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A Study to Evaluate the Efficacy and Safety of AK102 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.
Pregnant or lactating women.

Sites / Locations

Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

AK102 regimen 1

AK102 regimen 2

Placebo 1

Placebo 2

Arm Description

Outcomes

Primary Outcome Measures

Percentage change from baseline of serum LDL-C level

Secondary Outcome Measures

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

Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-

The incidence and severity of adverse events (AE)

To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

Full Information

NCT ID

NCT05255094

First Posted

February 9, 2022

Last Updated

February 15, 2022

Sponsor

Akeso

1. Study Identification

Unique Protocol Identification Number

NCT05255094

Brief Title

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

Official Title

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 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

November 3, 2021 (Actual)

Primary Completion Date

April 30, 2022 (Anticipated)

Study Completion Date

July 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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled phase Ⅲ clinical study evaluating the efficacy and safety of AK102 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, 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

450 (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 1

Arm Type

Placebo Comparator

Arm Title

Placebo 2

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

AK102

Intervention Description

Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Intervention Type

Biological

Intervention Name(s)

AK102

Intervention Description

Administered AK102 by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered placebo by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Primary Outcome Measure Information:

Title

Percentage change from baseline of serum LDL-C level

Description

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 TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels

Description

Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-

Time Frame

Week 0-12

Title

The incidence and severity of adverse events (AE)

Description

The incidence and severity of adverse events (AE)

Time Frame

Week 0-12

Title

To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

Description

To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

Time Frame

Week 0-12

Title

Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

Description

Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

Time Frame

Week 0-12

10. Eligibility

Sex

All

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. Pregnant or lactating women.

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

Peking University First Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Huo, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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