Hypercholesterolemia
Conditions
Brief summary
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.
Interventions
DRUG450mg AK102
AK102 Q4W
DRUG300mg AK102
AK102 Q4W
DRUG150mg AK102
AK102 Q2W
Lipid-lowering therapies
Sponsors
AD Pharma (Guangdong)
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent. 2. Body weight ≥ 40 kg for both men and women. 3. Participated in the AK102-202 study, and completed the AK102-202 study last visit.
Exclusion criteria
1. Poor compliance in AK102-202 study per investigator's judgement. 2. AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period. 3. Prior use of PCSK9 inhibitors other than AK102.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52 | Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0 | 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) | From baseline through 52 weeks | The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies. |
| Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) | From baseline through 52 weeks | — |
Countries
China
Outcome results
None listed