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This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1918 | Experimental |
| |
| SHR-1918 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1918 | Drug | SHR-1918 |
| |
| SHR-1918 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in calculated LDL-C from baseline to week 16 | from baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in calculated LDL-C from baseline to week 16 | from baseline to week 16 |
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Inclusion Criteria:
Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening:
Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks;
a) Fasting LDL-C ≥ 2.6 mmol/L.
Fasting triglycerides ≤ 5.6 mmol/L.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167414 | Derived | Xie X, Shi X, Zhang Y, Su S, Jiang C, Miao L, Wang J, Peng D, Lv L, Chai X, Luo S, Zheng Y, Huang S, Zhu D, Liao S, Ren M, Gao X, Yang H, Zhou H, He Y, Han Y, Xu J, Zhang L, Du L, Yao Z, Sheng J, Peng X, Chen X, Li J, Mi J, Lu Q, Wang H, Shen Z, Zhao Z, Gao F, Lv C, Zhu M, Zhu Y, Wang J. Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia: A Phase 2 Study. J Am Coll Cardiol. 2025 May 20;85(19):1821-1835. doi: 10.1016/j.jacc.2025.03.008. Epub 2025 Mar 31. |
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
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| Drug |
SHR-1918 placebo |
|