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The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1918 Injection Group | Experimental | SHR-1918 injection. |
|
| SHR-1918 Injection Placebo Group | Placebo Comparator | SHR-1918 injection placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1918 Injection | Drug | SHR-1918 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in triglyceride (TG) relative to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miaomiao Shi | Contact | +86-0518-82342973 | miaomiao.shi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
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| SHR-1918 Injection Placebo |
| Drug |
SHR-1918 injection placebo. |
|
Phase 2.
| At 12 weeks of treatment. |
| Percentage change in total cholesterol (TC) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in apolipoprotein B (ApoB) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in Apolipoprotein A1 (ApoA1) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in triglyceride (TG) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in total cholesterol (TC) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in apolipoprotein B (ApoB) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in Apolipoprotein A1 (ApoA1) relative to baseline. | Phase 2. | AT 12 weeks of treatment. |
| Change in Lipoprotein(a) (Lp(a)) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in Lipoprotein(a) (Lp(a)) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Change in high-density lipoprotein cholesterol (HDL-C) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in high-density lipoprotein cholesterol (HDL-C) relative to baseline. | Phase 2. | At 12 weeks of treatment. |
| Proportion of subjects with the overall LDL-C achievement rate. | Phase 2. | At 12 weeks of treatment. |
| Proportion of subjects with the LDL-C achievement rates in different risk groups. | Phase 2. | At 12 weeks of treatment. |
| Change in LDL-C decreased by ≥ 50% to baseline. | Phase 2. | At 12 weeks of treatment. |
| Percentage change in LDL-C decreased by ≥ 50% to baseline. | Phase 2. | At 12 weeks of treatment. |
| Incidence and severity of adverse events (AEs). | Phase 2. | Approximately 12 weeks. |
| Incidence and severity of injection site reactions. | Phase 2. | Approximately 12 weeks. |
| Percentage change in non-HDL-C relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in TG relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in TC relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in ApoB relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in ApoA1 relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in TG relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in non-HDL-C relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in TC relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in ApoB relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in ApoA1 relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in Lp(a) relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in Lp(a) relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Change in HDL-C relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in HDL-C relative to baseline. | Phase 3. | At 24 weeks of treatment. |
| Proportion of subjects with the overall LDL-C achievement rate. | Phase 3. | At 24 weeks of treatment. |
| Proportion of subjects with the LDL-C achievement rates in different risk groups. | Phase 3. | At 24 weeks of treatment. |
| Change in LDL-C decreased by ≥ 50% to baseline. | Phase 3. | At 24 weeks of treatment. |
| Percentage change in LDL-C decreased by ≥ 50% to baseline. | Phase 3. | At 24 weeks of treatment. |
| Incidence and severity of adverse events (AEs). | Phase 3. | Approximately 24 weeks. |
| Incidence and severity of injection site reactions. | Phase 3. | Approximately 24 weeks. |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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