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:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06301451
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 (inclusive), gender is not limited;
* Subjects with clinical diagnosis of hyperlipidemia;
* The subjects' fasting LDL-C and carotid artery color Doppler ultrasound meet one of the following requirements: 1. Bilateral carotid artery color Doppler shows no plaque formation, and 2.6 ≤ LDL-C \< 4.92mmol/L; 2. Bilateral or unilateral neck Arterial plaque formation, and 2.6≤LDL-C\<3.4mmol/L;
* 18.5 kg/m2≤BMI≤35 kg/m2, Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2);
* Subjects who are willing to participate in the trial and sign informed consent.
Exclusion Criteria:
* Secondary hyperlipidemia caused by systemic diseases (such as nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, liver disease or renal failure, etc.);
* Fasting triglycerides \> 5.6 mmol/L;
* Diabetic patients;
* Those who plan to undergo bariatric surgery (gastric retraction, gastric bypass, gastric banding, etc.) during the study period;
* Have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) ) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.) who intervene;
* Those who have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.);
* Subjects who have used heparin, thyroxine treatment drugs, diuretics, phenothiazines, beta-blockers, adrenal corticosteroids and certain contraceptives in the past 8 weeks, which may affect blood lipid metabolism;
* Combined with malignant tumor or mental disorder;
* Accompanied by severe cardiovascular and cerebrovascular diseases, liver and kidney function damage (NYHA grade greater than or equal to 3, ALT or AST \> 3 times the upper limit of normal, Cr \> 1.5 times the upper limit of normal);
* Those who have participated in clinical trials of other drugs or medical devices within 3 months;
* Those who plan to become pregnant, are pregnant or are breastfeeding during the study period and those who cannot take contraceptive measures;
* Patients deemed unsuitable for participation in this study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06301451
Study Brief:
Protocol Section:
NCT06301451