A Long-term Study of AK102 in Patients With Hypercholesterolemia

March 1, 2023 updated by: Akeso

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking Union Medical College Hospital
        • Contact:
          • Peipei Chen, MD
        • Principal Investigator:
          • Shuyang Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK102
450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
Drug: Statins and/or Ezetimibe
Lipid-lowering therapies
Drug: 450mg AK102
AK102 Q4W
Drug: 300mg AK102
AK102 Q4W
Drug: 150mg AK102
AK102 Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From Baseline in Serum Triglyceride (TG) cholesterol
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Concentrations of AK102 in Serum
Time Frame: From baseline through 52 weeks
From baseline through 52 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From baseline through 52 weeks
The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.
From baseline through 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Collaborators

AD Pharma (Guangdong)

Investigators

  • Principal Investigator: Shuyang Zhang, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

February 17, 2023

Study Completion (Actual)

February 17, 2023

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK102-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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