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

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).

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
• Intervention / Treatment: Drug: QL2401 25 mg; Drug: QL2401 50 mg; Drug: QL2401 100 mg; Drug: QL2401 placebo 25 mg; Drug: QL2401 placebo 50 mg; Drug: QL2401 placebo 100 mg

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dandan Guo, Master; Phone Number: +86-0531-55821372; Email: dandan1.guo@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females between 18 - 75 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 or within 3 months.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL2401 25 mg	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.
Experimental: QL2401 50 mg	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.
Experimental: QL2401 100 mg	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.
Placebo Comparator: QL2401 placebo 25 mg	Drug: QL2401 placebo 25 mg; Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
Placebo Comparator: QL2401 placebo 50 mg	Drug: QL2401 placebo 50 mg; Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
Placebo Comparator: QL2401 placebo 100 mg	Drug: QL2401 placebo 100 mg; Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QL2401-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No