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The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection; | Experimental |
| |
| SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection; | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1918/ SHR-1918 placebo | Drug | SHR-1918/ SHR-1918 placebo Dose 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline | at 20 weeks and 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in non-HDL-C relative to baseline | at 24 weeks of treatment | |
| Percentage change in LDL-C relative to baseline | at 24 weeks of treatment | |
| Percentage change in TC relative to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miaomiao Shi | Contact | 18036617171 | Miaomiao.shi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| SHR-1918/ SHR-1918 placebo | Drug | SHR-1918/ SHR-1918 placebo Dose 2 |
|
| at 24 weeks of treatment |
| Percentage change in ApoB relative to baseline | at 24 weeks of treatment |
| Percentage change in ApoA1 relative to baseline | at 24 weeks of treatment |
| Change in TG relative to baseline | at 24 weeks of treatment |
| Change in non-HDL-C relative to baseline | at 24 weeks of treatment |
| Change in LDL-C relative to baseline | at 24 weeks of treatment |
| Change in TC relative to baseline | at 24 weeks of treatment |
| Change in ApoB relative to baseline | at 24 weeks of treatment |
| Change in ApoA1 relative to baseline | at 24 weeks of treatment |
| Change and percentage change in Lp(a) relative to baseline | at 24 weeks of treatment |
| Change and percentage change in HDL-C relative to baseline | at 24 weeks of treatment |
| Proportion of subjects with TG < 1.7 mmol/L | at 24 weeks and 48 weeks of treatment |
| Change and percentage change in non-HDL-C relative to baseline | at 48 weeks of treatment |
| Change and percentage change in LDL-C relative to baseline | at 48 weeks of treatment |
| Change and percentage change in TC relative to baseline | at 48 weeks of treatment |
| Change and percentage change in ApoB relative to baseline | at 48 weeks of treatment |
| Change and percentage change in ApoA1 relative to baseline | at 48 weeks of treatment |
| Change and percentage change in Lp(a) relative to baseline | at 48 weeks of treatment |
| Change and percentage change in HDL-C relative to baseline | at 48 weeks of treatment |
| Change and percentage change in TG relative to baseline | at 48 weeks of treatment |
| Proportion of subjects who received rescue treatment | Approximately a year |
| Incidence and severity of adverse events and injection site reactions | Approximately a year |
| D009750 |
| Nutritional and Metabolic Diseases |