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This is a randomized, double-blind, placebo- controlled phaseâ… b/â…¡clinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1209 | Experimental | Participants received one of 6 dose levels of SHR-1209 administered as multiple subcutaneous doses. |
|
| Placebo | Placebo Comparator | Participants received matching placebo dose regimens by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1209 | Drug | Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C. | Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6 | |
| Primary safety end point:Number of subjects with adverse events. | Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to end of the dosing interval in LDL-C. | Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6 | |
| Percent change from baseline to day 85 in LDL-C. | Baseline to day 85 for all 6 groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital ,The Second Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 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. | |
| 35039035 | Derived | Xu M, Zhu X, Wu J, Zhang Y, Zhao D, Wang X, Ding Y, Cao Y, Li C, Hu W, Sheng J, Luo Z, Zheng Z, Hu J, Liu J, Zhou X, Shen A, Ding X, Zhang Y, Zhao Y, Li Y, Zhong S, An S, Zou J, Yan L. PCSK9 inhibitor recaticimab for hypercholesterolemia on stable statin dose: a randomized, double-blind, placebo-controlled phase 1b/2 study. BMC Med. 2022 Jan 18;20(1):13. doi: 10.1186/s12916-021-02208-w. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous |
|
| Absolute change from baseline to day 85 in LDL-C. | Baseline to day 85 for all 6 groups |
| Percent change in PCSK9. | Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5 |
| Absolute change in PCSK9. | Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5 |