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

NCT07620366 | Not Yet Recruiting Phase 2

• 1 other identifier: QL2401-201
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Metabolic Dysfunction-associated Steatohepatitis (MASH)

Outcome Measures

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

  Baseline to Week 24

Study Arms (6)

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

Interventions

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 25 mg

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 50 mg

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 100 mg

QL2401 placebo 25 mg DRUG

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

QL2401 placebo 25 mg

QL2401 placebo 50 mg DRUG

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

QL2401 placebo 50 mg

QL2401 placebo 100 mg DRUG

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

QL2401 placebo 100 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Dandan Guo, Master

CONTACT

+86-0531-55821372; dandan1.guo@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05