The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.
Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
349
Percent change in calculated low density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline and 12 weeks
Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)
Time frame: Baseline and 12 weeks
Safety using adverse event reports; vital signs
Time frame: up to 21 weeks including screening
Percent change in Apolipoprotein B (ApoB)
Time frame: Baseline and 12 weeks
Percent change in high sensitivity C-reactive protein (hsCRP)
Time frame: Baseline and 12 weeks
Safety using adverse event reports; clinical laboratory results
Time frame: up to 21 weeks including screening
Safety using adverse event reports; rates of muscle-related adverse
Time frame: up to 21 weeks including screening
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Birmingham, Alabama, United States
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Muscle Shoals, Alabama, United States
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Chandler, Arizona, United States
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Beverly Hills, California, United States
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Chino, California, United States
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Lincoln, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Thousand Oaks, California, United States
...and 58 more locations