atherosclerotic cardiovascular disease (ASCVD) MedDRA version: 26.0 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 100000004866 MedDRA version: 20.0 Level: LLT Classification code 10076622 Term: Atherosclerotic plaque System Organ Class: 100000004866
Conditions
Sponsors
NewAmsterdam Pharma BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female and =18 years of age at Screening (Visit 1); - Have a history of ASCVD, defined by at least 1 of the following conditions: o Coronary artery disease o Cerebrovascular disease o Peripheral arterial disease - Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid lowering diet and other lifestyle modifications, defined as follows: o A statin at a maximally tolerated stable dose; o Ezetimibe for at least 8 weeks with or without a maximally tolerated statin prior to Screening (Visit 1); o Bempedoic acid for at least 8 weeks in combination with a maximally tolerated statin prior to Screening (Visit 1); and/or o A PCSK9-targeted therapy alone or in combination with other lipidmodifying therapy for at least 4 stable doses prior to Screening (Visit o At least 70% of the participants enrolled into this study must be taking HISs. Documentation in the eCRF of the reason why a participant is unable to take HISs is required. HISs include the following: o Atorvastatin 40 and 80 mg; and o Rosuvastatin 20 and 40 mg - Have a fasting serum LDL-C at Screening (Visit 1) as follows: o Have a fasting serum LDL-C =70 mg/dL to 3 and 150 mg/dL (>1.7 mmol/L); and/or - Fasting high density lipoprotein cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range 4950
Exclusion criteria
Exclusion criteria: 1. Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction 3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1); 7. Have an HbA1c =10.0% or a fasting glucose =270 mg/dL at Screening (Visit 1); 8. Have a thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1); 9. Have a creatine kinase >3 × ULN at Screening (Visit 1); 10. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1). Other protocol-defined criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.;Secondary Objective: • CV death, non-fatal MI, or non-fatal stroke; • All-cause mortality, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization; • Total CV events; • Any individual component of the primary composite endpoint; • All-cause mortality; • New-onset diabetes mellitus (NODM); • Percent change in low-density lipoprotein cholesterol (LDL-C); • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C); • Percent change in apolipoprotein B (ApoB); and • Absolute change in glycosylated hemoglobin (HbA1c) in participants with diabetes mellitus and HbA1c =7% at Baseline.;Primary end point(s): EFFICACY 1) the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization. SAFETY 2) AEs and events of special interest (ESIs); 3) Vital signs (including blood pressure); 4) Electrocardiograms; and 5) Clinical laboratory assessment;Timepoint(s) of evaluation of this end point: 1) Baseline to EOS 2) V1 to EOT and EOS 3) V1, V2, V4, V5, V6+Q6M, EOT 4) Visit 2, EOT 5) V1, V2, V4, V5, V6+Q6M, EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints, in hierarchical order, include the following: 1) The time from Randomization until the first confirmed occurrence of a composite of CV death, non-fatal MI, or non-fatal stroke; 2) The time from Randomization until the first confirmed occurrence of a composite of all-cause mortality, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization; 3) A total event analysis, defined as the number of CV death events, and first and subsequent/recurrent events of non-fatal MIs, non-fatal strokes, and non-elective coronary revascularization from Randomization until the EOS Visit; 4) The time from Randomization until the first confirmed occurrence of non-fatal MI; 5) The time from Randomization until the first confirmed occurrence of non-elective coronary revascularization; 6) The time from Randomization until the confirmed occurrence of CV death; 7) The time from Randomization until the first confirmed occurrence of non-fatal stroke; 8) The time from Randomization until the confirmed occurrence of all-cause mortality; 9) The time from Randomization until the first confirmed occurrence of NODM; 10) Percent change in LDL-C from Baseline to Day 365 and to the EOT Visit; 11) Percent change in non-HDL-C from Baseline to Day 365 and to the EOT Visit; 12) Percent change in ApoB from Baseline to Day 365; and 13) Percent change in HbA1c in participants with diabetes mellitus and HbA1c =7% at Baseline, from Baseline to Day 365 and to the EOT Visit. ;Timepoint(s) of evaluation of this end point: 1,2,3,4,5,6,8) Baseline to EOS 7) EOS 9,10,12) Baseline, Day 365/EOT 11) Baseline to Day 365 | — |
Countries
Australia, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, European Union, Finland, Georgia, Germany, Hungary, Israel, Italy, Japan, Jordan, Latvia, Netherlands, Slovakia, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactClinical Operations
NewAmsterdam Pharma BV
Outcome results
None listed