Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies (TANDEM)
Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Eligibility Criteria
Inclusion Criteria: Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications LDL-C ≥ 70 mg/dL or HDL-C ≥ 100 mg/dL Triglycerides < 500 Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2 Exclusion Criteria: History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <30% Hospitalized for heart failure within the last 5 years Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months Uncontrolled severe hypertension Diagnosis of homozygous FH Liver disease HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN) History of malignancy Creatinine kinase (CK) >3 X ULN Alcohol abuse Treatment with investigational product Treatment with gemfibrozil or ezetimibe Previous participation in a trial evaluating obicetrapib Known allergy to study drugs, placebo or excipients in study drugs of placebo Other condition that would interfere with the conduct of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Combination Therapy
Monotherapy obicetrapib
Monotherapy ezetimibe
Placebo
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
once-daily placebo tablets (2), placebo capsule