Trial Outcomes & Findings for A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol (NCT NCT02227784)
NCT ID: NCT02227784
Last Updated: 2019-10-08
Results Overview
Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
366 participants
Primary outcome timeframe
Baseline, 3 Months
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
Atorvastatin + Evacetrapib
Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Evacetrapib Open-Label (OLE)
Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|---|
|
Double-Blind Phase
STARTED
|
123
|
54
|
62
|
127
|
0
|
|
Double-Blind Phase
COMPLETED
|
83
|
36
|
41
|
88
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
40
|
18
|
21
|
39
|
0
|
|
Open-Label Extension Phase (OLE)
STARTED
|
0
|
0
|
0
|
0
|
248
|
|
Open-Label Extension Phase (OLE)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
247
|
|
Open-Label Extension Phase (OLE)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Extension Phase (OLE)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
248
|
Reasons for withdrawal
| Measure |
Atorvastatin + Evacetrapib
Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Evacetrapib Open-Label (OLE)
Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|---|
|
Double-Blind Phase
Adverse Event
|
3
|
2
|
1
|
3
|
0
|
|
Double-Blind Phase
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
|
Double-Blind Phase
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
|
Double-Blind Phase
Sponsor Decision
|
34
|
15
|
14
|
32
|
0
|
|
Double-Blind Phase
Withdrawal by Subject
|
2
|
1
|
5
|
2
|
0
|
|
Open-Label Extension Phase (OLE)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Phase (OLE)
Death
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Phase (OLE)
Sponsor Decision
|
0
|
0
|
0
|
0
|
243
|
|
Open-Label Extension Phase (OLE)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
Baseline characteristics by cohort
| Measure |
Atorvastatin + Evacetrapib
n=123 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=54 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=62 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=127 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
62.7 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
61.7 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
64.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 9.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
124 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
242 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
328 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
297 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
123 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
366 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable LDL-C data
Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
|
-33.44 percent
Interval -34.47 to -32.41
|
0.04 percent
Interval -1.01 to 1.09
|
-6.19 percent
Interval -7.24 to -5.15
|
-27.30 percent
Interval -28.33 to -26.27
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable HDL-C data.
Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
|
125.39 percent
Interval 124.37 to 126.4
|
0.11 percent
Interval -0.92 to 1.13
|
-6.10 percent
Interval -7.12 to -5.07
|
-2.18 percent
Interval -3.2 to -1.17
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants with evaluable apoAI data.
Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
|
46.08 percent
Interval 45.07 to 47.09
|
-0.27 percent
Interval -1.29 to 0.76
|
-6.14 percent
Interval -7.16 to -5.12
|
-2.36 percent
Interval -3.38 to -1.35
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable non-HDL-C data.
Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Non-HDL-C
|
-31.42 percent
Interval -32.44 to -30.4
|
-4.95 percent
Interval -5.98 to -3.92
|
-9.40 percent
Interval -10.44 to -8.37
|
-24.37 percent
Interval -25.4 to -23.35
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable apoB data.
Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
|
-22.96 percent
Interval -23.98 to -22.96
|
0.21 percent
Interval -0.82 to 1.24
|
-6.54 percent
Interval -7.56 to -5.51
|
-18.84 percent
Interval -19.86 to -17.82
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable cholesterol efflux capacity
Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
|
35.09 percent
Interval 34.07 to 36.11
|
-2.96 percent
Interval -3.99 to -1.93
|
-7.03 percent
Interval -8.06 to -6.0
|
-4.55 percent
Interval -5.57 to -3.53
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who had evaluable Lp(a) data.
Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Atorvastatin + Evacetrapib
n=86 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg
n=44 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg
n=40 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe
n=91 Participants
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
|
-28.73 percent
Interval -29.77 to 27.69
|
4.45 percent
Interval 3.4 to 5.5
|
3.90 percent
Interval 2.86 to 4.95
|
13.42 percent
Interval 12.39 to 14.45
|
Adverse Events
Atorvastatin + Evacetrapib Double-Blind (DB)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Atorvastatin 40 mg DB
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Atorvastatin 80 mg DB
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Atorvastatin + Ezetimibe DB
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Atorvastatin + Evacetrapib Open-Label (OLE)
Serious events: 11 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin + Evacetrapib Double-Blind (DB)
n=123 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg DB
n=54 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg DB
n=62 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe DB
n=127 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Evacetrapib Open-Label (OLE)
n=247 participants at risk
Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
1/62 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
1/123 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
General disorders
Chest discomfort
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
General disorders
Chest pain
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
1/62 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
1/62 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.79%
1/127 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.79%
1/127 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.81%
1/123 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Balance disorder
|
0.81%
1/123 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
1/62 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/127
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.40%
1/247 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/123
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/54
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/62
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.79%
1/127 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
0.00%
0/247
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
Other adverse events
| Measure |
Atorvastatin + Evacetrapib Double-Blind (DB)
n=123 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 40 mg DB
n=54 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin 80 mg DB
n=62 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Ezetimibe DB
n=127 participants at risk
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
Atorvastatin + Evacetrapib Open-Label (OLE)
n=247 participants at risk
Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
5/123 • Number of events 5
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
7.4%
4/54 • Number of events 4
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
1/62 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
2.4%
3/127 • Number of events 3
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
4/247 • Number of events 4
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/123 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.9%
1/54 • Number of events 1
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
6.5%
4/62 • Number of events 5
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
1.6%
2/127 • Number of events 2
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
2.0%
5/247 • Number of events 5
248 randomized participants from the double-blind phase moved to open-label phase but 1 participant did not receive drug. 247 randomized participants who moved to open-label phase that received drug are part of the safety population.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60