Metabolic Dysfunction-associated Steatohepatitis (MASH)
Conditions
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).
Interventions
DRUGQL2401 25 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.
DRUGQL2401 50 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.
DRUGQL2401 100 mg
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.
DRUGQL2401 placebo 25 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
DRUGQL2401 placebo 50 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
DRUGQL2401 placebo 100 mg
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 24 relative to baseline | Baseline to Week 24 | Change from baseline in hepatic fat fraction, measured by MRI-PDFF |
Contacts
CONTACTDandan Guo, Master
Outcome results
None listed