A Long-term Study of AK102 in Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173403
• Other study ID #: AK102-204
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2019
• Est. completion date: February 17, 2023

Study information

• Verified date: March 2023
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• 450mg AK102
AK102 Q4W
• 300mg AK102
AK102 Q4W
• 150mg AK102
AK102 Q2W
• Statins and/or Ezetimibe
Lipid-lowering therapies

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Akeso	AD Pharma (Guangdong)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52		Week 52
Secondary	Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0		From baseline through 52 weeks
Secondary	Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol		From baseline through 52 weeks
Secondary	Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol		From baseline through 52 weeks
Secondary	Percent Change From Baseline in Serum Triglyceride (TG) cholesterol		From baseline through 52 weeks
Secondary	Percent Change From Baseline in Apolipoprotein B (Apo B)		From baseline through 52 weeks
Secondary	Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)		From baseline through 52 weeks
Secondary	Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)		From baseline through 52 weeks
Secondary	Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)		From baseline through 52 weeks
Secondary	Concentrations of AK102 in Serum		From baseline through 52 weeks
Secondary	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