Atherosclerotic cardiovascular disease (ASCVD)
Conditions
Interventions
Multiple administration experimental group:obicetrapib dose 10mg
Multiple administration control group:placebo dose 10mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is willing and able to sign a written informed consent prior to the commencement of any study-related procedures and is willing to comply with all required study procedures; 2. No gender limit, aged >=18 years at the time of screening (visit 1); (1) Women can be included in this study if they meet all three of the following criteria: (2) Not pregnant; (3) Not in the lactation period; (4) Pregnancy was not planned during the study period; (5) Fertile women must have a negative urine pregnancy test at the time of screening (interview 1). Note: Women may be considered infertile if they meet one of the following criteria documented by the investigator: (6) Hysterectomy or tubal ligation had been performed before signing the informed consent, and at least 1 menstrual cycle had been separated; (7) Postmenopausal, defined as women >=55 years of age >=1 year from their last menstrual period, or women =1 year from their last menstrual period with follicle stimulating hormone levels in the menopausal range; (8) Fertile women must consent to an effective contraceptive method for 35 days from screening (visit 1) to the last dose of the study drug. Men with fertile partners must consent to use effective contraceptive methods for 35 days from screening (visit 1) to the last visit. Effective methods of contraception are the continuous and correct use of contraceptive methods with a Pearl index of less than 1 (including contraceptive implants, injectable contraceptives, oral contraceptives, percutaneous contraceptives, intrauterine devices, contraceptive diaphragms containing spermicide, male or female condoms containing spermicide or cervical caps) or sterilization of sexual partners; 3. A history of ASCVD, defined as meeting at least one of the following conditions: (1) Coronary artery disease: (2) Myocardial infarction; (3) Previous coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting); (4) Angiography or computed tomography (CT) showing (e.g., multislice CT or CT angiography) evidence of coronary atherosclerosis with stenosis > 70% in at least one epicardial major coronary artery; (5) Cerebrovascular diseases: (6) Previous ischemic stroke confirmed by brain imaging studies (CT or MRI), not considered to be caused by atrial fibrillation, valvular heart disease, or mural thrombosis; (7) Previous angiography or ultrasound showed carotid artery stenosis > 70%; (8) History of percutaneous or surgical carotid artery reconstruction; (9) Peripheral artery disease; (10) Resting ankle-brachial index was less than or equal to 0.85; (11) History of percutaneous or surgical reconstruction of the iliac, femoral, or popliteal arteries; (12) Previous non-traumatic amputation of lower limbs due to peripheral artery disease; 4. Receiving maximum tolerance lipid-regulation therapy, as defined below: (1) Taking the maximum tolerated stable dose of statins; (2) The maximum tolerated statin dose of the subject will be determined by the investigator using his medical judgment and available sources, including the subject's self-reported history of lipid-regulation therapy at least 4 weeks prior to screening (visit 1); (3) For subjects not receiving statins because of statin intolerance, subject and investigator are required to provide written confirmation that subjects are intolerant to statins, aware of the benefit of statins in reducing the risk of MACE, and aware that many other patients who
Exclusion criteria
Exclusion criteria: 1. Current or past history of New York Heart Association Class III or IV heart failure (HF) or left ventricular ejection fraction =160 mmHg or diastolic blood pressure >=100 mmHg before randomization, averaged over three repeated measurements. A repeat retest is allowed during the same visit (taking the average of the three repeat measurements), at which point subjects can be randomized if the retest results are no longer exclusionable; 5. Formal diagnosis of familial homozygous hypercholesterolemia; 6. Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; Unexplained elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) at screening; Total bilirubin > 2xULN; Note: Abnormal test values for alanine aminotransferase, aspartate aminotransferase, or total bilirubin must be confirmed by repeated measurements at least 1 week apart. 7. HbA1c>=10% during screening; 8. Thyroid stimulating hormone > 1.5xULN during screening; 9. Creatine kinase > 3xULN during screening; 10. A history of malignancies requiring surgery (excluding local and extensive local excision), radiotherapy, and/or systemic treatment within the 3 years prior to randomization; 11. A known history of alcohol and/or drug abuse within 5 years prior to randomization; 12. Received treatment with another study drug or device within 30 days prior to screening or within 5 half-lives of the previous study drug, whichever is the older; 13. Plan to use other study drugs or devices during the study; 14. Participated in any clinical studies evaluating Obicetrapib; 15. Known allergic or hypersensitive reactions to the study drug, placebo, or any excipients in the study drug or placebo; 16. The Investigator believes that subjects have conditions that may interfere with the conduct of the study, including but not limited to: (1) Inability to communicate or cooperate with researchers; (2) Inability to understand study protocol requirements, specifications, and limitations associated with the study, as well as the nature, scope, and possible consequences of the study (including drug abuse or alcohol dependence affecting the cooperating subject); (3) Inability to follow protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and impossibility to complete the study); (4) Any medical or surgical condition that the investigator believes would increase the subject's risk for study participation; (5) Participants directly involved in the implementation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular death;Nonfatal myocardial infarction;Non-fatal stroke;Non-selective coronary revascularization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event occurrence time;Number of events;Proportion of events;Adverse event (AE);Event of special interest (ESI);Vital sign;Electrocardiogram;Clinical laboratory evaluation; | — |
Countries
China
Contacts
Public ContactQi Litong
Peking University First Hospital
Outcome results
None listed