The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
PMG Research of Christie Clinic
Champaign, Illinois, United States
PMG Research of Cary
Cary, North Carolina, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was \>400 mg/dL or LDL-C was \<50 mg/dL), the measured values were used in the analysis.
Time frame: Baseline; Week 6
Percent Change From Baseline in Lipid Profile Parameters at Week 6
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Baseline apolipoprotein B (apoB) was measured only at predose/Day 1. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing values were imputed using LOCF, with only post-Baseline values carried forward. non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol.
Time frame: Baseline; Week 6
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6
Percent change is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the predose Day 1/Week 0 (Treatment Visit 1) value. If only one value is available either at Week -1 (Screening Visit 2) or Week 0 (Treatment Visit 1), then that value is used as Baseline. Missing values were imputed using LOCF, with only post-Baseline values carried forward.
Time frame: Baseline; Week 6
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placebo
Sensenbrenner Primary Care
Charlotte, North Carolina, United States
PMG Research of Hickory
Hickory, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States
PMG Research Salisbury
Salisbury, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, United States
...and 1 more locations
Number of Participants With LDL-C <70 mg/dL at Week 6
Analysis was based on LOCF values. If LDL-C was measured (i.e., if TG was \>400 mg/dL or LDL-C was \<50 mg/dL), the measured values were used in the analysis.
Time frame: Week 6
Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6
If LDL-C was measured (i.e., if TG was \>400 mg/dL or LDL-C was \<50 mg/dL), the measured values were used in the analysis.
Time frame: Baseline; Week 6