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A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

Primary Purpose

Hyperlipidemia

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

AK102

Placebo

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject understand and voluntarily sign the written Inform Consent Form (ICF).
Male or female ≥ 18 to ≤ 80 years of age.
The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
TG ≤ 4.5 mmol/L (400 mg/dl)

Exclusion Criteria:

Known homozygous familial hypercholesterolemia.
Received PCSK9 inhibitors within 6 months before randomization.
Known sensitivity to PCSK9 inhibitors and any substances to be administered.
Severe renal dysfunction.
Previously received organ transplantation.
Uncontrolled hypothyroidism or hyperthyroidism.
Uncontrolled hypertension.
Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
History of malignancy of any organ system within the past 5 years.

Sites / Locations

The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
Zhongshan Hospital, Fudan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

AK102 regimen 1

AK102 regimen 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage change from baseline of serum LDL-C level

Secondary Outcome Measures

Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels

The incidence and severity of adverse events (AE)

Evaluate the changes of AK102 PK parameters(t1/2)

Evaluate the changes of AK102 PK parameters(AUC）

Evaluate the changes of AK102 PK parameters(Vd)

Evaluate the changes of AK102 PK parameters(Tmax)

Evaluate the changes of free PCSK9 concentration

Evaluate the changes of AK102 PK parameters(Cmax)

Evaluate the changes of AK102 PK parameters(CL)

Evaluate the changes of AK102 PK parameters(MRT)

The number and percentage of anti AK102 antibody (ADA)positive subjects

The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects

the time of ADA positive

the time of nab positive

Full Information

NCT ID

NCT05260411

First Posted

February 9, 2022

Last Updated

February 18, 2022

Sponsor

Akeso

1. Study Identification

Unique Protocol Identification Number

NCT05260411

Brief Title

A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

Official Title

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2022 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

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 randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Detailed Description

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

6. Conditions and Keywords

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

Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AK102 regimen 1

Arm Type

Experimental

Arm Title

AK102 regimen 2

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

AK102

Intervention Description

Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Intervention Type

Biological

Intervention Name(s)

AK102

Intervention Description

Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Primary Outcome Measure Information:

Title

Percentage change from baseline of serum LDL-C level

Time Frame

At week 12

Secondary Outcome Measure Information:

Title

Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels

Time Frame

Week 0-24

Title

The incidence and severity of adverse events (AE)

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(t1/2)

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(AUC）

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(Vd)

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(Tmax)

Time Frame

Week 0-24

Title

Evaluate the changes of free PCSK9 concentration

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(Cmax)

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(CL)

Time Frame

Week 0-24

Title

Evaluate the changes of AK102 PK parameters(MRT)

Time Frame

Week 0-24

Title

The number and percentage of anti AK102 antibody (ADA)positive subjects

Time Frame

Week 0-24

Title

The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects

Time Frame

Week 0-24

Title

the time of ADA positive

Time Frame

Week 0-24

Title

the time of nab positive

Time Frame

Week 0-24

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject understand and voluntarily sign the written Inform Consent Form (ICF). Male or female ≥ 18 to ≤ 80 years of age. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment. TG ≤ 4.5 mmol/L (400 mg/dl) Exclusion Criteria: Known homozygous familial hypercholesterolemia. Received PCSK9 inhibitors within 6 months before randomization. Known sensitivity to PCSK9 inhibitors and any substances to be administered. Severe renal dysfunction. Previously received organ transplantation. Uncontrolled hypothyroidism or hyperthyroidism. Uncontrolled hypertension. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc. History of malignancy of any organ system within the past 5 years.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guoqin Wang, MD

Phone

+86 (0760) 8987 3999

global.trials@akesobio.com

Facility Information:

Facility Name

The Second Affiliated Hospital Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JianAn Wang

Facility Name

Zhongshan Hospital, Fudan Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JunBo Ge

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

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