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Not yet recruiting NCT07620366

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

Phase II Interventional Metabolic Dysfunction-associated Steatohepatitis (MASH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL2401 25 mg, QL2401 50 mg, QL2401 100 mg, QL2401 placebo 25 mg.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Overview

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).

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.

Primary outcome measures

  • Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 24 relative to baseline [Time frame: Baseline to Week 24]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.
  • Hepatic fat fraction > 10% measured by MRI-PDFF at screening or within 3 months.
  • Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.
  • Participants maintain a stable body weight (±5%) within 2 months prior screening.

Exclusion criteria

  • 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).

Other inclusion and exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07620366 · QL2401-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗