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The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1918 low dose | Experimental |
| |
| SHR-1918 placebo low dose | Placebo Comparator |
| |
| SHR-1918 high dose | Experimental |
| |
| SHR-1918 placebo high dose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1918 | Drug | SHR-1918 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change of serum LDL-C from baseline; | Baseline and Week 24 | |
| The percentage change in serum TG from baseline; | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline; | Baseline and Week 24 | |
| The percentage change in serum total cholesterol (TC) from baseline; | Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Qi | Contact | +86 0518 82342973 | Sheng.qi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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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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| SHR-1918 placebo |
| Drug |
SHR-1918 placebo |
|
| The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24; | Baseline and Week 24 |
| The percentage change of serum apolipoprotein A1 (ApoA1) from baseline; | Baseline and Week 24 |
| The change from baseline in serum LDL-C; | Baseline and Week 24 |
| The change from baseline in serum TG; | Baseline and Week 24 |
| The change from baseline in serum non-HDL-C; | Baseline and Week 24 |
| The change from baseline in serum TC; | Baseline and Week 24 |
| The change from baseline in serum ApoB; | Baseline and Week 24 |
| The change from baseline in serum ApoA1; | Baseline and Week 24 |
| Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a)); | Baseline and Week 24 |
| Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C); | Baseline and Week 24 |
| LDL-C goal attainment rates at Week 24, overall and by risk subgroup; | Baseline and Week 24 |
| Absolute and percentage change from baseline in serum non-HDL-C at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum ApoB at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum Lp(a) at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum TC at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum TG at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum HDL-C at Week 48; | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum ApoA1 at Week 48; | Baseline and Week 48 |
| LDL-C goal attainment rates at Week 48, overall and by risk subgroup | Baseline and Week 48 |
| The incidence and severity of adverse events (AEs) throughout the study; | up to week 52 |
| Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study; | up to week 52 |
| Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study; | up to week 52 |