Dyslipidemia
Conditions
Interventions
- 2.5 mg obicetrapib (one 2.5 mg obicetrapib tablet)
- 5 mg obicetrapib (one 5 mg obicetrapib tablet)
- 10 mg obicetrapib (one 10 mg obicetrapib tablet)
or
- Placebo (1 placebo tablet)
Sponsors
Kanmuri Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understanding of the study procedures, willingness to adhere to the study schedules, and agreement to participate in the study by giving written informed consent prior to screening procedures; 2. Japanese men or women, 18 to 80 years of age, inclusive, at the Screening Visit; o Women may be enrolled if all 3 of the following criteria are met: - They are not pregnant; - They are not breastfeeding; and - They do not plan on becoming pregnant during the study. o Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit. Note: Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the Investigator: - They have had a hysterectomy or tubal ligation at a minimum of 1 cycle prior to signing the ICF; or - They are postmenopausal, defined as >=1 year since their last menstrual period for women >=55 years of age or >=1 year since their last menstrual period and have a follicle-stimulating hormone (FSH) level in the postmenopausal range for women 70 mg/dL or non-HDL-C >100 mg/dL, and TG < 400 mg/dL, within the last 3 months. If a historical LDL-C or non-HDL-C, and TG values are not available within the last 3 months, a fasting lipid profile to verify eligibility will be required by the central laboratory at the Screening Visit. 4. Currently receiving stable statin therapy with either atorvastatin 10 or 20 mg/day or rosuvastatin 5 or 10 mg/day ONLY for at least 8 weeks prior to screening with the intention of remaining on the same stable dose throughout the study duration. o Patients on stable statin therapy with either atorvastatin or rosuvastatin AND taking concomitant daily oral ezetimibe as a second line agent are also eligible to participate.
Exclusion criteria
Exclusion criteria: 1. Body mass index >=35 kg/m2 at the Screening Visit; 2. Current clinically active/acute episode of CV disease, including but not limited to: o Major adverse CV event within 3 months prior to randomization, including: - Non-fatal myocardial infarction; - Non-fatal stroke; - Hospitalization for heart failure; or - Hospitalization for unstable angina. o New York Heart Association Functional Classification Class III or IV heart failure. 3. Have an existing diagnosis of homozygous familial hypercholesterolemia; 4. Have an existing diagnosis of CETP deficiency; 5. Glycosylated hemoglobin (HbA1c) >=10% at the Screening Visit; 6. Uncontrolled hypertension, i.e., supine systolic blood pressure >=160 mmHg and/or supine diastolic blood pressure >=100 mmHg, taken as the average of triplicate measurements. One retest will be allowed, at which point if the retest result is no longer exclusionary, the participant may be randomized; 7. Active muscle disease or persistent creatine kinase (CK) concentration >3 x the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result, at which point if the retest result is no longer exclusionary, the participant may be randomized; 8. Estimated glomerular filtration rate (eGFR) 2 x ULN, or total bilirubin >1.5 x ULN; 10. Anemia, defined as hemoglobin concentration <11 g/dL for men and hemoglobin concentration <9 g/dL for women; 11. History of malignancy within 5 years prior to screening, with the exception of non-melanoma skin cancers; 12. History of alcohol and/or drug abuse within 5 years prior to screening; 13. Treatment with a statin that is not either atorvastatin or rosuvastatin; 14. Treatment with other investigational products or devices within 30 days or 5 half-lives, whichever is longer, prior to screening; 15. Treatment with any PCSK9 inhibitor within 10 weeks prior to randomization or bempedoic acid within 2 weeks prior to randomization; 16. Evidence of any other clinically significant, non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participant in the study; or 17. Known CETP inhibitor allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of obicetrapib, compared to placebo, in reducing serum low-density lipoprotein cholesterol (LDL-C) measured at Day 56 (Visit 5) when taken as an adjunct to a pre-existing stable statin therapy regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the effect of obicetrapib, compared to placebo, on serum apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), and high-density lipoprotein cholesterol (HDL-C) concentrations at Day 56 (Visit 5), when taken as an adjunct to pre-existing stable statin therapy; - To assess the mean plasma levels of obicetrapib at steady state on Day 56 (Visit 5) and Day 84 (Visit 6); and - To evaluate the safety and tolerability profile of obicetrapib in Japanese subjects. | — |
Contacts
Public ContactKazuhiro Kanmuri
Ascent Development Services, Inc.
Outcome results
None listed