Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1301 Group A | Experimental |
| |
| HRS-1301 Group B | Experimental |
| |
| HRS-1301 Group C | Experimental |
| |
| HRS-1301 Group D | Experimental |
| |
| HRS-1301 Group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1301 | Drug | HRS-1301 Dose 1,oral |
| |
| HRS-1301 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C relative to baseline | at 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving LDL-C goals | at 12 weeks of treatment | |
| Percentage change in TC relative to baseline; | at 12 weeks of treatment | |
| Percentage change in HDL-C relative to baseline; |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miaomiao Shi | Contact | 18036617171 | Miaomiao.shi@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Affiliated Hospital of Harbin | Recruiting | Harbin | Heilongjiang | 150086 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
HRS-1301 Dose 2,oral |
|
| HRS-1301 | Drug | HRS-1301 Dose 3,oral |
|
| HRS-1301 | Drug | HRS-1301 Dose 4,oral |
|
| Placebo | Drug | Placebo,oral |
|
| at 12 weeks of treatment |
| Percentage change in TG relative to baseline; | at 12 weeks of treatment |
| Percentage change in non-HDL-C relative to baseline; | at 12 weeks of treatment |
| Percentage change in ApoB relative to baseline; | at 12 weeks of treatment |
| Percentage change in ApoA1 relative to baseline; | at 12 weeks of treatment; |
| Percentage change in Lp(a) relative to baseline; | at 12 weeks of treatment; |
| Percentage change in hsCRP relative to baseline; | at 12 weeks of treatment; |
| Number of participants with one or more adverse events | during the study period;Approximately half a year |