Familial heterozygous hypercholesterolemia (HeFH)/Atherosclerotic cardiovascular disease (ASCVD)
Conditions
Interventions
Experimental group:Obicetrapib dose 10mg
Control group:Single dose of placebo
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: (1) Women met the criteria of not being pregnant, not lactating, and not planning to become pregnant during the study period; (2) Fertile women must have a negative urine pregnancy test at the time of screening; (3) A fertile woman must consent to the use of an effective contraceptive method from the time of signing the informed consent form until the EOS visit. Men with fertile partners must consent to the use of effective contraceptive methods from the time of signing the informed consent form until the EOS visit. Effective methods of contraception refer to the continuous and correct use of contraceptive methods with a Pearl index 3 months and 150 mg/dL (> 1.7 mmol/L), fasting Lp (a) > 30 mg/dL (> 70 nmol/L), and/or fasting HDL-C =100 mg/dL; 6. Fasting TG<400 mg/dL (<4.52 mmol/L) during screening; 7. An estimated glomerular filtration rate of 30 mL/min/1.73 m^2 was calculated using the formula for the Collaborative Study on Epidemiology of Chronic Kidney Disease at screening.
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; 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 |
|---|---|
| Low-density lipoprotein cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-high-density lipoprotein cholesterol;High-density lipoprotein cholesterol;Total cholesterol;Triglycerides;Adverse event;Vital sign;Electrocardiogram;Clinical laboratory examination; | — |
Countries
China
Contacts
Public ContactQi Litong
Peking University First Hospital
Outcome results
None listed