To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3)

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3).

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).

Inclusion Criteria:

1. Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.

2. Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.

3. Any one criterion as follow:

   • 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.

4. Hepatic fat fraction > 10% measured by MRI-PDFF at screening or within 3 months.

5. Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.

6. Participants maintain a stable body weight (±5%) within 2 months prior screening.

Exclusion Criteria:

1. Currently or prior history of hepatocellular carcinoma.
2. Previous or planned liver transplant.
3. History or evidence of any acute or chronic liver disease other than MASH.
4. Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).

Other inclusion and exclusion criteria may apply.