This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
100 mg tablet orally, once daily for 12 weeks
Placebo for anacetrapib orally, once daily for 12 weeks
Percent change from Baseline in Low-density Lipoprotein-Cholesterol (LDL-C) using beta-quantification method
Time frame: Baseline and Week 12
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)
Time frame: 12 weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
Time frame: 12 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)
Time frame: 12 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
Time frame: 12 weeks
Number of Participants with Significant Increase in Blood Pressure
Time frame: 12 weeks
Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
Time frame: Baseline and Week 12
Percent Change from Baseline in Apolipoprotein A-I (apoA-I)
Time frame: Baseline and Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.