A Long-term Study of AK102 in Patients With Hypercholesterolemia

Akeso

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: 150mg AK102; Drug: 300mg AK102; Drug: Statins and/or Ezetimibe; Drug: 450mg AK102

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04173403

AK102-204

Details and patient eligibility

About

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.

Enrollment: 796 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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796 participants in 1 patient group

AK102

Experimental group

Description:

450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;

Treatment:

Drug: 450mg AK102

Drug: 150mg AK102

Drug: 300mg AK102

Drug: Statins and/or Ezetimibe