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This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2070, 150 mg | Experimental |
| |
| SYH2070, 150 mg placebo | Placebo Comparator |
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| SYH2070, 300 mg | Experimental |
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| SYH2070, 300 mg placebo | Placebo Comparator |
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| SYH2070, 400 mg | Experimental |
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| SYH2070, 400 mg placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2070 | Drug | SYH2070 injection, 150 mg, 300 mg, 400 mg, SC, administration duration: 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in serum TG levels from baseline at week 24 | Baseline through Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
1) Alanine aminotransferase or aspartate aminotransferase or γ-glutamyl transferase exceeds 2.0 times the upper limit of normal (ULN), or total bilirubin exceeds 1.5 times of the ULN; 2) QTcF interval: for males, > 450 ms; for females, > 470 ms; 3) HBsAg positive and HBV-DNA positive; or HCV antibody positive and HCV RNA positive; or positive for HIV antibody or anti- Treponema pallidum antibody; 4) Creatine kinase exceeds 3 times of the ULN; 5) Thyroid stimulating hormone is lower than the lower limit of normal or exceeds 1.5 times of the ULN (except for those who have been using thyroid hormone replacement therapy for 12 weeks or more before LDL-C testing in the screening period); 6) eGFR < 30 mL/min/1.73m2 (calculated using the MDRD formula); 24. General criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Placebo | Drug | Placebo, SC, administration duration: 24 weeks |
|
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |