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The main purpose of this study is to evaluate the efficacy and safety of HRS-5632 in adult participants with elevated Lipoprotein(a) (Lp(a)) at high risk for cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5632 Dose 1 Group | Experimental |
| |
| HRS-5632 Dose 2 Group | Experimental |
| |
| HRS-5632 Dose 3 Group | Experimental |
| |
| HRS-5632 Dose 4 Group | Experimental |
| |
| HRS-5632 Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5632 Injection | Drug | HRS-5632 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percent change from the baseline in Lipoprotein (a) (Lp(a)). | From baseline to Day 360. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of all reported adverse events (AEs). | From Day 1 to Day 540. | |
| The percentage of all reported serious adverse events (SAEs). | From Day 1 to Day 540. | |
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Inclusion Criteria:
Understanding the specific procedures of the trial, voluntarily participating in this trial, and providing written informed consent;
Being at least 18 years of age on the day of signing the informed consent form;
Body Mass Index (BMI) within the range of 18.5 to 40 kg/m² (inclusive of boundary values);
Participants must be at high risk of cardiovascular events, defined as individuals diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) and those at moderate risk or high risk for ASCVD;
Based on clinical practice, participants receiving the following medications must be receiving a stable regimen prior to screening or randomization and expected to remain on a stable regimen at the end of the treatment follow-up period:
Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 1 year after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding;
Willing and able to comply with all the provisions of the protocol, including demonstrating the ability to adhere to study procedures prior to random assignment.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of AFMU | Xi’an | Shanxi | 710038 | China | ||
| The First Affiliated Hospital of Xi'an Jiaotong University |
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| HRS-5632 Injection Placebo | Drug | HRS-5632 injection placebo. |
|
| The percentage of treatment-related adverse events. |
| From Day 1 to Day 540. |
| The percentage of treatment-related serious adverse events. | From Day 1 to Day 540. |
| The percentage of participants achieving Lipoprotein(a) (Lp(a)) < 125 Nanomole/Liter (nmol/L). | Day 540. |
| The percentage of participants achieving Lipoprotein(a) (Lp(a)) < 75 Nanomole/Liter (nmol/L). | Day 540. |
| The plasma concentration of HRS-5632. | From Day 1 to Day 540. |
| Xi’an |
| Shanxi |
| 710061 |
| China |