Trial Outcomes & Findings for Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 (NCT NCT01763827)
NCT ID: NCT01763827
Last Updated: 2022-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
615 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-11-08
Participant Flow
Men and women ≥ 18 to ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL and fasting triglycerides ≤ 400 mg/dL with a 10-year Framingham Risk Score of 10% or less were eligible for this study. The first participant was enrolled on 21 January 2013 and the last participant was enrolled 29 July 2013.
Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6 week screening period. Participants who completed the screening period and met final eligibility criteria were randomized 1:1:1:1:2:2 into 6 treatment groups. Randomization was stratified by LDL-C concentration (\< 130 mg/dL or ≥ 30 mg/dL).
Participant milestones
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
77
|
77
|
153
|
153
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
76
|
78
|
77
|
77
|
153
|
153
|
|
Overall Study
COMPLETED
|
74
|
77
|
73
|
76
|
147
|
151
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
1
|
6
|
2
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Decision by sponsor
|
2
|
0
|
3
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
2
|
1
|
Baseline Characteristics
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Total Cholesterol/High-density Lipoprotein Cholesterol Ratio
|
4.148 ratio
STANDARD_DEVIATION 1.311 • n=5 Participants
|
4.444 ratio
STANDARD_DEVIATION 1.465 • n=7 Participants
|
4.055 ratio
STANDARD_DEVIATION 1.082 • n=5 Participants
|
4.335 ratio
STANDARD_DEVIATION 1.118 • n=4 Participants
|
4.170 ratio
STANDARD_DEVIATION 1.170 • n=21 Participants
|
4.175 ratio
STANDARD_DEVIATION 1.071 • n=10 Participants
|
4.210 ratio
STANDARD_DEVIATION 1.191 • n=115 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.671 ratio
STANDARD_DEVIATION 0.193 • n=5 Participants
|
0.713 ratio
STANDARD_DEVIATION 0.194 • n=7 Participants
|
0.691 ratio
STANDARD_DEVIATION 0.187 • n=5 Participants
|
0.712 ratio
STANDARD_DEVIATION 0.173 • n=4 Participants
|
0.687 ratio
STANDARD_DEVIATION 0.169 • n=21 Participants
|
0.707 ratio
STANDARD_DEVIATION 0.170 • n=10 Participants
|
0.697 ratio
STANDARD_DEVIATION 0.178 • n=115 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
52.9 years
STANDARD_DEVIATION 12.1 • n=10 Participants
|
53.1 years
STANDARD_DEVIATION 12.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
101 Participants
n=10 Participants
|
406 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
209 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=10 Participants
|
58 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=10 Participants
|
40 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
64 participants
n=5 Participants
|
63 participants
n=7 Participants
|
63 participants
n=5 Participants
|
60 participants
n=4 Participants
|
132 participants
n=21 Participants
|
129 participants
n=10 Participants
|
511 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
11 participants
n=4 Participants
|
14 participants
n=21 Participants
|
21 participants
n=10 Participants
|
69 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
68 participants
n=5 Participants
|
66 participants
n=4 Participants
|
139 participants
n=21 Participants
|
132 participants
n=10 Participants
|
546 participants
n=115 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C)
< 130 mg/dL
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
45 participants
n=21 Participants
|
45 participants
n=10 Participants
|
181 participants
n=115 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C)
≥ 130 mg/dL
|
54 participants
n=5 Participants
|
54 participants
n=7 Participants
|
55 participants
n=5 Participants
|
55 participants
n=4 Participants
|
108 participants
n=21 Participants
|
108 participants
n=10 Participants
|
434 participants
n=115 Participants
|
|
LDL-C Concentration
|
139.5 mg/dL
STANDARD_DEVIATION 21.3 • n=5 Participants
|
144.3 mg/dL
STANDARD_DEVIATION 23.9 • n=7 Participants
|
143.3 mg/dL
STANDARD_DEVIATION 23.8 • n=5 Participants
|
143.5 mg/dL
STANDARD_DEVIATION 23.1 • n=4 Participants
|
141.7 mg/dL
STANDARD_DEVIATION 22.3 • n=21 Participants
|
144.4 mg/dL
STANDARD_DEVIATION 23.3 • n=10 Participants
|
142.9 mg/dL
STANDARD_DEVIATION 22.9 • n=115 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration
|
167.4 mg/dL
STANDARD_DEVIATION 25.8 • n=5 Participants
|
172.8 mg/dL
STANDARD_DEVIATION 31.0 • n=7 Participants
|
168.8 mg/dL
STANDARD_DEVIATION 28.9 • n=5 Participants
|
169.4 mg/dL
STANDARD_DEVIATION 27.3 • n=4 Participants
|
166.5 mg/dL
STANDARD_DEVIATION 25.6 • n=21 Participants
|
170.4 mg/dL
STANDARD_DEVIATION 26.6 • n=10 Participants
|
169.0 mg/dL
STANDARD_DEVIATION 27.2 • n=115 Participants
|
|
Apolipoprotein B Concentration
|
103.7 mg/dL
STANDARD_DEVIATION 16.8 • n=5 Participants
|
107.3 mg/dL
STANDARD_DEVIATION 19.9 • n=7 Participants
|
107.2 mg/dL
STANDARD_DEVIATION 19.7 • n=5 Participants
|
106.2 mg/dL
STANDARD_DEVIATION 17.8 • n=4 Participants
|
104.5 mg/dL
STANDARD_DEVIATION 17.2 • n=21 Participants
|
108.3 mg/dL
STANDARD_DEVIATION 17.9 • n=10 Participants
|
106.2 mg/dL
STANDARD_DEVIATION 18.1 • n=115 Participants
|
|
Lipoprotein(a)
|
21.0 nmol/L
INTER_QUARTILE_RANGE 62.9 • n=5 Participants
|
21.5 nmol/L
INTER_QUARTILE_RANGE 84.0 • n=7 Participants
|
28.0 nmol/L
INTER_QUARTILE_RANGE 79.1 • n=5 Participants
|
28.0 nmol/L
INTER_QUARTILE_RANGE 65.7 • n=4 Participants
|
20.0 nmol/L
INTER_QUARTILE_RANGE 61.5 • n=21 Participants
|
28.0 nmol/L
INTER_QUARTILE_RANGE 86.9 • n=10 Participants
|
25.0 nmol/L
INTER_QUARTILE_RANGE 74.5 • n=115 Participants
|
|
Triglycerides
|
113.5 mg/dL
INTER_QUARTILE_RANGE 74.7 • n=5 Participants
|
118.0 mg/dL
INTER_QUARTILE_RANGE 83.4 • n=7 Participants
|
112.5 mg/dL
INTER_QUARTILE_RANGE 64.9 • n=5 Participants
|
116.5 mg/dL
INTER_QUARTILE_RANGE 52.4 • n=4 Participants
|
112.0 mg/dL
INTER_QUARTILE_RANGE 62.6 • n=21 Participants
|
119.0 mg/dL
INTER_QUARTILE_RANGE 59.1 • n=10 Participants
|
115.3 mg/dL
INTER_QUARTILE_RANGE 65.5 • n=115 Participants
|
|
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration
|
22.5 mg/dL
INTER_QUARTILE_RANGE 13.2 • n=5 Participants
|
23.8 mg/dL
INTER_QUARTILE_RANGE 15.4 • n=7 Participants
|
22.5 mg/dL
INTER_QUARTILE_RANGE 12.4 • n=5 Participants
|
23.5 mg/dL
INTER_QUARTILE_RANGE 10.5 • n=4 Participants
|
22.5 mg/dL
INTER_QUARTILE_RANGE 11.5 • n=21 Participants
|
23.5 mg/dL
INTER_QUARTILE_RANGE 11.8 • n=10 Participants
|
23.0 mg/dL
INTER_QUARTILE_RANGE 12.4 • n=115 Participants
|
|
High-density Lipoprotein Cholesterol (HDL-C) Concentration
|
57.0 mg/dL
INTER_QUARTILE_RANGE 23.6 • n=5 Participants
|
54.0 mg/dL
INTER_QUARTILE_RANGE 17.8 • n=7 Participants
|
58.5 mg/dL
INTER_QUARTILE_RANGE 16.8 • n=5 Participants
|
53.5 mg/dL
INTER_QUARTILE_RANGE 18.5 • n=4 Participants
|
53.0 mg/dL
INTER_QUARTILE_RANGE 18.0 • n=21 Participants
|
56.5 mg/dL
INTER_QUARTILE_RANGE 18.0 • n=10 Participants
|
55.3 mg/dL
INTER_QUARTILE_RANGE 18.7 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
|
0.10 percent change
Standard Error 1.67
|
-1.34 percent change
Standard Error 1.54
|
-17.75 percent change
Standard Error 1.67
|
-18.57 percent change
Standard Error 1.56
|
-57.04 percent change
Standard Error 1.23
|
-56.12 percent change
Standard Error 1.12
|
PRIMARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-0.43 percent change
Standard Error 1.45
|
-1.41 percent change
Standard Error 1.37
|
-17.52 percent change
Standard Error 1.46
|
-19.12 percent change
Standard Error 1.39
|
-56.93 percent change
Standard Error 1.07
|
-58.81 percent change
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
1.2 mg/dL
Standard Error 2.3
|
0.0 mg/dL
Standard Error 2.1
|
-23.1 mg/dL
Standard Error 2.3
|
-25.9 mg/dL
Standard Error 2.1
|
-78.4 mg/dL
Standard Error 1.7
|
-81.9 mg/dL
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
1.9 mg/dL
Standard Error 2.5
|
-0.1 mg/dL
Standard Error 2.4
|
-23.4 mg/dL
Standard Error 2.5
|
-25.0 mg/dL
Standard Error 2.4
|
-78.4 mg/dL
Standard Error 1.9
|
-77.9 mg/dL
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
1.3 percentage of participants
Interval 0.2 to 7.2
|
2.8 percentage of participants
Interval 0.8 to 9.6
|
73.6 percentage of participants
Interval 65.7 to 80.2
|
71.3 percentage of participants
Interval 63.6 to 78.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
|
1.4 percentage of participants
Interval 0.3 to 7.8
|
0.0 percentage of participants
Interval 0.0 to 5.2
|
1.4 percentage of participants
Interval 0.3 to 7.7
|
1.4 percentage of participants
Interval 0.3 to 7.8
|
72.9 percentage of participants
Interval 64.8 to 79.8
|
65.4 percentage of participants
Interval 57.1 to 72.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
|
-1.41 percent change
Standard Error 1.34
|
1.32 percent change
Standard Error 1.24
|
-14.64 percent change
Standard Error 1.35
|
-16.48 percent change
Standard Error 1.25
|
-50.22 percent change
Standard Error 0.99
|
-51.96 percent change
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
-0.31 percent change
Standard Error 1.48
|
1.51 percent change
Standard Error 1.38
|
-14.89 percent change
Standard Error 1.47
|
-16.48 percent change
Standard Error 1.39
|
-50.12 percent change
Standard Error 1.08
|
-49.68 percent change
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
|
0.05 percent change
Standard Error 1.51
|
1.54 percent change
Standard Error 1.41
|
-13.47 percent change
Standard Error 1.52
|
-14.75 percent change
Standard Error 1.43
|
-47.04 percent change
Standard Error 1.12
|
-49.39 percent change
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
0.59 percent change
Standard Error 1.58
|
1.84 percent change
Standard Error 1.53
|
-13.17 percent change
Standard Error 1.58
|
-14.02 percent change
Standard Error 1.54
|
-47.21 percent change
Standard Error 1.17
|
-46.59 percent change
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12
|
0.44 percent change
Standard Error 1.29
|
6.42 percent change
Standard Error 1.50
|
-9.14 percent change
Standard Error 1.29
|
-11.90 percent change
Standard Error 1.51
|
-38.49 percent change
Standard Error 0.95
|
-39.41 percent change
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
|
1.18 percent change
Standard Error 1.39
|
7.02 percent change
Standard Error 1.67
|
-10.03 percent change
Standard Error 1.39
|
-12.34 percent change
Standard Error 1.68
|
-38.45 percent change
Standard Error 1.02
|
-37.65 percent change
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
|
1.01 percent change
Standard Error 1.69
|
3.85 percent change
Standard Error 1.77
|
-13.39 percent change
Standard Error 1.69
|
-14.49 percent change
Standard Error 1.79
|
-48.12 percent change
Standard Error 1.25
|
-51.10 percent change
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
|
1.12 percent change
Standard Error 1.77
|
4.51 percent change
Standard Error 1.90
|
-12.69 percent change
Standard Error 1.77
|
-14.29 percent change
Standard Error 1.92
|
-48.45 percent change
Standard Error 1.31
|
-48.26 percent change
Standard Error 1.39
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
|
0.12 percent change
Inter-Quartile Range 2.72 • Interval -11.11 to 11.5
|
0.00 percent change
Inter-Quartile Range 2.96 • Interval -11.82 to 8.33
|
0.00 percent change
Inter-Quartile Range 2.72 • Interval -9.6 to 10.31
|
-2.08 percent change
Inter-Quartile Range 3.01 • Interval -18.18 to 5.56
|
-18.37 percent change
Inter-Quartile Range 2.02 • Interval -37.5 to 0.0
|
-19.24 percent change
Inter-Quartile Range 2.17 • Interval -38.8 to -4.79
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at Week 12
|
0.00 percent change
Inter-Quartile Range 2.75 • Interval -8.51 to 17.5
|
0.00 percent change
Inter-Quartile Range 3.26 • Interval -10.53 to 8.11
|
0.00 percent change
Inter-Quartile Range 2.75 • Interval -9.09 to 12.5
|
-2.05 percent change
Inter-Quartile Range 3.28 • Interval -17.19 to 8.33
|
-20.41 percent change
Inter-Quartile Range 2.04 • Interval -39.53 to 0.0
|
-17.82 percent change
Inter-Quartile Range 2.39 • Interval -38.46 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
|
-3.89 percent change
Inter-Quartile Range 3.64 • Interval -18.85 to 11.24
|
4.89 percent change
Inter-Quartile Range 4.02 • Interval -12.71 to 31.65
|
-1.46 percent change
Inter-Quartile Range 3.60 • Interval -15.03 to 18.41
|
-3.97 percent change
Inter-Quartile Range 4.04 • Interval -17.65 to 10.38
|
-9.16 percent change
Inter-Quartile Range 2.65 • Interval -24.19 to 11.03
|
-15.71 percent change
Inter-Quartile Range 2.92 • Interval -28.2 to 6.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
-1.91 percent change
Inter-Quartile Range 3.13 • Interval -18.58 to 11.46
|
2.01 percent change
Inter-Quartile Range 3.86 • Interval -16.62 to 33.83
|
0.00 percent change
Inter-Quartile Range 3.15 • Interval -13.26 to 17.54
|
-2.41 percent change
Inter-Quartile Range 3.89 • Interval -19.34 to 12.86
|
-8.14 percent change
Inter-Quartile Range 2.31 • Interval -26.14 to 10.13
|
-15.64 percent change
Inter-Quartile Range 2.78 • Interval -30.03 to 1.53
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
|
-3.81 percent change
Inter-Quartile Range 3.09 • Interval -19.16 to 9.97
|
4.22 percent change
Inter-Quartile Range 3.70 • Interval -13.6 to 27.91
|
-2.69 percent change
Inter-Quartile Range 3.12 • Interval -16.54 to 16.67
|
-3.33 percent change
Inter-Quartile Range 3.69 • Interval -20.0 to 9.52
|
-8.40 percent change
Inter-Quartile Range 2.28 • Interval -25.43 to 10.91
|
-16.17 percent change
Inter-Quartile Range 2.65 • Interval -28.0 to 5.52
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Ful analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in VLDL-C at Week 12
|
-1.58 percent change
Inter-Quartile Range 3.67 • Interval -20.0 to 10.53
|
0.00 percent change
Inter-Quartile Range 3.93 • Interval -16.67 to 33.33
|
-0.94 percent change
Inter-Quartile Range 3.65 • Interval -12.32 to 12.93
|
-3.61 percent change
Inter-Quartile Range 3.87 • Interval -19.23 to 14.29
|
-9.52 percent change
Inter-Quartile Range 2.64 • Interval -26.83 to 10.34
|
-16.33 percent change
Inter-Quartile Range 2.80 • Interval -30.73 to 2.51
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
|
-1.64 percent change
Inter-Quartile Range 1.26 • Interval -8.41 to 5.03
|
-4.67 percent change
Inter-Quartile Range 1.32 • Interval -10.63 to -0.57
|
-0.92 percent change
Inter-Quartile Range 1.27 • Interval -10.11 to 7.29
|
0.00 percent change
Inter-Quartile Range 1.33 • Interval -6.98 to 8.68
|
3.89 percent change
Inter-Quartile Range 0.93 • Interval -1.35 to 11.55
|
3.81 percent change
Inter-Quartile Range 0.95 • Interval -2.56 to 11.86
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Placebo Q2W
n=76 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 Participants
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12
|
-1.15 percent change
Inter-Quartile Range 1.43 • Interval -9.09 to 6.06
|
-5.27 percent change
Inter-Quartile Range 1.40 • Interval -11.3 to 2.33
|
-2.79 percent change
Inter-Quartile Range 1.42 • Interval -8.57 to 8.74
|
-1.47 percent change
Inter-Quartile Range 1.41 • Interval -6.67 to 8.2
|
4.76 percent change
Inter-Quartile Range 1.05 • Interval -2.86 to 12.82
|
4.06 percent change
Inter-Quartile Range 1.01 • Interval -2.68 to 11.15
|
Adverse Events
Placebo Q2W
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo QM
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Ezetimibe (Q2W)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ezetimibe (QM)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Evolocumab Q2W
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Evolocumab QM
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=76 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 participants at risk
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 participants at risk
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.65%
1/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.65%
1/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.65%
1/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.65%
1/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.65%
1/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo Q2W
n=76 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
|
Placebo QM
n=78 participants at risk
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
|
Ezetimibe (Q2W)
n=77 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=77 participants at risk
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=153 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=153 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
5/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
4/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
5/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
4/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
3/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
3/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
3.9%
3/76 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
4/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
5/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
5/153 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER