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This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
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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 Percentage change in serum LDL-C levels from baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 12 weeks Absolute Changes in serum LDL-C levels from baselineï¼› | 12 weeks | |
| 12 weeks Percentage change of non-HDL-C relative to baselineï¼› | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
A history of the following diseases or treatments during the screening period:
Any of the laboratory test indicators meets the following criteria:
Have used the following drugs:
Other circumstances:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangzhou | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40911402 | Derived | Li L, Zhou Y, Deng C, Sheng J, Peng D, Ling Z, Wang L, Dai C, Huang K, Lian Q, Yu Z, Yang H, Hu Y, Dong Y, Wang N, Wang Z, Zhang W, Han X, Yao Z, Liu Q, Liang Y, Xu B, Wang Y, Zhong T, Chen J. Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study. Cardiovasc Res. 2025 Oct 24;121(12):1856-1864. doi: 10.1093/cvr/cvaf155. | |
| 40587053 |
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Background Lipolowering therapy in combination with SHR-1209/ placebo
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| Drug |
SHR-1209 Placebo |
|
| 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. |