid diseases: hyperthyroidism and hypothyroidism. Thyroid peroxidase antibodies (TPOAb) or thyroglobulin antibodies (TGAb) that have been determined by the investigators to be clinically significant.
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months prior to screening.
- New York Heart Association class III or IV heart failure, or known left ventricular ejection fraction \<30%.
- Serum ALT or AST \>5 × ULN; Serum ALP≥2× ULN；eGFR\<60 mL/min/1.73m2；INR\>1.5× ULN；platelets \< 80×109/L.
- Participation in an investigational new drug trial in the 90 days prior to randomization.
- Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06168383
Start Date
November 23 2023
End Date
April 1 2026
Last Update
February 19 2025
Active Locations (1)
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1
Beijing Tsinghua Changgung Hospital, Tsinghua University
Beijing, China