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| Name | Class |
|---|---|
| AD Pharmaceuticals Co., Ltd. | INDUSTRY |
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This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK102 450 mg | Experimental | Participants received AK102 450 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
|
| AK102 300 mg | Experimental | Participants received AK102 300 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
|
| AK102 150 mg | Experimental | Participants received AK102 150 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks |
|
| Placebo Q4W | Placebo Comparator | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
|
| Placebo Q2W | Placebo Comparator | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK102 | Drug | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12 | At baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) | From baseline through 12 weeks | |
| Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) | From baseline through 12 weeks |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuyang Zhang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Yujie Zhou, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| Peking Union Medical College Hospital |
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| Placebo | Drug | Administered by subcutaneous injection |
|
| Statins and/or Ezetimibe | Drug | Lipid-lowering therapies |
|
| Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol | From baseline through 12 weeks |
| Percent change from baseline in serum Triglyceride (TG) cholesterol | From baseline through 12 weeks |
| Percent change from baseline in Apolipoprotein B (Apo B) | From baseline through 12 weeks |
| Percent change from baseline in Apolipoprotein A-I (ApoA-I) | From baseline through 12 weeks |
| Percent change from baseline in Lipoprotein(a) [Lp-(a)] | From baseline through 12 weeks |
| Percent change from baseline in Total Cholesterol(TC) | From baseline through 12 weeks |
| Incidence of treatment-emergent adverse events | From baseline through 12 weeks |
| Serum concentrations of AK102 | From baseline through 12 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 12 weeks |
| Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) | From baseline through 12 weeks |
| Beijing |
| 100000 |
| China |