The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.
Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
133
ETC-1002 capsules, taken once daily oral
Placebo capsules, taken once daily oral
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)
Time frame: 12 weeks
Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: 12 weeks
Percent change in apolipoprotein B (ApoB)
Time frame: 12 weeks
Percent change in total cholesterol (TC)
Time frame: 12 weeks
Percent change in high-sensitivity C-reactive protein (hsCRP)
Time frame: 12 weeks
Percent change in triglycerides (TG)
Time frame: 12 weeks
Percent change in lipoprotein particle number
Time frame: 12 weeks
Safety using adverse event reports; clinical laboratory results
Time frame: 12 weeks
Safety using adverse event reports; vital signs
Time frame: 12 weeks
Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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