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 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT07295418
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18 to 75 years (inclusive).
* Fasting LDL-C ≥2.6 mmol/L and \<4.9 mmol/L at screening/randomization.
* Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes).
* Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization.
* Provides written informed consent.
Exclusion Criteria:
* Diagnosis of familial hypercholesterolemia (HoFH or HeFH).
* History of atherosclerotic cardiovascular disease (ASCVD).
* Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
* Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \>8.0%).
* Significant hepatic or renal impairment.
* Active liver disease or positive for HIV or Syphilis.
* History of malignancy within 5 years prior to screening.
* Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening.
* Prior treatment with any PCSK9 inhibitor.
* Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies.
* Any other condition deemed by the investigator to be unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07295418
Study Brief:
Protocol Section:
NCT07295418