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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06009393
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
2. LDL-C ≥2.6mmol/L at the screening visit
3. Body weight ≥40 kg
4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.
Exclusion Criteria:
1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
2. eGFR \<30ml/min/1.73m2 at the screening visit
3. CK \>5times ULN at the screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06009393
Study Brief:
Protocol Section:
NCT06009393