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To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLC7401 Injection | Experimental | Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule. |
|
| Placebo | Placebo Comparator | Participants receive placebo via subcutaneous injection according to the study schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLC7401 | Drug | QLC7401 combined with lipid-lowering agents |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C) | From baseline to Day 330 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C | Day 90 to Day 360 | |
| Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline | From baseline to Day 360 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian an Wang, Doctorate | Contact | 086-15990086511 | wang_jian_an@vip.tom.com |
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| Placebo |
| Drug |
Placebo combined with lipid-lowering agents |
|
| Incidence of Treatment-Emergent Adverse Events (TEAEs | Throughout the study duration] |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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