Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT04173793
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04173793
Study Brief:
Protocol Section:
NCT04173793