Monoclonal antibody against PCSK9 to reduce elevated LDL-C in subjects currently not receiving drug therapy for easing lipid levels-2MENDEL-2
Study Details
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
Protocol Summary
Mean percent change from baseline in low density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol
Timeframe: 12 weeks
Mean change from baseline in low density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Change from baseline in low density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
Timeframe: 10 and 12 Weeks
Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
Timeframe: 12 Weeks
Mean percent change from baseline in non-high density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in non-high density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B
Timeframe: 12 Weeks
Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
Timeframe: 12 Weeks
Mean percent change from baseline in lipoprotein (a)
Timeframe: 10 and 12 Weeks
Percent change from baseline in lipoprotein (a)
Timeframe: 12 Weeks
Mean percent change from baseline in triglycerides
Timeframe: 10 and 12 Weeks
Percent change from baseline in triglycerides
Timeframe: 12 Weeks
Mean percent change from baseline in high density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in high density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean percent change from baseline in very low density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in very low density lipoprotein-cholesterol
Timeframe: 12 Weeks