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| Name | Class |
|---|---|
| AD Pharma (Guangdong) | UNKNOWN |
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This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK102 | Experimental | 450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 450mg AK102 | Drug | AK102 Q4W |
| |
| 300mg AK102 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0 | From baseline through 52 weeks | |
| Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol | From baseline through 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuyang Zhang | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Drug |
AK102 Q4W |
|
| 150mg AK102 | Drug | AK102 Q2W |
|
| Statins and/or Ezetimibe | Drug | Lipid-lowering therapies |
|
| Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol | From baseline through 52 weeks |
| Percent Change From Baseline in Serum Triglyceride (TG) cholesterol | From baseline through 52 weeks |
| Percent Change From Baseline in Apolipoprotein B (Apo B) | From baseline through 52 weeks |
| Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) | From baseline through 52 weeks |
| Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC) | From baseline through 52 weeks |
| Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | From baseline through 52 weeks |
| Concentrations of AK102 in Serum | From baseline through 52 weeks |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies. | From baseline through 52 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |