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

ConditionMetabolic Dysfunction-associated Steatohepatitis (MASH)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • QL2401 25 mg

    Drug

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

  • QL2401 50 mg

    Drug

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

  • QL2401 100 mg

    Drug

    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

    Drug

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

  • QL2401 placebo 50 mg

    Drug

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

  • QL2401 placebo 100 mg

    Drug

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

Treatment groups

132 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: QL2401 25 mgExperimental treatment 1 intervention
Group B: QL2401 50 mgExperimental treatment 1 intervention
Group C: QL2401 100 mgExperimental treatment 1 intervention
Group D: QL2401 placebo 25 mgPlacebo comparator 1 intervention
Group E: QL2401 placebo 50 mgPlacebo comparator 1 intervention
Group F: QL2401 placebo 100 mgPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: