A Long-term Study of AK102 in Patients With Hypercholesterolemia

• Status: Not yet recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Collaborator: AD Pharma (Guangdong)
• Treatments: Ezetimibe

Criteria

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.