A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins

简要总结

主要结局

次要结局

• Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24(Baseline, Week 24)
• Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24(Baseline, Week 12, 24)
• Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24(Baseline, Week 12, 24)
• Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24(Baseline, Week 12, 24)
• Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24(Baseline, Week 12, 24)
• Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24(Week 12, 24)
• Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24(Week 12, 24)
• Plasma PF-04950615 Concentrations at Weeks 12 and 24(Week 12 and 24)
• Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations(Baseline (Day 1) up to Week 30)
• Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)(Baseline up to Week 30)
• Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively(Week 4, 12, 24 and 30 (Follow-up))
• Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations(Baseline (Day 1) up to Week 30)