Supplementary Table 2: Predicted serum LDLc data based on Phase 2 trial simulations using the statin
model. The values indicate the mean of 100 simulated trials* and the parentheses include 90% prediction
intervals.
Dose
Regimen
Nadir
LDLc
(mg/dL)
% Subjects
(nadir < 15
mg/dL)
Mean EOI
LDLc
(mg/dL)
% Subjects
(EOI LDLc
< 70 mg/dL)
LDLc
Reduction @
EOI (mg/dL)
150
Q4W
35 [25 ,48]
5 [0 ,15]
43 [33 ,56]
94 [81 ,100]
-72 [-82 ,-59]
200
Q4W
31 [21 ,41]
8 [0 ,22]
38 [28 ,48]
98 [93 ,100]
-77 [-86 ,-67]
300
Q4W
26 [17 ,37]
17 [0 ,46]
32 [22 ,43]
99 [96 ,100]
-83 [-93 ,-73]
400
Q4W
25 [18 ,36]
17 [0 ,43]
30 [23 ,41]
99 [98 ,100]
-85 [-93 ,-74]
300
Q8W
31 [23 ,42]
8 [0 ,23]
65 [53 ,75]
62 [39 ,84]
-50 [-61 ,-39]
400
Q8W
27 [19 ,36]
15 [1 ,39]
57 [46 ,70]
75 [54 ,93]
-57 [-70 ,-47]
600
Q8W
25 [18 ,34]
20 [2 ,42]
49 [39 ,61]
85 [69 ,97]
-66 [-76 ,-54]
800
Q8W
24 [15 ,37]
24 [1 ,59]
45 [31 ,58]
89 [75 ,98]
-70 [-84 ,-57]
600
Q12W
27 [18 ,36]
17 [1 ,44]
82 [70 ,92]
28 [13 ,49]
-33 [-43 ,-24]
800
Q12W
23 [17 ,33]
24 [4 ,50]
74 [61 ,86]
42 [21 ,70]
-41 [-54 ,-30]
1000
Q12W
24 [15 ,33]
24 [3 ,60]
71 [57 ,83]
48 [24 ,71]
-44 [-57 ,-31]
# EOI: End of the interval (24 weeks)
Q4W: Once every 4 week regimen
Q8W: Once every 8 week regimen
Q12W: Once every 12 week regimen
*100 simulated trials included parameter uncertainty