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NCT Number: NCT04173793

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

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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Key information

Conditions

Heterozygous Familial Hypercholesterolemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Key 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.

Treatment and study plan

AK102

Drug

Administered by subcutaneous injection

Placebo

Drug

Administered by subcutaneous injection

Statins and/or Ezetimibe

Drug

Lipid-lowering therapies

Primary outcomes

  1. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12

    Time frame: At baseline and week 12

Secondary outcomes

  1. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C)

    Time frame: From baseline through 12 weeks

  2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)

    Time frame: From baseline through 12 weeks

  3. Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol

    Time frame: From baseline through 12 weeks

  4. Percent change from baseline in serum Triglyceride (TG) cholesterol

    Time frame: From baseline through 12 weeks

  5. Percent change from baseline in Apolipoprotein B (Apo B)

    Time frame: From baseline through 12 weeks

  6. Percent change from baseline in Apolipoprotein A-I (ApoA-I)

    Time frame: From baseline through 12 weeks

  7. Percent change from baseline in Lipoprotein(a) [Lp-(a)]

    Time frame: From baseline through 12 weeks

  8. Percent change from baseline in Total Cholesterol(TC)

    Time frame: From baseline through 12 weeks

  9. Incidence of treatment-emergent adverse events

    Time frame: From baseline through 12 weeks

  10. Serum concentrations of AK102

    Time frame: From baseline through 12 weeks

  11. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    Time frame: From baseline through 12 weeks

    The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.

  12. Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9)

    Time frame: From baseline through 12 weeks

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Collaborators

  • AD Pharmaceuticals Co., Ltd.

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of AK102 in Patients With Heterozygous Familial Hypercholesterolemia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2019
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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