Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies

JRCT ID: jRCT2031220229

Registered date:30/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dyslipidemia
• Date of first enrollment: 25/07/2022
• Target sample size: 225
• Countries of recruitment: US,Japan,UK,Japan,Spain,Japan,Slovakia,Japan,Poland,Japan,Netherlands,Japan,Italy,Japan,Israel,Japan,Hungary,Japan,Germany,Japan,Finland,Japan,Denmark,Japan,Czech Republic,Japan,Croatia,Japan,China,Japan,Canada,Japan,Bulgaria,Japan,Australia,Japan
• Study type: Interventional
• Intervention(s): One 10 mg tablet of Obicetrapib or Placebo is orally administered QID

Outcome(s)

Primary Outcome

"Major Adverse Cardiovascular Effect (MACE) [ Time Frame: 32 months after last participant randomized ]
To evaluate the effect of obicetrapib on the risk of MACE"

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Males & females 18 years age and more
2. Established ASCVD
3. On maximally tolerated lipid-modifying therapy
4. Fasting LDL-C 70 mg/dL and more
5. Fasting triglycerides under 400 mg/dL
6. Estimated glomerular filtration rate 30 mL/min and more
7. Atorvastatin 10 or 20 mg for non-familial hypercholesterolemia (Japan only);
8. Atorvastatin 20 or 40 mg for heterozygous familial hypercholesterolemia (Japan only); or
9. Rosuvastatin 10 or 20 mg (Japan only)

Exclude criteria

1. New York Heart Association class III or IV heart failure or last known left ventricular ejection fraction under 30%;
2. Have been hospitalized for Heart Failure within 5 years prior to screening
3. Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
4. Uncontrolled hypertension
5. Diagnosis of homozygous familial hypercholesterolemia (HoFH)
6. Active liver disease
7. HbA1c 10% and more or a fasting glucose 270 mg/dL and more at Screening (Visit 1)
8. Thyroid Stimulating Hormone (TSH) over 1.5 times upper limit normal at Screening (Visit 1)
9. Creatine kinase over 3 times upper limit normal at Screening (Visit 1)
10. History of malignancy with surgery in past 3 years
11. History of alcohol or drug abuse within past 5 years
12. Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
13. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
14. Known allergy to study drug
15. Participated in previous obicetrapib trial
16. Patients who meet the lipid management targets as specified in the 2022 Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (only for Japan); or
17. Have an existing diagnosis of CETP deficiency (only for Japan)

Related Information

• Primary Sponsor: Toshihiro Hokonohara
• Secondary ID(s): NCT05202509