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The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1209 | Experimental |
| |
| SHR-1209 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1209 | Drug | SHR-1209 |
| |
| SHR-1209 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 12-weeks or 16weeks Percentage change in LDL-C relative to baseline | 12-weeks or 16weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 12-weeks or 16weeks change in LDL-C relative to baselineï¼› | 12-weeks or 16weeks | |
| Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment | 12 weeks or 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangzhou | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40587053 | Derived | Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30. |
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| ID | Term |
|---|---|
| D006954 | Hyperlipoproteinemia Type V |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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SHR-1209 monotherapy
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| Drug |
SHR-1209 Placebo |
|
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015228 | Hypertriglyceridemia |