A Long-term Study of AK102 in Patients With Hypercholesterolemia

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: 450mg AK102
* Drug: 300mg AK102
* Drug: 150mg AK102
* Drug: Statins and/or Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Body weight ≥ 40 kg for both men and women. Participated in the AK102-202 study, and completed the AK102-202 study last visit. Exclusion Criteria: Poor compliance in AK102-202 study per investigator's judgement. AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period. Prior use of PCSK9 inhibitors other than AK102.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK102<br>450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection; | Drug: 450mg AK102<br>* AK102 Q4W<br>Drug: 300mg AK102<br>* AK102 Q4W<br>Drug: 150mg AK102<br>* AK102 Q2W<br>Drug: Statins and/or Ezetimibe<br>* Lipid-lowering therapies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52 |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |