Back to results

A Long-term Study of AK102 in Patients With Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

450mg AK102

300mg AK102

150mg AK102

Statins and/or Ezetimibe

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK102

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52

Secondary Outcome Measures

Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0

Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol

Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol

Percent Change From Baseline in Serum Triglyceride (TG) cholesterol

Percent Change From Baseline in Apolipoprotein B (Apo B)

Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)

Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)

Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

Concentrations of AK102 in Serum

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.

Full Information

NCT ID

NCT04173403

First Posted

November 17, 2019

Last Updated

March 1, 2023

Sponsor

Akeso

Collaborators

AD Pharma (Guangdong)

1. Study Identification

Unique Protocol Identification Number

NCT04173403

Brief Title

A Long-term Study of AK102 in Patients With Hypercholesterolemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

February 17, 2023 (Actual)

Study Completion Date

February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

Collaborators

AD Pharma (Guangdong)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

796 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AK102

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

450mg AK102

Intervention Description

AK102 Q4W

Intervention Type

Drug

Intervention Name(s)

300mg AK102

Intervention Description

AK102 Q4W

Intervention Type

Drug

Intervention Name(s)

150mg AK102

Intervention Description

AK102 Q2W

Intervention Type

Drug

Intervention Name(s)

Statins and/or Ezetimibe

Intervention Description

Lipid-lowering therapies

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0

Time Frame