This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).
Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.
Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.
Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or
VCTE measured liver stiffness 8.0 kPa ≤ LSM < 20.0 kPa, CAP>302 dB/m.
Currently or prior history of hepatocellular carcinoma.
Previous or planned liver transplant.
History or evidence of any acute or chronic liver disease other than MASH.
Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).
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Treatment groupsSee each treatment group below.