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The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
This trial plans to enroll 900 Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2053 injection | Experimental | Participants in this cohort receive three doses |
|
| SYH2053 injection placebo | Placebo Comparator | Participants in this cohort receive three doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2053/placebo injection | Drug | Participants receive SYH2053/placebo injection by subcutaneous administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C relative to baseline | Day 330 |
| Measure | Description | Time Frame |
|---|---|---|
| The value of change in LDL-C relative to baseline | Day 330 | |
| Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels | Day 90-360 | |
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Inclusion Criteria:
With a history of ASCVD:
Very high risk: 55 mg/dL (1.4 mmol/L) ≤ LDL-C < 188 mg/dL (4.9 mmol/L);
Extremely high risk: LDL-C ≥ 70 mg/dL (1.8 mmol/L);
Without a history of ASCVD:
Moderate to high risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L);
Low risk: LDL-C ≥ 130 mg/dL (3.4 mmol/L); 4.Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 0311-69085587 | ctr-contact@cspc.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliation: Peking University Third Hospital | Beijing | Beijing Municipality | China |
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| Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description: |
| Days 1-360 |
| Number of ADA and Nab | Day 30-360 |
| 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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