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NCT Number: NCT07620366

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

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).

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Key information

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    Time frame: Baseline to Week 24

    Change from baseline in hepatic fat fraction, measured by MRI-PDFF

Study contacts

Contact information is provided by the study sponsor or research team.

Dandan Guo, Master

CONTACT

[email protected]

+86-0531-55821372

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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).

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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