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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2401 25 mg | Experimental |
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| QL2401 50 mg | Experimental |
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| QL2401 100 mg | Experimental |
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| QL2401 placebo 25 mg | Placebo Comparator |
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| QL2401 placebo 50 mg | Placebo Comparator |
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| QL2401 placebo 100 mg | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
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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:
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:
Other inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Guo, Master | Contact | +86-0531-55821372 | dandan1.guo@qilu-pharma.com |
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| 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. |
|