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

NCT07620366 — Phase 2, Not yet recruiting, 132 participants, Qilu Pharmaceutical Co., Ltd.

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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 (MASH) and Liver Fibrosis

Registry	NCT07620366
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	132 (Estimated)
Sponsor	Qilu Pharmaceutical Co., Ltd. (Industry)
Conditions	Metabolic Dysfunction-associated Steatohepatitis (MASH)
Interventions	QL2401 25 mg, QL2401 50 mg, QL2401 100 mg, QL2401 placebo 25 mg, QL2401 placebo 50 mg, QL2401 placebo 100 mg (Drug)
Dates	start 2026-12-01 (estimated), primary completion 2027-06-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-06-02, last updated 2026-10-22

-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).

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+Arms and interventions

Arm	Type	Interventions
QL2401 25 mg	Experimental	Drug: QL2401 25 mg
QL2401 50 mg	Experimental	Drug: QL2401 50 mg
QL2401 100 mg	Experimental	Drug: QL2401 100 mg
QL2401 placebo 25 mg	Placebo comparator	Drug: QL2401 placebo 25 mg
QL2401 placebo 50 mg	Placebo comparator	Drug: QL2401 placebo 50 mg
QL2401 placebo 100 mg	Placebo comparator	Drug: QL2401 placebo 100 mg

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.

+Outcome measures

Primary outcomes

Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 12 relative to baseline [Baseline to Week 12]: Change from baseline in hepatic fat fraction, measured by MRI-PDFF

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Males and females between 18 - 80 years of age inclusive, based on the date of signation of ICF.
2. Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.
3. 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.
4. Hepatic fat fraction > 10% measured by MRI-PDFF at screening.
5. Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.
6. Participants maintain a stable body weight (±5%) within 2 months prior screening.

Exclusion Criteria:

1. Currently or prior history of hepatocellular carcinoma.
2. Previous or planned liver transplant.
3. History or evidence of any acute or chronic liver disease other than MASH.
4. Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).

Other inclusion and exclusion criteria may apply.