Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Group 2:CREPT-618, Dosage of 1.5mg/kg
Group 1:CREPT-618, Administer at a dosage of 2.0mg/kg or 2.5mg/kg
Sponsors
Tianjin Fifth Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years (inclusive), regardless of gender. 2. According to the Guidelines for the Prevention and Treatment of Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) issued by the Chinese Society of Hepatology, Chinese Medical Association, patients with MASH should meet the diagnostic criteria for MAFLD. 3. In addition to meeting the diagnostic criteria for MAFLD, participants should also meet at least one of the following two criteria: (1) If previous liver biopsy results are available (within 6 months prior to enrollment), the following conditions must be met: NAS >= 4 with a score of at least 1 for steatosis, at least 1 for ballooning, and at least 1 for lobular inflammation, and fibrosis stage between F0 and F3 (inclusive); (2) In the absence of previous liver biopsy results, a presumptive diagnosis of MASH can be made if the following conditions are met: VCTE-LSM > 5.5 kPa; CAP >= 280 dB/m. 4. MRI-PDFF >= 8% during screening (previous test results obtained within 8 weeks prior to enrollment are acceptable). 5. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe comorbidities or laboratory abnormalities: a. ALT or AST >= 5 × ULN; b. Total bilirubin (Tbil) >= 2 × ULN; c. Platelet count (PLT) 1.3; f. Serum creatinine (Cr) >= 1.5 × ULN or creatinine clearance rate = 4 weeks within the 24 weeks prior to enrollment, or planned use during the study period, of any of the following drugs that may induce steatosis/steatohepatitis: including amiodarone, methotrexate, systemic corticosteroids (at a dose > 5 mg/day of prednisone equivalent), estrogens (at doses exceeding those used for hormone replacement therapy or contraception), tetracyclines, tamoxifen, anabolic steroids, valproic acid, or other known hepatotoxic drugs. 3. Currently receiving treatment with glucagon-like peptide-1 receptor agonists (GLP-1), pioglitazone, or vitamin E at a daily dose > 400 IU (unless the medication has been used at a stable dose for at least 24 weeks prior to enrollment and the regimen is maintained unchanged during the study period). 4. Currently receiving lipid-lowering therapy, such as statins (atorvastatin, rosuvastatin, simvastatin, etc.), cholesterol absorption inhibitors (ezetimibe), PCSK9 inhibitors, etc. (unless the medication has been used at a stable dose for at least 24 weeks prior to enrollment and the regimen is maintained unchanged during the study period). 5. Individuals with known concurrent hepatobiliary diseases, including but not limited to: active hepatitis B virus or active hepatitis C virus infection, primary sclerosing cholangitis, complete biliary obstruction, acute cholecystitis or cholelithiasis with significant symptoms (e.g., biliary colic), drug-induced liver injury, hemochromatosis, refractory or diuretic-resistant ascites, suspected or confirmed primary liver cancer, cholangiocarcinoma. 6. Individuals who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) [requiring further confirmation by hepatitis C virus RNA (HCV RNA) testing (values above the lower limit of detection of the assay should be excluded)], human immunodeficiency virus antibodies (HIV Ab), or treponema pallidum antibodies (TPAb) at screening. 7. A history of arrhythmias requiring clinical intervention that may potentially impact survival during the study period; or those with a QTcF interval >= 450 ms for males or >= 470 ms for females at screening (Fridericia's correction formula); or individuals expected to use QT interval-prolonging medications during the study period. 8. Individuals who have undergone gastric bypass surgery. 9. Individuals who have used moderate or strong inhibitors or inducers of CYP3A4 within 14 days prior to signing the informed consent form or during the entire study period. (Strong inducers mainly include rifampicin, carbamazepine, phenytoin, phenobarbital, etc.; moderate inducers mainly include bosentan, dexamethasone, rifapentine, etc.; strong inhibitors mainly include ketoconazole, itraconazole, posaconazole, voriconazole, indinavir, clarithromycin, etc.; moderate inhibitors mainly include fluconazole, verapamil, diltiazem, erythromycin, Schisandra chinensis, dronedarone, cyclosporine, amiodarone, cimetidine, imatinib, etc.); 10. A history of malignancy within 5 years prior to signing the informed consent form (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in MRI-PDFF score;Frequency and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity;Pharmacokinetics of multiple doses;Preliminary efficacy;Pharmacokinetics of single dose; | — |
Countries
China
Contacts
Public ContactWenhan Wu
Tianjin Fifth Central Hospital
Outcome results
None listed