A Long-term Study of AK102 in Patients With Hypercholesterolemia
A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia
1 other identifier
interventional
796
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2019
CompletedFirst Submitted
Initial submission to the registry
November 17, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2023
CompletedMarch 2, 2023
March 1, 2023
3.3 years
November 17, 2019
March 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
Week 52
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
AK102
EXPERIMENTAL450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
- AD Pharma (Guangdong)collaborator
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuyang Zhang
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2019
First Posted
November 22, 2019
Study Start
November 4, 2019
Primary Completion
February 17, 2023
Study Completion
February 17, 2023
Last Updated
March 2, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share