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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT06684106
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years old.
* LDL-C≥3.4mmol/l (130 mg/dL).
* Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
* Voluntarily sign informed consent.
Exclusion Criteria:
* Previous diagnosis of diabetes or prediabetes.
* Past or current use of hypoglycemic drugs.
* Oral administration of statin lipid-lowering drugs within three months before enrollment.
* Combined oral drug quantity ≥3.
* History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease).
* Active liver disease (defined as elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) from any existing known liver infectious, neoplastic, or metabolic pathologic cause or unknown cause at the time of screening), Severe hepatic insufficiency and biliary obstruction.
* Difficult to control hypertension: defined as systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite antihypertensive therapy prior to randomization.
* Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method
* New York Heart Association (NYHA) Class IV heart failure or a known left ventricular ejection fraction \< 25%
* A clinically significant and drug- or ablation-resistant arrhythmia within 3 months prior to randomization
* An acute or severe systemic infection, or any of the following diseases: hematological disorders, autoimmune disorders, malignant tumors, psychiatric patients, or other serious or unstable conditions that could impact study health status
* Scheduled for surgery within 6 months
* Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion
* Subjects with alcohol or other drug addiction
* Secondary hypercholesterolemia, such as hypothyroidism or nephrotic syndrome
* A history of allergic reaction to any study drug or its excipients or similar chemical classes of drugs
* A family history of homozygous familial hypercholesterolemia
* Participants currently enrolled in another clinical trial, or who cannot adhere to 6-month follow-up
* Any condition that the investigator considers unsuitable for participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06684106
Study Brief:
Protocol Section:
NCT06684106