Trial Outcomes & Findings for A Study of LY2484595 in Japanese Subjects (NCT NCT01375075)
NCT ID: NCT01375075
Last Updated: 2018-10-25
Results Overview
Percent change from baseline = 100\*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-10-25
Participant Flow
Prior to randomization, participants stopped lipid-related concomitant medications and started a diet therapy in accordance with the Japan Atherosclerosis Society guidelines for diagnosis and prevention of atherosclerotic cardiovascular disease.
Participant milestones
| Measure |
30 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
27
|
28
|
27
|
28
|
|
Overall Study
Received at Least One Dose of Study Drug
|
27
|
28
|
27
|
28
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
27
|
24
|
27
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
30 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
1
|
0
|
1
|
|
Overall Study
Entry Criterion Not Met
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2484595 in Japanese Subjects
Baseline characteristics by cohort
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet
|
100 mg LY2484595
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 11.94 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 9.63 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 8.76 • n=21 Participants
|
50.0 years
STANDARD_DEVIATION 10.01 • n=8 Participants
|
49.2 years
STANDARD_DEVIATION 9.88 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
110 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
165 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
165 Participants
n=8 Participants
|
|
Weight
|
68.5 kilograms (kg)
STANDARD_DEVIATION 14.04 • n=5 Participants
|
65.9 kilograms (kg)
STANDARD_DEVIATION 11.58 • n=7 Participants
|
68.5 kilograms (kg)
STANDARD_DEVIATION 15.71 • n=5 Participants
|
69.3 kilograms (kg)
STANDARD_DEVIATION 13.51 • n=4 Participants
|
67.4 kilograms (kg)
STANDARD_DEVIATION 12.77 • n=21 Participants
|
70.3 kilograms (kg)
STANDARD_DEVIATION 18.33 • n=8 Participants
|
68.3 kilograms (kg)
STANDARD_DEVIATION 14.34 • n=8 Participants
|
|
Height
|
165.1 centimeters (cm)
STANDARD_DEVIATION 9.48 • n=5 Participants
|
165.4 centimeters (cm)
STANDARD_DEVIATION 9.95 • n=7 Participants
|
166.5 centimeters (cm)
STANDARD_DEVIATION 9.27 • n=5 Participants
|
165.6 centimeters (cm)
STANDARD_DEVIATION 8.56 • n=4 Participants
|
166.7 centimeters (cm)
STANDARD_DEVIATION 6.76 • n=21 Participants
|
165.2 centimeters (cm)
STANDARD_DEVIATION 8.34 • n=8 Participants
|
165.7 centimeters (cm)
STANDARD_DEVIATION 8.68 • n=8 Participants
|
|
Body Mass Index (BMI)
|
24.9 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.38 • n=5 Participants
|
24.0 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.15 • n=7 Participants
|
24.5 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 4.10 • n=5 Participants
|
25.1 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.70 • n=4 Participants
|
24.1 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.35 • n=21 Participants
|
25.5 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 5.49 • n=8 Participants
|
24.7 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.93 • n=8 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
143.9 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 24.02 • n=5 Participants
|
143.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 23.05 • n=7 Participants
|
142.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 30.16 • n=5 Participants
|
140.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 27.37 • n=4 Participants
|
134.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 31.78 • n=21 Participants
|
139.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 19.84 • n=8 Participants
|
140.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 26.12 • n=8 Participants
|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
50.2 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 12.88 • n=5 Participants
|
52.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 16.15 • n=7 Participants
|
49.2 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 11.41 • n=5 Participants
|
50.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 14.39 • n=4 Participants
|
48.9 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 13.70 • n=21 Participants
|
51.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 14.47 • n=8 Participants
|
50.5 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 13.77 • n=8 Participants
|
|
Fasting Triglycerides (TG)
|
156.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 74.31 • n=5 Participants
|
133.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 64.75 • n=7 Participants
|
145.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 79.14 • n=5 Participants
|
138.9 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 64.56 • n=4 Participants
|
143.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 60.02 • n=21 Participants
|
144.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 75.32 • n=8 Participants
|
143.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 69.27 • n=8 Participants
|
|
Systolic Blood Pressure
|
118.8 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 11.75 • n=5 Participants
|
117.7 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 12.41 • n=7 Participants
|
118.4 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 12.61 • n=5 Participants
|
119.5 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 11.67 • n=4 Participants
|
119.6 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 9.82 • n=21 Participants
|
116.9 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 13.31 • n=8 Participants
|
118.5 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 11.84 • n=8 Participants
|
|
Diastolic Blood Pressure
|
73.7 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 7.32 • n=5 Participants
|
74.0 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 9.57 • n=7 Participants
|
74.3 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 9.77 • n=5 Participants
|
75.1 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 7.32 • n=4 Participants
|
75.4 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 7.58 • n=21 Participants
|
71.8 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 8.52 • n=8 Participants
|
74.0 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 8.37 • n=8 Participants
|
|
Pulse Rate
|
68.4 beats per minute (bpm)
STANDARD_DEVIATION 8.90 • n=5 Participants
|
67.7 beats per minute (bpm)
STANDARD_DEVIATION 7.45 • n=7 Participants
|
68.2 beats per minute (bpm)
STANDARD_DEVIATION 10.41 • n=5 Participants
|
67.3 beats per minute (bpm)
STANDARD_DEVIATION 11.15 • n=4 Participants
|
68.4 beats per minute (bpm)
STANDARD_DEVIATION 8.14 • n=21 Participants
|
72.4 beats per minute (bpm)
STANDARD_DEVIATION 8.90 • n=8 Participants
|
68.8 beats per minute (bpm)
STANDARD_DEVIATION 9.26 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement \[modified intent-to-treat (mITT) population\], and also completed the Week 12 visit.
Percent change from baseline = 100\*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=25 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
LDL-C
|
-14.23 percent change
Standard Error 3.46
|
-22.13 percent change
Standard Error 3.43
|
-20.95 percent change
Standard Error 3.55
|
1.24 percent change
Standard Error 3.40
|
-37.66 percent change
Standard Error 3.44
|
-52.29 percent change
Standard Error 3.47
|
|
Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
HDL-C
|
82.22 percent change
Standard Error 8.97
|
123.35 percent change
Standard Error 8.92
|
143.56 percent change
Standard Error 9.16
|
8.00 percent change
Standard Error 8.83
|
17.35 percent change
Standard Error 8.91
|
120.60 percent change
Standard Error 8.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, and 8Population: All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline value of the response variable for the specified time frame.
Percent change from baseline = 100\*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement for HDL-C and a decrease in the percent change from baseline represents an improvement for LDL-C. LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
HDL-C, Week 2
|
75.30 percent change
Standard Error 6.44
|
108.21 percent change
Standard Error 6.45
|
122.60 percent change
Standard Error 6.44
|
-0.73 percent change
Standard Error 6.32
|
8.85 percent change
Standard Error 6.45
|
101.45 percent change
Standard Error 6.33
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
HDL-C, Week 4
|
77.94 percent change
Standard Error 7.62
|
122.68 percent change
Standard Error 7.63
|
147.22 percent change
Standard Error 7.72
|
2.09 percent change
Standard Error 7.53
|
10.87 percent change
Standard Error 7.62
|
117.04 percent change
Standard Error 7.49
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
HDL-C, Week 8
|
78.65 percent change
Standard Error 7.95
|
130.69 percent change
Standard Error 7.91
|
169.05 percent change
Standard Error 8.08
|
5.19 percent change
Standard Error 7.82
|
12.98 percent change
Standard Error 7.91
|
116.64 percent change
Standard Error 7.90
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
LDL-C, Week 2
|
-17.46 percent change
Standard Error 3.13
|
-27.50 percent change
Standard Error 3.14
|
-33.19 percent change
Standard Error 3.13
|
-2.14 percent change
Standard Error 3.07
|
-38.29 percent change
Standard Error 3.14
|
-55.74 percent change
Standard Error 3.04
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
LDL-C, Week 4
|
-13.32 percent change
Standard Error 3.14
|
-24.43 percent change
Standard Error 3.14
|
-29.25 percent change
Standard Error 3.18
|
2.84 percent change
Standard Error 3.10
|
-42.23 percent change
Standard Error 3.15
|
-52.62 percent change
Standard Error 3.08
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
LDL-C, Week 8
|
-12.50 percent change
Standard Error 3.39
|
-23.56 percent change
Standard Error 3.37
|
-25.48 percent change
Standard Error 3.45
|
0.24 percent change
Standard Error 3.33
|
-38.97 percent change
Standard Error 3.38
|
-51.23 percent change
Standard Error 3.38
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12 (predose and postdose), and Week 16Population: Participants who were administered LY2484595 or LY2484595 + Atorvastatin and had evaluable pharmacokinetic (PK) samples.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin
|
3110 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 32
|
8690 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 44
|
29400 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
8080 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication intent-to-treat (ITT) population.
All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (severity). Categories included high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination. High risk rashes included anaphylaxis, toxic epidermal necrolysis, Stevens Johnson Syndrome, Drug Reaction with Eosinophilia and System Symptoms (DRESS), urticaria/angioedema, vasculitis, erythroderma, and lupus-like reaction. All other rashes were considered low risk or not a relevant dermatosis per the Investigator's clinical opinion. A participant could be reported in multiple categories.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12
Low risk
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
1 events
|
|
The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12
High risk
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
|
The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12
Not a relevant dermatosis
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12
Insufficient documentation for determination
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline value of the response variable.
Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP). LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=25 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Blood Pressure
SBP
|
2.35 millimeters of mercury (mm Hg)
Standard Error 1.78
|
1.44 millimeters of mercury (mm Hg)
Standard Error 1.76
|
4.51 millimeters of mercury (mm Hg)
Standard Error 1.84
|
-1.39 millimeters of mercury (mm Hg)
Standard Error 1.75
|
2.59 millimeters of mercury (mm Hg)
Standard Error 1.76
|
2.04 millimeters of mercury (mm Hg)
Standard Error 1.80
|
|
Change From Baseline to 12 Weeks in Blood Pressure
DBP
|
1.46 millimeters of mercury (mm Hg)
Standard Error 1.07
|
0.02 millimeters of mercury (mm Hg)
Standard Error 1.05
|
2.51 millimeters of mercury (mm Hg)
Standard Error 1.10
|
0.68 millimeters of mercury (mm Hg)
Standard Error 1.05
|
1.49 millimeters of mercury (mm Hg)
Standard Error 1.05
|
0.51 millimeters of mercury (mm Hg)
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline aldosterone measurement.
LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=25 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=25 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=21 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=25 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=25 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=24 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Aldosterone
|
-0.40 nanograms per deciliter (ng/dL)
Standard Error 0.79
|
0.37 nanograms per deciliter (ng/dL)
Standard Error 0.79
|
0.59 nanograms per deciliter (ng/dL)
Standard Error 0.84
|
0.33 nanograms per deciliter (ng/dL)
Standard Error 0.79
|
0.95 nanograms per deciliter (ng/dL)
Standard Error 0.79
|
0.62 nanograms per deciliter (ng/dL)
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline plasma renin activity measurement.
LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=26 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=24 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Plasma Renin Activity
|
-0.32 nanograms per milliliter per hour
Standard Error 0.23
|
0.01 nanograms per milliliter per hour
Standard Error 0.24
|
-0.21 nanograms per milliliter per hour
Standard Error 0.23
|
-0.21 nanograms per milliliter per hour
Standard Error 0.23
|
-0.01 nanograms per milliliter per hour
Standard Error 0.23
|
-0.43 nanograms per milliliter per hour
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum sodium measurement.
LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=25 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Serum Sodium
|
-0.18 milliequivalents per liter (mEq/L)
Standard Error 0.31
|
-0.32 milliequivalents per liter (mEq/L)
Standard Error 0.30
|
-0.07 milliequivalents per liter (mEq/L)
Standard Error 0.32
|
-0.32 milliequivalents per liter (mEq/L)
Standard Error 0.30
|
0.35 milliequivalents per liter (mEq/L)
Standard Error 0.30
|
0.53 milliequivalents per liter (mEq/L)
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum bicarbonate measurement.
LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=24 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=25 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Serum Bicarbonate
|
0.63 milliequivalents per liter (mEq/L)
Standard Error 0.43
|
0.62 milliequivalents per liter (mEq/L)
Standard Error 0.43
|
0.62 milliequivalents per liter (mEq/L)
Standard Error 0.45
|
0.52 milliequivalents per liter (mEq/L)
Standard Error 0.43
|
0.62 milliequivalents per liter (mEq/L)
Standard Error 0.43
|
1.23 milliequivalents per liter (mEq/L)
Standard Error 0.44
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population).
Myopathy events were considered muscle-related treatment emergent adverse events (TEAEs) and liver injury events were considered hepatic disorder-related TEAEs reported per Medical Dictionary for Regulatory Activities (MedDRA). An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were newly occurring AEs or AEs worsening after first dose.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Number of Myopathy and Liver Injury Events
Gamma-glutamyltransferase increased
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Myopathy and Liver Injury Events
Blood creatine phosphokinase increased
|
0 events
|
1 events
|
0 events
|
0 events
|
1 events
|
0 events
|
|
Number of Myopathy and Liver Injury Events
Myalgia
|
0 events
|
1 events
|
0 events
|
0 events
|
1 events
|
0 events
|
|
Number of Myopathy and Liver Injury Events
Hepatic function abnormal
|
1 events
|
0 events
|
1 events
|
0 events
|
1 events
|
2 events
|
|
Number of Myopathy and Liver Injury Events
Alanine aminotransferase increased
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline hsCRP measurement.
LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP)
|
-0.03 milligrams per deciliter (mg/dL)
Standard Error 0.10
|
0.00 milligrams per deciliter (mg/dL)
Standard Error 0.10
|
0.13 milligrams per deciliter (mg/dL)
Standard Error 0.09
|
-0.01 milligrams per deciliter (mg/dL)
Standard Error 0.09
|
-0.03 milligrams per deciliter (mg/dL)
Standard Error 0.10
|
0.15 milligrams per deciliter (mg/dL)
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP activity measurement.
Plasma CETP activity assay employed a fluorometric method to determine the CETP transfer activity. Percent change from baseline = 100\*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement. LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=26 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=25 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
4 Weeks
|
-41.62 percent change in CETP activity
Standard Error 4.23
|
-75.26 percent change in CETP activity
Standard Error 4.30
|
-89.14 percent change in CETP activity
Standard Error 4.38
|
1.67 percent change in CETP activity
Standard Error 4.22
|
-1.33 percent change in CETP activity
Standard Error 4.22
|
-68.58 percent change in CETP activity
Standard Error 4.21
|
|
Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
8 Weeks
|
-39.91 percent change in CETP activity
Standard Error 4.47
|
-76.23 percent change in CETP activity
Standard Error 4.40
|
-90.97 percent change in CETP activity
Standard Error 4.57
|
2.70 percent change in CETP activity
Standard Error 4.32
|
-4.89 percent change in CETP activity
Standard Error 4.32
|
-79.90 percent change in CETP activity
Standard Error 4.60
|
|
Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
12 Weeks
|
-41.07 percent change in CETP activity
Standard Error 3.57
|
-73.86 percent change in CETP activity
Standard Error 3.55
|
-85.30 percent change in CETP activity
Standard Error 3.69
|
9.22 percent change in CETP activity
Standard Error 3.49
|
-5.69 percent change in CETP activity
Standard Error 3.54
|
-73.38 percent change in CETP activity
Standard Error 3.74
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP mass measurement.
Plasma CETP mass assay was a solid-phase enzyme-linked immunosorbent assay (ELISA) designated to measure human CETP mass which employed the quantitative enzyme immunoassay principle. An increase in plasma CETP mass represented an improvement. LS mean was adjusted for baseline value of the variable analyzed.
Outcome measures
| Measure |
30 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
|
100 mg LY2484595
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=25 Participants
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=27 Participants
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 Participants
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma CETP Mass
8 weeks
|
1.98 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
3.09 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
4.02 micrograms per milliliter (µg/mL)
Standard Error 0.22
|
0.10 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
-0.21 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
1.83 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
|
Change From Baseline in Plasma CETP Mass
12 weeks
|
1.95 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
2.96 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
3.36 micrograms per milliliter (µg/mL)
Standard Error 0.22
|
0.13 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
-0.19 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
1.95 micrograms per milliliter (µg/mL)
Standard Error 0.21
|
|
Change From Baseline in Plasma CETP Mass
4 weeks
|
1.88 micrograms per milliliter (µg/mL)
Standard Error 0.18
|
3.14 micrograms per milliliter (µg/mL)
Standard Error 0.18
|
3.54 micrograms per milliliter (µg/mL)
Standard Error 0.18
|
0.08 micrograms per milliliter (µg/mL)
Standard Error 0.18
|
-0.28 micrograms per milliliter (µg/mL)
Standard Error 0.18
|
1.94 micrograms per milliliter (µg/mL)
Standard Error 0.17
|
Adverse Events
30 mg LY2484595
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
100 mg LY2484595
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
500 mg LY2484595
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
10 mg Atorvastatin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
100 mg LY2484595 + 10 mg Atorvastatin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 mg LY2484595
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet
|
100 mg LY2484595
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
Other adverse events
| Measure |
30 mg LY2484595
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet
|
100 mg LY2484595
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
|
500 mg LY2484595
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets
|
Placebo
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule
|
10 mg Atorvastatin
n=27 participants at risk
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets
|
100 mg LY2484595 + 10 mg Atorvastatin
n=28 participants at risk
The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Eye disorders
Asthenopia
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
General disorders
Feeling hot
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
General disorders
Malaise
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Infections and infestations
Cellulitis
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
7.4%
2/27 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Impetigo
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Infections and infestations
Influenza
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
3/27 • Number of events 4
|
21.4%
6/28 • Number of events 6
|
11.1%
3/27 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
Infections and infestations
Pertussis
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Infections and infestations
Pharyngitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Infections and infestations
Respiratory tract infection
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Investigations
Eosinophil count increased
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 2
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/28
|
0.00%
0/27
|
3.6%
1/28 • Number of events 1
|
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