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The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2068 Dose 1 | Experimental |
| |
| SYH2068 Dose 2 | Experimental |
| |
| SYH2068 Dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2068 Dose 1 | Drug | Administered by subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Lp(a) from baseline to Day 60~180 | Day 60~180 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Lp(a) from baseline to Day 30~540 | Day 30~540 | |
| The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L. | Day 30~540 | |
| Changes of LDL-C from baseline to Day 30~540 |
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Inclusion Criteria:
Exclusion 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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| SYH2068 Dose 2 |
| Drug |
Administered by subcutaneous injection. |
|
| SYH2068 Dose 3 | Drug | Administered by subcutaneous injection. |
|
| Placebo | Drug | Administered by subcutaneous injection. |
|
| Day 30~540 |
| Changes of ApoB from baseline to Day 30~540 | Day 30~540 |
| Incidence of TEAEs during the treatment | During treatment |
| ADA incidence | During treatment |
| The plasma concentration of SYH2068. | During treatment |