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To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3)
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
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).
Official title: 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).
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-06
Completion Date
2028-03
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
QL2401 25 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.
QL2401 50 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.
QL2401 100 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.
QL2401 placebo 25 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
QL2401 placebo 50 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
QL2401 placebo 100 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.