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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.
Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 24 relative to baseline
Change from baseline in hepatic fat fraction, measured by MRI-PDFF
Time frame: Baseline to Week 24
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Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.