| Eligibility |
Inclusion Criteria:
1. Provide a signed and dated informed consent form.
2. Men or women aged =18 and =80 at the time of screening.
3. Body weight = 40 kg at the time of screening.
4. According to British Simon Broome (SBR) standards, HeFH is diagnosed or suspected:
Diagnosis of HeFH: Total cholesterol> 7.5 mmol/L, or LDL-C concentration> 4.9 mmol/L,
and at least one of the following two can be diagnosed: 1) The patient has tendon
xanthoma, or his relatives (first-degree or At least one person at Level 2) has tendon
xanthoma; 2) has evidence of LDL receptor, ApoB-100 or PCSK9 gene mutation; Suspected
HeFH: Total cholesterol> 7.5 mmol/L, or LDL-C concentration> 4.9 mmol/L, and at least
one of the following two is suspected HeFH: 1) Second-degree relatives before 50 years
old or first-degree relatives 60 years old Previous history of myocardial infarction;
2) First-degree or second-degree adult relatives have a history of total
cholesterol>7.5mmol/L or children, brothers, sisters have a history of total
cholesterol>6.7mmol/L before the age of 16 or 16 years old.
5. Maintain a low-fat diet and stably take the current lipid-lowering therapy (taking
moderate-intensity or above statins, except for statin intolerance, with or without
ezetimibe, niacin, and omega fatty acids) for at least 4 weeks. If you are taking
fibrates, the fibrates are treated stably for at least 6 weeks.
6. The fasting LDL cholesterol concentration of patients with a history of
atherosclerotic cardiovascular disease at the time of screening was =1.8 mmol/L; the
fasting LDL cholesterol concentration of patients without a history of atherosclerotic
cardiovascular disease was =2.6 mmol/L.
7. The subject indicated that they are willing and cooperate to complete all the steps in
the study and the study intervention period.
Exclusion Criteria:
1. Patients diagnosed as homozygous familial hypercholesterolemia.
2. He had undergone dialysis or plasma exchange within 4 months before screening.
3. Patients who have received liver transplant surgery in the past.
4. Adjust the treatment plan or dose of statins, ezetimibe, niacin, and omega fatty acids
within 4 weeks before the screening of subjects (these subjects can stabilize the
current lipid-lowering drug dosage for 1 month, and then Re-filter).
5. New York Heart Association (NYHA) grade III or IV heart failure, or recently detected
left ventricular ejection fraction = 30%.
6. Poorly controlled severe arrhythmia, defined as recurrent and highly symptomatic
ventricular tachycardia, atrial fibrillation with rapid ventricular rate or
supraventricular tachycardia.
7. Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary
artery bypass grafting or stroke occurred within 3 months before enrollment.
8. Plan to perform percutaneous coronary intervention, coronary artery bypass grafting or
other heart surgery during the study period.
9. Type 1 diabetes or poor blood sugar control (HbA1c>8.5%), or type 2 diabetes requiring
multiple injections of insulin daily.
10. There are uncontrolled clinical diseases that may affect blood lipids or lipoprotein
levels (in patients with thyroid hormone replacement therapy, the thyroid hormone dose
needs to be stable for at least 6 weeks before the screening visit). Poorly controlled
hypothyroidism or hyperthyroidism is defined as TSH <the lower limit of normal, or>
1.5 times the upper limit of normal.
11. Poorly controlled hypertension is defined as a sitting systolic blood pressure> 180
mmHg or diastolic blood pressure> 110 mmHg confirmed by repeated measurements.
12. Moderate to severe renal insufficiency, defined as the estimated glomerular filtration
rate <30 ml / min / 1.73 m2 during the screening period.
13. Active liver disease or liver function impairment is defined as the screening period
determined by local laboratory analysis, aspartate aminotransferase or alanine
aminotransferase> 3 times the upper limit of normal (ULN).
14. Creatine kinase (CK) = 3 times of ULN during screening.
15. As judged by the investigator, there is a known active infection or major blood,
kidney, metabolic, gastrointestinal, or endocrine dysfunction.
16. Once diagnosed with deep vein thrombosis or pulmonary embolism.
17. Except for those who have been sterilized or menopausal, female subjects with
potential for pregnancy, if they are unwilling to inform their sexual partners that
they will participate in the clinical study, and take effective measures during the
use of the study drug and within 15 weeks after the last dose of the study drug
Contraceptive measures. Male subjects are unwilling to inform their female sexual
partners that they participate in the clinical study.
18. Subjects who are pregnant or breastfeeding, or plan to become pregnant or
breastfeeding during the period of study medication or within 15 weeks after the last
dose of study medication.
19. Suffered from malignant tumors in the past 5 years (except for non-melanoma skin
cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast or stage 1
prostate cancer).
20. The subject has received PCSK9 inhibitor treatment or participated in other studies
that inhibit PCSK9.
21. Known allergy to study drug and its ingredients.
22. Those who are judged by the investigator to be unsuitable to participate in the study
(for example, alcohol or other drug abuse, inability or unwillingness to comply with
the agreement, or mental illness).
23. Currently participating in another medical device or drug research, or the previous
medical device or drug clinical research has ended, or receiving other research drugs
for less than 30 days.
24. In any other circumstances, the investigator or sponsor believes that it may impair
the subject's ability or safety to give written informed consent and/or comply with
all necessary research procedures.
25. Human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),
hepatitis C (HCV) antibodies, HIV or syphilis antibodies were positive at the time of
screening.
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