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NOT YET RECRUITING
NCT07620366
PHASE2

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.

View on ClinicalTrials.gov

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

DRUG

QL2401 25 mg

QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.

DRUG

QL2401 50 mg

QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.

DRUG

QL2401 100 mg

QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.

DRUG

QL2401 placebo 25 mg

Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.

DRUG

QL2401 placebo 50 mg

Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.

DRUG

QL2401 placebo 100 mg

Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.