ACCENTUATE: A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02227784
• Collaborator: (none)
• Enrollment: 366
• Locations: 64
• Arms: 4
• Duration (Months): 14
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Drug: Evacetrapib; Drug: Atorvastatin; Drug: Ezetimibe; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 366 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Evacetrapib; Administered orally; Other Names: LY2484595 ; Drug: Atorvastatin; Administered orally; Drug: Placebo; Administered orally
Active Comparator: 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.	Drug: Atorvastatin; Administered orally; Drug: Placebo; Administered orally
Active Comparator: 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.	Drug: Atorvastatin; Administered orally; Drug: Ezetimibe; Administered orally; Drug: Placebo; Administered orally
Active Comparator: 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.	Drug: Atorvastatin; Administered orally; Drug: Placebo; Administered orally

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) [Baseline, 3 Months]

   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.

Secondary Outcome Measures

1. Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) [Baseline, 3 Months]

   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.

2. Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI) [Baseline, 3 Months]

   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.

3. Percent Change From Baseline to 3 Months in Non-HDL-C [Baseline, 3 Months]

   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.

4. Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB) [Baseline, 3 Months]

   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.

5. Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity [Baseline, 3 Months]

   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.

6. Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a]) [Baseline, 3 Months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening

• Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL

• Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)

• Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

Exclusion Criteria:

• Have a hemoglobin A1c (HbA1c) >9.5%

• New York Heart Association (NYHA) class III or IV congestive heart failure

• History of either a transient ischemic stroke or ischemic stroke <30 days

• History of acute coronary syndrome (ACS) <30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC	Huntsville	Alabama	United States	35801
2	Desert Clinical Research	Mesa	Arizona	United States	85213
3	Central Phoenix Med Clinic LLC	Phoenix	Arizona	United States	85020
4	Advanced Clinical Research	Carmichael	California	United States	95608
5	Tooraj Joseph Raoof M.D., Inc.	Encino	California	United States	91436
6	Irvine Clinical Research Center	Irvine	California	United States	92618
7	VA Long Beach Healthcare System	Long Beach	California	United States	90822
8	Rancho Cucamonga Clinical	Rancho Cucamonga	California	United States	91730
9	Encompass Clinical Research	Spring Valley	California	United States	91978
10	University Clinical Investigators, Inc.	Tustin	California	United States	92780
11	Diablo Clinical Research	Walnut Creek	California	United States	94598
12	University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045-2517
13	Cardiac Research	Colorado Springs	Colorado	United States	80909
14	ZASA Clinical Research	Boynton Beach	Florida	United States	33472
15	Cardiology Research Assoc.	Daytona Beach	Florida	United States	32117
16	Avail Clinical Research LLC	DeLand	Florida	United States	32720
17	Alan Graff, MD, PA	Fort Lauderdale	Florida	United States	33308
18	Nature Coast Clinical Research, LLC	Inverness	Florida	United States	34452
19	Suncoast Research Group, LLC	Miami	Florida	United States	33135
20	Progressive Medical Research	Port Orange	Florida	United States	32127
21	Cardiology Partners Clinical Research Institute, LLC	Wellington	Florida	United States	33449
22	Georgia Heart Specialists	Covington	Georgia	United States	30014
23	United Osteoporosis Center	Gainesville	Georgia	United States	30501
24	East West Medical Institute	Honolulu	Hawaii	United States	96814
25	Solaris Clinical Research	Meridian	Idaho	United States	83646
26	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois	United States	60005
27	Cedar-Crosse Research Center	Chicago	Illinois	United States	60607
28	Midwest CRC	Crystal Lake	Illinois	United States	60012
29	Indiana Heart Physicians Inc	Indianapolis	Indiana	United States	46237
30	Midwest Institute for Clinical Research	Indianapolis	Indiana	United States	46260
31	Hutchinson Clinic	Hutchinson	Kansas	United States	67502
32	Community Medical Associates	Louisville	Kentucky	United States	40205
33	Grace Research	Bossier City	Louisiana	United States	71111
34	Maryland Cardiovascular Specialists	Baltimore	Maryland	United States	21229
35	Overlea Personal Physicians	Baltimore	Maryland	United States	21236
36	Cape Cod Research Institute	Hyannis	Massachusetts	United States	02601
37	ActivMed Practices & Research, Inc	Methuen	Massachusetts	United States	01844
38	Medex Healthcare Research, Inc.	Saint Louis	Missouri	United States	63117
39	Palm Research Center	Las Vegas	Nevada	United States	89128
40	Heart and Vascular Center of New Brunswick LLC	Somerset	New Jersey	United States	08873
41	Medex Healthcare Research, Inc.	New York	New York	United States	10036
42	Saratoga Clinical Research LLC	Saratoga Springs	New York	United States	12866
43	Buffalo Cardiology and Pulmonary Associates, P.C.	Williamsville	New York	United States	14221
44	Asheville Cardiology Associates	Asheville	North Carolina	United States	28803
45	Metrolina Internal Medicine, P.A.	Charlotte	North Carolina	United States	28204
46	High Point Clinical Trials Center	High Point	North Carolina	United States	27265
47	Boice Willis Clinic, PA	Rocky Mount	North Carolina	United States	27804
48	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
49	Lillestol Research LLC	Fargo	North Dakota	United States	58103
50	Aventiv Research	Columbus	Ohio	United States	43213
51	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma	United States	73135
52	Portland Preventive Cardiology, LLC	Portland	Oregon	United States	97225
53	Partners in Clinical Research	Cumberland	Rhode Island	United States	02864
54	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina	United States	29464
55	Black Hills Cardiovascular Research Group	Rapid City	South Dakota	United States	57701
56	Holston Medical Group Clinical Research	Kingsport	Tennessee	United States	37660
57	Northwest Houston Heart Center	Tomball	Texas	United States	77375-4536
58	National Clinical Research - Richmond	Richmond	Virginia	United States	23294
59	Northwest Clinical Research Center	Bellevue	Washington	United States	98007-4209
60	Kootenai Heart Clinics, LLC	Spokane	Washington	United States	99204
61	Clinical Investigation Specialists Inc	Kenosha	Wisconsin	United States	53142
62	Research and Cardiovascular Corp.	Ponce		Puerto Rico	00717-1322
63	Clinical Research Puerto Rico, Inc.	San Juan		Puerto Rico	00909
64	GCM Medical Group PSC	San Juan		Puerto Rico	00909

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02227784
• Other Study ID Numbers: 14502; I1V-MC-EIBH
• First Posted: Aug 28, 2014
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Atorvastatin; Ezetimibe; Evacetrapib

Study Results

Participant Flow

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe	Atorvastatin + Evacetrapib Open-Label (OLE)
Arm/Group Description	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 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 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 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.	Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
Period Title: Double-Blind Phase
STARTED	123	54	62	127	0
COMPLETED	83	36	41	88	0
NOT COMPLETED	40	18	21	39	0
Period Title: Double-Blind Phase
STARTED	0	0	0	0	248
Received at Least 1 Dose of Study Drug	0	0	0	0	247
COMPLETED	0	0	0	0	0
NOT COMPLETED	0	0	0	0	248

Baseline Characteristics

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe	Total
Arm/Group Description	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 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 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 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 of all reporting groups
Overall Participants	123	54	62	127	366
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (8.7)	62.7 (9.3)	61.7 (10.2)	64.7 (8.9)	63.4 (9.2)
Sex: Female, Male (Count of Participants)
Female	38 30.9%	15 27.8%	18 29%	53 41.7%	124 33.9%
Male	85 69.1%	39 72.2%	44 71%	74 58.3%	242 66.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 10.6%	3 5.6%	9 14.5%	13 10.2%	38 10.4%
Not Hispanic or Latino	110 89.4%	51 94.4%	53 85.5%	114 89.8%	328 89.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 1.6%	1 0.8%	2 0.5%
Asian	4 3.3%	1 1.9%	0 0%	1 0.8%	6 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	19 15.4%	8 14.8%	15 24.2%	14 11%	56 15.3%
White	97 78.9%	44 81.5%	46 74.2%	110 86.6%	297 81.1%
More than one race	3 2.4%	1 1.9%	0 0%	1 0.8%	5 1.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	123 100%	54 100%	62 100%	127 100%	366 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable LDL-C data

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	-33.44	0.04	-6.19	-27.30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-33.48
	Confidence Interval	(2-Sided) 95%; -44.4 to -23.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-27.24
	Confidence Interval	(2-Sided) 95%; -36.6 to -18.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-6.14
	Confidence Interval	(2-Sided) 95%; -12.2 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable HDL-C data.

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	125.39	0.11	-6.10	-2.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	125.28
	Confidence Interval	(2-Sided) 95%; 117.1 to 133.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	131.48
	Confidence Interval	(2-Sided) 95%; 123.5 to 139.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	127.57
	Confidence Interval	(2-Sided) 95%; 120.1 to 135.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants with evaluable apoAI data.

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	46.08	-0.27	-6.14	-2.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	46.35
	Confidence Interval	(2-Sided) 95%; 40.79 to 51.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	52.22
	Confidence Interval	(2-Sided) 95%; 47.12 to 57.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	48.44
	Confidence Interval	(2-Sided) 95%; 43.82 to 52.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in Non-HDL-C
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable non-HDL-C data.

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	-31.42	-4.95	-9.40	-24.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-26.47
	Confidence Interval	(2-Sided) 95%; -33.4 to -20.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-22.02
	Confidence Interval	(2-Sided) 95%; -28.4 to -15.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-7.05
	Confidence Interval	(2-Sided) 95%; -11.5 to -2.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable apoB data.

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	-22.96	0.21	-6.54	-18.84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-23.16
	Confidence Interval	(2-Sided) 95%; -30.00 to -16.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-16.42
	Confidence Interval	(2-Sided) 95%; -22.3 to -10.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-4.11
	Confidence Interval	(2-Sided) 95%; -8.47 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable cholesterol efflux capacity

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin + Ezetimibe	Atorvastatin 80 mg
Arm/Group Description	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 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 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 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.
Measure Participants	86	40	44	91
Median (95% Confidence Interval) [percent]	35.09	-2.96	-7.03	-4.55

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	38.05
	Confidence Interval	(2-Sided) 95%; 30.17 to 45.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	42.12
	Confidence Interval	(2-Sided) 95%; 34.29 to 49.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	39.64
	Confidence Interval	(2-Sided) 95%; 33.20 to 46.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
Description	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.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable Lp(a) data.

Arm/Group Title	Atorvastatin + Evacetrapib	Atorvastatin 40 mg	Atorvastatin 80 mg	Atorvastatin + Ezetimibe
Arm/Group Description	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 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 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 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.
Measure Participants	86	44	40	91
Median (95% Confidence Interval) [percent]	-28.73	4.45	3.90	13.42

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 40 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-33.18
	Confidence Interval	(2-Sided) 95%; -44.9 to -22.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin 80 mg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-32.63
	Confidence Interval	(2-Sided) 95%; -44.0 to -21.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Atorvastatin + Evacetrapib, Atorvastatin + Ezetimibe
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-42.15
	Confidence Interval	(2-Sided) 95%; -50.9 to -33.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Atorvastatin + Evacetrapib Double-Blind (DB)		Atorvastatin 40 mg DB		Atorvastatin 80 mg DB		Atorvastatin + Ezetimibe DB		Atorvastatin + Evacetrapib Open-Label (OLE)
Arm/Group Description	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 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 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 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.		Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
All Cause Mortality
	Atorvastatin + Evacetrapib Double-Blind (DB)		Atorvastatin 40 mg DB		Atorvastatin 80 mg DB		Atorvastatin + Ezetimibe DB		Atorvastatin + Evacetrapib Open-Label (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin + Evacetrapib Double-Blind (DB)		Atorvastatin 40 mg DB		Atorvastatin 80 mg DB		Atorvastatin + Ezetimibe DB		Atorvastatin + Evacetrapib Open-Label (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/123 (1.6%)		3/54 (5.6%)		3/62 (4.8%)		3/127 (2.4%)		11/247 (4.5%)
Cardiac disorders
Coronary artery disease	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Myocardial infarction	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Gastrointestinal disorders
Vomiting	1/123 (0.8%)	1	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
General disorders
Chest discomfort	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Chest pain	0/123 (0%)	0	0/54 (0%)	0	1/62 (1.6%)	1	0/127 (0%)	0	0/247 (0%)	0
Non-cardiac chest pain	0/123 (0%)	0	0/54 (0%)	0	1/62 (1.6%)	1	0/127 (0%)	0	1/247 (0.4%)	1
Infections and infestations
Chronic sinusitis	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Pyelonephritis	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	1/127 (0.8%)	1	0/247 (0%)	0
Urinary tract infection	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Urosepsis	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Injury, poisoning and procedural complications
Accidental overdose	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Ductal adenocarcinoma of pancreas	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	1/127 (0.8%)	1	0/247 (0%)	0
Lung adenocarcinoma	1/123 (0.8%)	1	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Nervous system disorders
Balance disorder	1/123 (0.8%)	1	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Carotid artery stenosis	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Cerebrovascular accident	0/123 (0%)	0	0/54 (0%)	0	1/62 (1.6%)	1	0/127 (0%)	0	0/247 (0%)	0
Cervical myelopathy	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Dizziness	1/123 (0.8%)	1	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Hypoaesthesia	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Ischaemic stroke	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Transient ischaemic attack	0/123 (0%)	0	0/54 (0%)	0	1/62 (1.6%)	1	0/127 (0%)	0	0/247 (0%)	0
Psychiatric disorders
Suicidal ideation	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Chronic obstructive pulmonary disease	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Pulmonary embolism	0/123 (0%)	0	1/54 (1.9%)	1	0/62 (0%)	0	0/127 (0%)	0	0/247 (0%)	0
Surgical and medical procedures
Implantable defibrillator replacement	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	0/127 (0%)	0	1/247 (0.4%)	1
Vascular disorders
Hypotension	0/123 (0%)	0	0/54 (0%)	0	0/62 (0%)	0	1/127 (0.8%)	1	0/247 (0%)	0
Other (Not Including Serious) Adverse Events
	Atorvastatin + Evacetrapib Double-Blind (DB)		Atorvastatin 40 mg DB		Atorvastatin 80 mg DB		Atorvastatin + Ezetimibe DB		Atorvastatin + Evacetrapib Open-Label (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/123 (4.9%)		5/54 (9.3%)		4/62 (6.5%)		5/127 (3.9%)		9/247 (3.6%)
Gastrointestinal disorders
Diarrhoea	5/123 (4.1%)	5	4/54 (7.4%)	4	1/62 (1.6%)	1	3/127 (2.4%)	3	4/247 (1.6%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	1/123 (0.8%)	1	1/54 (1.9%)	1	4/62 (6.5%)	5	2/127 (1.6%)	2	5/247 (2%)	5

Limitations/Caveats

Early termination was due to program termination.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.