A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2022-09-26

Brief Summary

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This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.

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Detailed Description

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Conditions

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Heterozygous Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AK102 450 mg

Participants received AK102 450 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

Administered by subcutaneous injection

Statins and/or Ezetimibe

Intervention Type DRUG

Lipid-lowering therapies

AK102 300 mg

Participants received AK102 300 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

Administered by subcutaneous injection

Statins and/or Ezetimibe

Intervention Type DRUG

Lipid-lowering therapies

AK102 150 mg

Participants received AK102 150 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

Administered by subcutaneous injection

Statins and/or Ezetimibe

Intervention Type DRUG

Lipid-lowering therapies

Placebo Q4W

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection

Statins and/or Ezetimibe

Intervention Type DRUG

Lipid-lowering therapies

Placebo Q2W

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection

Statins and/or Ezetimibe

Intervention Type DRUG

Lipid-lowering therapies

Interventions

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AK102

Administered by subcutaneous injection

Intervention Type DRUG

Placebo

Administered by subcutaneous injection

Intervention Type DRUG

Statins and/or Ezetimibe

Lipid-lowering therapies

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with heterozygous familial hypercholesterolemia diagnosed by genetic confirmation or clinical diagnosis criteria.
* Stable on pre-existing, lipid-lowering therapies (statins with or without ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation.
* Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 70 mg/dL in patients with history of Atherosclerotic Cardiovascular Disease (ASCVD) or Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL in patients without history of Atherosclerotic Cardiovascular Disease (ASCVD).
* Fasting triglycerides ≤ 400 mg/dL.
* Body weight ≥ 40kg.

Exclusion Criteria

* Subjects with homozygous FH (clinically or by genotyping).
* Receipt of LDL apheresis within 12 months prior to the first dose of Investigational product.
* Receipt of Lomitapide or Mipomersen within 5 months prior to the first dose of Investigational product.
* Prior use of PCSK9 inhibitors.
* Creatine kinase (CK) \>3 times of the upper limit of normal (ULN).
* Aspartate Aminotransferase (AST) ≥ 2 x ULN.
* Estimated Glomerular Filtration Rate (eGFR)≤ 30 mL/min/1.73m\^2.
* Thyroid-Stimulating Hormone (TSH)\> 1.5 x ULN or \<1 x LLN.
* Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c\> 8.5%).
* Subjects with untreated or active chronic hepatitis B or active hepatitis C virus infections.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No