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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07050134
Eligibility Criteria:
Inclusion Criteria:
1. Willingness to sign the informed consent form before the start of any trial - related activities, with an understanding of the trial's procedures and methods, and a commitment to strictly adhere to the clinical trial protocol to complete the study.
2. Age between 18 and 65 years (not including 65 years), both male and female participants are acceptable.
3. Body Mass Index (BMI) of at least 24 kg/m² at the time of screening.
4. Two fasting triglyceride tests, spaced at least one week apart during the screening period, both showing results of at least 1.7 mmol/L but less than 5.7 mmol/L.
5. Confirmed carotid artery plaque: defined as a local structural change protruding into the carotid artery lumen, which is at least 0.5 mm or 50% greater than the surrounding carotid artery intima - media thickness (IMT), or IMT \> 1.5 mm.
6. Carotid artery stenosis meets the following criteria: in asymptomatic individuals, less than 60%; in symptomatic individuals, less than 50% (by the NASCET method, see Appendix 2).
7. Ability to accept and comply with the therapeutic lifestyle interventions required by the protocol, and to maintain a stable lifestyle during the study period.
Exclusion Criteria:
1. Participants with a confirmed diagnosis of familial chylomicronemia syndrome (FCS) (Fredrickson Type I), apo CII deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III); or participants with a high suspicion of the above three diseases.
2. Participants with a confirmed diagnosis of homozygous familial hypercholesterolemia.
3. Participants with type 1 diabetes mellitus (T1DM) or other types of diabetes; or participants with type 2 diabetes mellitus who are currently receiving hypoglycemic agents.
4. Participants with uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite medication.
5. Participants with a history of malignancy within five years prior to screening (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical carcinoma in situ); or malignancy that occurred more than five years ago but is currently active.
6. Participants with a history of thyroid cancer, multiple endocrine neoplasia type 2, or a relevant family history.
7. Participants with clinically significant gastrointestinal motility disorders (e.g., severe diabetic gastroparesis), who have undergone or plan to undergo gastric bypass or gastric banding surgery during the study period, or who are on long-term use of drugs that directly affect gastrointestinal motility.
8. Participants with a history of acute pancreatitis within the past year, a history of chronic pancreatitis, or a symptomatic history of gallbladder disease (e.g., common bile duct stones, multiple gallstones, etc.) (excluding those who have undergone cholecystectomy).
9. A history of acute myocardial infarction, cerebral hemorrhage, or cerebral infarction (excluding lacunar infarction) before screening; hospitalization due to congestive heart failure, unstable angina pectoris, or transient ischemic attack; previous percutaneous coronary intervention or coronary artery bypass grafting or other cardiac surgery; or congestive heart failure classified as New York Heart Association (NYHA) functional class II or IV; or a history of carotid artery intervention.
10. Major surgery within 3 months prior to screening.
11. Participants with imaging evidence of diffuse carotid artery plaques, or two or more plaques in a single carotid artery.
12. Severe trauma or infection within 4 weeks prior to screening that has not yet resolved.
13. A history of severe active or unstable major depressive disorder (MDD) or other severe mental disorders (such as schizophrenia, bipolar disorder, or other severe mood or anxiety disorders), or a history of suicide attempt.
14. Known allergy to the study drug or its excipients, or a history of severe atopic diseases (such as asthma, urticaria, eczema, etc.) or severe allergic constitution (allergy to two or more foods or two or more drugs), or potential allergy to the study drug or its components or similar drugs.
15. Use of the following target drugs or participation in relevant clinical trials with experimental drugs within 3 months prior to screening, including drugs targeting glucagon - like peptide - 1 receptor (GLP - 1R), glucagon receptor (GCGR), and fibroblast growth factor 21 receptor (FGF21R).
16. Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening or within five half - lives of the investigational drug (whichever is longer).
17. Use of dipeptidyl peptidase - 4 (DPP - 4) inhibitors or participation in relevant clinical trials of DPP - 4 inhibitors and receipt of experimental drugs within 4 weeks prior to screening.
18. Use of lipid - lowering drugs or PCSK9 inhibitors (small interfering RNA class) within 4 weeks prior to screening.
19. Any of the following laboratory test results:
(1) ALT\>3.0×upper limit of normal (ULN) and/or AST\>3.0×ULN and/or TBIL\>1.5×ULN; (2) Creatinine\>1.5×upper limit of normal; or eGFR\<45 mL/min/1.73m². (3) Serum calcium≥35 ng/mL (pg/mL); (4) TSH\<lower limit of normal, or\>10 U/ml; (5) Serum amylase or lipase\>2.0×ULN; (6) Hb\<110 g/L (male) or\<100 g/L (female); (7) Positive HIV - Ab test; (8) HbA1c≥9.0% during screening. 20. Participants with any clinically significant 12 - lead electrocardiogram (ECG) abnormalities at screening:
1. Second - degree Mobitz II or third - degree atrioventricular block;
2. Long QT syndrome or QTcF\>450 ms (male), QTcF\>470 ms (female);
3. Other serious arrhythmias, such as paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, etc.
21\. A history of drug abuse or excessive alcohol consumption within 3 months prior to screening. \[Excessive alcohol consumption is defined as an average weekly intake of more than 21 units for men and more than 14 units for women (1 unit=360 mL beer, or 150 mL wine, or 45 mL spirits with 40% alcohol).\] 22. Pregnant or breastfeeding women, or men or women with reproductive potential who are unwilling to use contraception throughout the study and for a specified period after the study ends \[30 days after the last dose for women or 90 days for men\].
23\. Blood donation or blood loss of≥400 mL or platelet donation within 3 months prior to screening.
24\. Participants with other factors that the investigator considers unsuitable for study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07050134
Study Brief:
Protocol Section:
NCT07050134