A Study of LY2484595 in Japanese Subjects

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01375075
• Collaborator: (none)
• Enrollment: 165
• Locations: 5
• Arms: 6
• Duration (Months): 9
• Patients Per Site: 33
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if 12 weeks of treatment with LY2484595 administered as a monotherapy will significantly increase high-density lipoprotein cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese participants.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias	Drug: LY2484595; Drug: Placebo; Drug: Atorvastatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Dose Response Study of LY2484595 in Japanese Subjects
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30 milligrams (mg) LY2484595 Administered orally once daily for 12 weeks	Drug: LY2484595; Administered orally; Drug: Placebo; Administered orally
Experimental: 100 mg LY2484595 Administered orally once daily for 12 weeks	Drug: LY2484595; Administered orally; Drug: Placebo; Administered orally
Experimental: 500 mg LY2484595 Administered orally once daily for 12 weeks	Drug: LY2484595; Administered orally; Drug: Placebo; Administered orally
Placebo Comparator: Placebo Administered orally once daily for 12 weeks	Drug: Placebo; Administered orally
Active Comparator: 10 mg Atorvastatin Administered orally once daily for 12 weeks	Drug: Placebo; Administered orally; Drug: Atorvastatin; Administered orally
Experimental: 100 mg LY2484595 + 10 mg Atorvastatin Administered orally once daily for 12 weeks	Drug: LY2484595; Administered orally; Drug: Placebo; Administered orally; Drug: Atorvastatin; Administered orally

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline and Week 12]

   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.

Secondary Outcome Measures

1. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin [Baseline, Weeks 2, 4, and 8]

   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.

2. Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin [Weeks 2, 4, 8, 12 (predose and postdose), and Week 16]

3. The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 [Baseline through Week 12]

   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.

4. Change From Baseline to 12 Weeks in Blood Pressure [Baseline and Week 12]

   Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP). LS mean was adjusted for baseline value of the variable analyzed.

5. Change From Baseline to 12 Weeks in Aldosterone [Baseline and Week 12]

   LS mean was adjusted for baseline value of the variable analyzed.

6. Change From Baseline to 12 Weeks in Plasma Renin Activity [Baseline and Week 12]

   LS mean was adjusted for baseline value of the variable analyzed.

7. Change From Baseline to 12 Weeks in Serum Sodium [Baseline and Week 12]

   LS mean was adjusted for baseline value of the variable analyzed.

8. Change From Baseline to 12 Weeks in Serum Bicarbonate [Baseline and Week 12]

   LS mean was adjusted for baseline value of the variable analyzed.

9. Number of Myopathy and Liver Injury Events [Baseline through Week 12]

   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.

10. Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) [Baseline and Week 12]

    LS mean was adjusted for baseline value of the variable analyzed.

11. Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity [Baseline, Weeks 4, 8, and 12]

    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.

12. Change From Baseline in Plasma CETP Mass [Baseline, Weeks 4, 8, and 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Have Low HDL-C or High LDL-C criteria as follows:

Low HDL lipid criteria:

• HDL-C <45 milligrams per deciliter (mg/dL) (men) and <50 mg/dL (women), and

• LDL-C according to Japan Atherosclerosis Society (JAS) guidelines as follows:

• LDL-C <190 mg/dL (0-1 risk factors)

• LDL-C <160 mg/dL (2 risk factors)

• LDL-C <130 mg/dL (3+ risk factors),and

• Fasting Triglycerides (TG) <400 mg/dL

or

High LDL-C lipid criteria:

• HDL-C <100 mg/dL, and

• LDL-C according to JAS guidelines as follows:

• LDL-C 100-190 mg/dL (0-1 risk factors)

• LDL-C 100-160 mg/dL (2 risk factors)

• LDL-C 100-130 mg/dL (3+ risk factors), and

• Fasting TG <400 mg/dL

Note: Subjects with diabetes regarded as 3+ risk factors

• Male subjects: Agree to use a reliable method of birth control during the study (and for 2 weeks following the last dose of study drug)

• Female subjects: 1) Women not of childbearing potential due to surgical sterilization (at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause. Menopausal women include women with either a) spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea [for example, oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators (SERMs), or chemotherapy] or b) spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 milli-international units per milliliter (mIU/mL). or, 2) Women of child bearing potential who test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study and for 2 weeks following the last dose of study drug

• Have given informed consent to participate in the study

Exclusion Criteria:

• At screening, are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Have participated within 90 days prior to screening in any clinical trials of cholesteryl ester transfer protein (CETP) inhibitors (e.g., anacetrapib or dalcetrapib)

• Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY2484595

• Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, or will not abide by the procedures and study restrictions

• Have recent history of any clinically significant rash, history of any clinically severe drug-related rash, history of a chronic skin disorder (such as psoriasis, eczema or urticaria), history of significant skin hypersensitivities to household or cosmetic products, or allergens per the investigator, or presence of widespread tattoos or other skin condition that limits the assessment for rashes. Subjects who develop any rash during the Diet Lead-in/Washout Phase cannot be randomized

• Have or have had any clinical manifestation of coronary heart disease (CHD), such as stable or unstable angina, acute coronary syndrome, myocardial infarction, or a coronary revascularization procedure including stent placement, symptomatic carotid artery disease or symptomatic peripheral arterial disease. Subjects with a diagnosis of abdominal aortic aneurysm are excluded from this study

• Have systolic blood pressure (SBP) >140 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >90 mm Hg as determined by the mean of 3 standardized measurements in the sitting position at randomization

• Have or have had documented hyperaldosteronism

• Have symptoms consistent with moderate or severe heart failure or are receiving treatment for symptomatic congestive heart failure (CHF) or known left ventricular ejection fraction (LVEF) <35%. The absence of LVEF measurement does not prohibit entry into this study

• Have one of the following abnormalities: QTc prolongation [Bazett's corrected QT interval (QTcB)] of >450 msec in male subjects or >470 msec in female subjects, or abnormally wide QRS complexes (resulting from bundle branch blocks, intraventricular conduction delays, or pacemakers) or atrial fibrillation on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long QT syndrome, previous history of ventricular tachycardia or unexplained syncope

• Have family history of long QT syndrome or sudden death likely secondary to ventricular arrhythmia

• Have active hepatobiliary disease, serologic evidence of past or active hepatitis B or C, or past or active gallbladder disease. Subjects who have been diagnosed with Gilbert syndrome or had a cholecystectomy greater than 90 days prior to screening can be included

• Have aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP), or total bilirubin >1.5 times the upper limit of normal (ULN)

• Have a history or presence of a chronic muscular or neuromuscular disease including prior rhabdomyolysis or drug-induced myopathy or an unexplained/documented elevation in creatine kinase (CK) ≥3 times the ULN

• Have a history of discontinuation from statin, change of statin, or a dose reduction of statin due to history of hypersensitivity, intolerance or adverse effect. Have a history of increased hepatic enzymes associated with use of an hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin)

• Have a history of hypersensitivity or intolerance to drug preparations containing cholesteryl ester transfer protein (CETP) inhibitors, including but not limited to torcetrapib, anacetrapib, or dalcetrapib

• Have a hemoglobin A1c ≥8.0%; or use, plan to use, or are likely to require insulin during the course of the study. Diabetic subjects on an antidiabetic agent with lipid modifying effects must be on a stable dose for at least 30 days prior to screening

• Have a serum creatinine ≥2 mg/dL, or nephrotic syndrome, end stage renal disease and use renal replacement therapy such as hemodialysis or peritoneal dialysis

• Have hemoglobin <10 grams per deciliter (g/dL) in women and <11 g/dL in men

• Have current uncontrolled active inflammatory condition or infection which in the opinion of the investigator would influence a subject's ability to complete the study

• Have thyroid-stimulating hormone (TSH) levels outside normal reference range. Subjects who are clinically euthyroid, on stable thyroid replacement therapy for 60 days prior to screening, and are anticipated to remain on this dose throughout the trial period are acceptable exceptions to this criterion

• Are women who are lactating

• Have planned or are likely to require major surgery requiring anesthesia or hospitalization during the course of the study

• Have chronic alcohol or drug abuse or dependency

• Are currently under suspicion of having cancer or have had a history of cancer in the past 2 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin

• Have history of human immunodeficiency virus (HIV) infection

• Have any other condition or abnormal laboratory value, which in the opinion of the investigator precludes the subject from providing informed consent

• Plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription or over-the-counter (OTC) medication or health foods with the intent to treat serum lipids (LDL-C, HDL-C, triglycerides) including but not limited to these classes of drugs: statin, ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA). Subjects taking probucol, fibrate or nicotinic agents within 8 weeks before screening are excluded from the study

• Are currently using, plan to use, or are likely to require during the course of the study systemic corticosteroids; or anabolic agents other than stable doses of estrogen, estrogen/progestin, or testosterone replacement therapy

• Are currently using, plan to use, or are likely to require during the course of the study, more than the occasional use (i.e., once every other week) of stimulant laxatives (e.g., bisacodyl), osmotic laxatives (e.g., milk of magnesia), or castor oil

• Use of any immunosuppressive therapy within 60 days prior to screening or are likely to require immunosuppressive therapy during the course of the study

• Have received treatment within 30 days prior to the time of study entry with any drug or drugs that have not received regulatory approval for any indication

• Have plans to adopt diets with aggressive carbohydrate restrictions for weight loss. Currently use, have used within 60 days prior to screening, or plan to use during the trial period prescriptions or OTC formulations intended for weight loss

• Are currently using, have used within 60 days prior to screening, plan to use, or are likely to require during the course of the study, drugs or foods that are inducers (including rifampin and carbamazepine) or moderate or strong inhibitors of cytochrome P450 3A (including, ketoconazole, erythromycin and grapefruit juice); or strong inhibitors of the organic anion transporter polypeptide 1B1 (OATP1B1) transporter (including cyclosporine and rifampin). The drugs used in topical preparations are acceptable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hyogo		Japan	660-0814
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kanagawa		Japan	231-0023
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kyoto		Japan	615-8125
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka		Japan	560-0005
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo		Japan	111-0052

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: NCT01375075
• Other Study ID Numbers: 13049; I1V-JE-EIAE
• First Posted: Jun 17, 2011
• Last Update Posted: Oct 25, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Dyslipidemias; Atorvastatin; Evacetrapib

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Period Title: Overall Study
STARTED	27	28	27	28	27	28
Received at Least One Dose of Study Drug	27	28	27	28	27	28
COMPLETED	26	27	24	27	27	25
NOT COMPLETED	1	1	3	1	0	3

Baseline Characteristics

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin	Total
Arm/Group Description	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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 of all reporting groups
Overall Participants	27	28	27	28	27	28	165
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.6 (10.95)	47.6 (11.94)	49.4 (8.10)	50.3 (9.63)	49.4 (8.76)	50.0 (10.01)	49.2 (9.88)
Sex: Female, Male (Count of Participants)
Female	8 29.6%	10 35.7%	9 33.3%	10 35.7%	8 29.6%	10 35.7%	55 33.3%
Male	19 70.4%	18 64.3%	18 66.7%	18 64.3%	19 70.4%	18 64.3%	110 66.7%
Race/Ethnicity, Customized (Count of Participants)
Japanese	27 100%	28 100%	27 100%	28 100%	27 100%	28 100%	165 100%
Region of Enrollment (Count of Participants)
Japan	27 100%	28 100%	27 100%	28 100%	27 100%	28 100%	165 100%
Weight (kilograms (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms (kg)]	68.5 (14.04)	65.9 (11.58)	68.5 (15.71)	69.3 (13.51)	67.4 (12.77)	70.3 (18.33)	68.3 (14.34)
Height (centimeters (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters (cm)]	165.1 (9.48)	165.4 (9.95)	166.5 (9.27)	165.6 (8.56)	166.7 (6.76)	165.2 (8.34)	165.7 (8.68)
Body Mass Index (BMI) (kilograms per square meter (kg/m²)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per square meter (kg/m²)]	24.9 (3.38)	24.0 (3.15)	24.5 (4.10)	25.1 (3.70)	24.1 (3.35)	25.5 (5.49)	24.7 (3.93)
Low-Density Lipoprotein Cholesterol (LDL-C) (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligrams per deciliter (mg/dL)]	143.9 (24.02)	143.6 (23.05)	142.6 (30.16)	140.1 (27.37)	134.3 (31.78)	139.6 (19.84)	140.7 (26.12)
High-Density Lipoprotein Cholesterol (HDL-C) (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligrams per deciliter (mg/dL)]	50.2 (12.88)	52.1 (16.15)	49.2 (11.41)	50.7 (14.39)	48.9 (13.70)	51.7 (14.47)	50.5 (13.77)
Fasting Triglycerides (TG) (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligrams per deciliter (mg/dL)]	156.1 (74.31)	133.1 (64.75)	145.4 (79.14)	138.9 (64.56)	143.1 (60.02)	144.3 (75.32)	143.4 (69.27)
Systolic Blood Pressure (millimeters of mercury (mm Hg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters of mercury (mm Hg)]	118.8 (11.75)	117.7 (12.41)	118.4 (12.61)	119.5 (11.67)	119.6 (9.82)	116.9 (13.31)	118.5 (11.84)
Diastolic Blood Pressure (millimeters of mercury (mm Hg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters of mercury (mm Hg)]	73.7 (7.32)	74.0 (9.57)	74.3 (9.77)	75.1 (7.32)	75.4 (7.58)	71.8 (8.52)	74.0 (8.37)
Pulse Rate (beats per minute (bpm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute (bpm)]	68.4 (8.90)	67.7 (7.45)	68.2 (10.41)	67.3 (11.15)	68.4 (8.14)	72.4 (8.90)	68.8 (9.26)

Outcome Measures

1. Secondary Outcome

Title	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
Description	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.
Time Frame	Baseline, Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	27	27	28	27	28
HDL-C, Week 2	75.30 (6.44)	108.21 (6.45)	122.60 (6.44)	-0.73 (6.32)	8.85 (6.45)	101.45 (6.33)
HDL-C, Week 4	77.94 (7.62)	122.68 (7.63)	147.22 (7.72)	2.09 (7.53)	10.87 (7.62)	117.04 (7.49)
HDL-C, Week 8	78.65 (7.95)	130.69 (7.91)	169.05 (8.08)	5.19 (7.82)	12.98 (7.91)	116.64 (7.90)
LDL-C, Week 2	-17.46 (3.13)	-27.50 (3.14)	-33.19 (3.13)	-2.14 (3.07)	-38.29 (3.14)	-55.74 (3.04)
LDL-C, Week 4	-13.32 (3.14)	-24.43 (3.14)	-29.25 (3.18)	2.84 (3.10)	-42.23 (3.15)	-52.62 (3.08)
LDL-C, Week 8	-12.50 (3.39)	-23.56 (3.37)	-25.48 (3.45)	0.24 (3.33)	-38.97 (3.38)	-51.23 (3.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 2.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	92.61
	Confidence Interval	(2-Sided) 90%; 77.65 to 107.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.04
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	106.17
	Confidence Interval	(2-Sided) 90%; 88.47 to 123.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.69
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	103.66
	Confidence Interval	(2-Sided) 90%; 85.14 to 122.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 11.18
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in LDL-C at Week 2.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-17.46
	Confidence Interval	(2-Sided) 90%; -24.73 to -10.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.39
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	The P-value is for percent change from baseline in LDL-C at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.39
	Confidence Interval	(2-Sided) 90%; -17.67 to -3.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.40
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments	The P-value is for percent change from baseline in LDL-C at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.26
	Confidence Interval	(2-Sided) 90%; -20.17 to -4.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.77
	Estimation Comments

2. Secondary Outcome

Title	Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin
Time Frame	Weeks 2, 4, 8, 12 (predose and postdose), and Week 16

Outcome Measure Data

Analysis Population Description

Participants who were administered LY2484595 or LY2484595 + Atorvastatin and had evaluable pharmacokinetic (PK) samples.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	The following were administered orally once daily for 12 weeks: Placebo: 4 tablets and 1 capsule LY2484595: A single 30-milligram (mg) tablet	The following were administered orally once daily for 12 weeks: Placebo: 4 tablets and 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo: 4 tablets LY2484595: A single 100-mg tablet
Measure Participants	27	27	26	27
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter (ng*h/mL)]	3110 (32)	8690 (44)	29400 (42)	8080 (47)

3. Secondary Outcome

Title	The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12
Description	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.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who took at least 1 dose of double-blind study medication intent-to-treat (ITT) population.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	28	27	28	27	28
Low risk	0	0	1	0	0	1
High risk	0	0	1	0	0	0
Not a relevant dermatosis	0	0	0	1	0	1
Insufficient documentation for determination	0	0	0	0	0	0

4. Secondary Outcome

Title	Change From Baseline to 12 Weeks in Blood Pressure
Description	Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP). LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	26	27	24	27	27	25
SBP	2.35 (1.78)	1.44 (1.76)	4.51 (1.84)	-1.39 (1.75)	2.59 (1.76)	2.04 (1.80)
DBP	1.46 (1.07)	0.02 (1.05)	2.51 (1.10)	0.68 (1.05)	1.49 (1.05)	0.51 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.136
	Comments	The P-value is for change from baseline in SBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.74
	Confidence Interval	(2-Sided) 90%; -0.39 to 7.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.50
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.257
	Comments	The P-value is for change from baseline in SBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.83
	Confidence Interval	(2-Sided) 90%; -1.28 to 6.94
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.48
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments	The P-value is for change from baseline in SBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	5.90
	Confidence Interval	(2-Sided) 90%; 1.70 to 10.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.54
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.829
	Comments	The P-value is for change from baseline in SBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 90%; -4.71 to 3.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.52
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.603
	Comments	The P-value is for change from baseline in DBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 90%; -1.69 to 3.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.50
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.656
	Comments	The P-value is for change from baseline in DBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 90%; -3.11 to 1.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.48
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.228
	Comments	The P-value is for change from baseline in DBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.83
	Confidence Interval	(2-Sided) 90%; -0.67 to 4.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.52
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.516
	Comments	The P-value is for change from baseline in DBP at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 90%; -3.47 to 1.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.51
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline to 12 Weeks in Aldosterone
Description	LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	25	25	21	25	25	24
Least Squares Mean (Standard Error) [nanograms per deciliter (ng/dL)]	-0.40 (0.79)	0.37 (0.79)	0.59 (0.84)	0.33 (0.79)	0.95 (0.79)	0.62 (0.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.513
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 90%; -2.57 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.11
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.970
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90%; -1.82 to 1.90
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.12
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.824
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.26
	Confidence Interval	(2-Sided) 90%; -1.66 to 2.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.16
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.769
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 90%; -2.18 to 1.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.12
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline to 12 Weeks in Plasma Renin Activity
Description	LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	24	24	24	26	26	24
Least Squares Mean (Standard Error) [nanograms per milliliter per hour]	-0.32 (0.23)	0.01 (0.24)	-0.21 (0.23)	-0.21 (0.23)	-0.01 (0.23)	-0.43 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.735
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90%; -0.65 to 0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.503
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 90%; -0.32 to 0.76
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.988
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.53 to 0.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.207
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 90%; -0.95 to 0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline to 12 Weeks in Serum Sodium
Description	LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	26	27	24	27	27	25
Least Squares Mean (Standard Error) [milliequivalents per liter (mEq/L)]	-0.18 (0.31)	-0.32 (0.30)	-0.07 (0.32)	-0.32 (0.30)	0.35 (0.30)	0.53 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.756
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 90%; -0.57 to 0.84
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.43
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.990
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 90%; -0.71 to 0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.43
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.565
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 90%; -0.47 to 0.97
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.44
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.678
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 90%; -0.53 to 0.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.43
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline to 12 Weeks in Serum Bicarbonate
Description	LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	26	27	24	27	27	25
Least Squares Mean (Standard Error) [milliequivalents per liter (mEq/L)]	0.63 (0.43)	0.62 (0.43)	0.62 (0.45)	0.52 (0.43)	0.62 (0.43)	1.23 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.856
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.90 to 1.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.869
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90%; -0.90 to 1.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.869
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90%; -0.92 to 1.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.62
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.317
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.61
	Confidence Interval	(2-Sided) 90%; -0.40 to 1.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

9. Secondary Outcome

Title	Number of Myopathy and Liver Injury Events
Description	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.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who took at least 1 dose of double-blind study medication (ITT population).

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	28	27	28	27	28
Blood creatine phosphokinase increased	0	1	0	0	1	0
Myalgia	0	1	0	0	1	0
Hepatic function abnormal	1	0	1	0	1	2
Gamma-glutamyltransferase increased	0	1	0	0	0	0
Alanine aminotransferase increased	0	0	0	1	0	0

10. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP)
Description	LS mean was adjusted for baseline value of the variable analyzed.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	27	27	28	27	28
Least Squares Mean (Standard Error) [milligrams per deciliter (mg/dL)]	-0.03 (0.10)	0.00 (0.10)	0.13 (0.09)	-0.01 (0.09)	-0.03 (0.10)	0.15 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.888
	Comments
	Method	ANCOVA
	Comments	Treatment was included in the model as fixed effects, baseline hsCRP as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90%; -0.24 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments
	Method	ANCOVA
	Comments	Treatment was included in the model as fixed effects, baseline hsCRP as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.21 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.296
	Comments
	Method	ANCOVA
	Comments	Treatment was included in the model as fixed effects, baseline hsCRP as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90%; -0.08 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.181
	Comments
	Method	ANCOVA
	Comments	Treatment was included in the model as fixed effects, baseline hsCRP as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

11. Secondary Outcome

Title	Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
Description	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.
Time Frame	Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	26	25	27	27	27
4 Weeks	-41.62 (4.23)	-75.26 (4.30)	-89.14 (4.38)	1.67 (4.22)	-1.33 (4.22)	-68.58 (4.21)
8 Weeks	-39.91 (4.47)	-76.23 (4.40)	-90.97 (4.57)	2.70 (4.32)	-4.89 (4.32)	-79.90 (4.60)
12 Weeks	-41.07 (3.57)	-73.86 (3.55)	-85.30 (3.69)	9.22 (3.49)	-5.69 (3.54)	-73.38 (3.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-43.29
	Confidence Interval	(2-Sided) 90%; -53.16 to -33.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.97
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-76.93
	Confidence Interval	(2-Sided) 90%; -86.89 to -66.97
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.02
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-90.81
	Confidence Interval	(2-Sided) 90%; -100.87 to -80.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.08
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-67.25
	Confidence Interval	(2-Sided) 90%; -77.12 to -57.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.96
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-42.60
	Confidence Interval	(2-Sided) 90%; -52.88 to -32.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.21
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-78.93
	Confidence Interval	(2-Sided) 90%; -89.15 to -68.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.17
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-93.67
	Confidence Interval	(2-Sided) 90%; -104.08 to -83.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.29
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-75.01
	Confidence Interval	(2-Sided) 90%; -85.46 to -64.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.31
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-50.28
	Confidence Interval	(2-Sided) 90%; -58.53 to -42.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.98
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-83.07
	Confidence Interval	(2-Sided) 90%; -91.32 to -74.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.98
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-94.51
	Confidence Interval	(2-Sided) 90%; -102.92 to -86.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.08
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in plasma CETP activity at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-67.68
	Confidence Interval	(2-Sided) 90%; -76.20 to -59.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.15
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Plasma CETP Mass
Description	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.
Time Frame	Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	27	27	25	27	27	28
4 weeks	1.88 (0.18)	3.14 (0.18)	3.54 (0.18)	0.08 (0.18)	-0.28 (0.18)	1.94 (0.17)
8 weeks	1.98 (0.21)	3.09 (0.21)	4.02 (0.22)	0.10 (0.21)	-0.21 (0.21)	1.83 (0.21)
12 weeks	1.95 (0.21)	2.96 (0.21)	3.36 (0.22)	0.13 (0.21)	-0.19 (0.21)	1.95 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.80
	Confidence Interval	(2-Sided) 90%; 1.38 to 2.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.06
	Confidence Interval	(2-Sided) 90%; 2.65 to 3.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.46
	Confidence Interval	(2-Sided) 90%; 3.04 to 3.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 4.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.22
	Confidence Interval	(2-Sided) 90%; 1.81 to 2.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 90%; 1.40 to 2.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.99
	Confidence Interval	(2-Sided) 90%; 2.51 to 3.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.92
	Confidence Interval	(2-Sided) 90%; 3.42 to 4.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 8.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.04
	Confidence Interval	(2-Sided) 90%; 1.56 to 2.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.82
	Confidence Interval	(2-Sided) 90%; 1.34 to 2.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.83
	Confidence Interval	(2-Sided) 90%; 2.34 to 3.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.24
	Confidence Interval	(2-Sided) 90%; 2.74 to 3.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for change from baseline in plasma CETP mass at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.14
	Confidence Interval	(2-Sided) 90%; 1.65 to 2.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

13. Primary Outcome

Title	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
Description	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.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	30 mg LY2484595	100 mg LY2484595	500 mg LY2484595	Placebo	10 mg Atorvastatin	100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	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	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet	The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule	The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets	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
Measure Participants	26	27	24	27	27	25
HDL-C	82.22 (8.97)	123.35 (8.92)	143.56 (9.16)	8.00 (8.83)	17.35 (8.91)	120.60 (8.95)
LDL-C	-14.23 (3.46)	-22.13 (3.43)	-20.95 (3.55)	1.24 (3.40)	-37.66 (3.44)	-52.29 (3.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	74.23
	Confidence Interval	(2-Sided) 90%; 53.38 to 95.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 12.59
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	115.36
	Confidence Interval	(2-Sided) 90%; 94.58 to 136.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 12.55
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	135.57
	Confidence Interval	(2-Sided) 90%; 114.50 to 156.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 12.72
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	30 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	The P-value is for percent change from baseline in LDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-15.47
	Confidence Interval	(2-Sided) 90%; -23.50 to -7.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.85
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	100 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in LDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-23.37
	Confidence Interval	(2-Sided) 90%; -31.37 to -15.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.83
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	500 mg LY2484595, Placebo
	Comments	Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in LDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-22.19
	Confidence Interval	(2-Sided) 90%; -30.32 to -14.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.91
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The P-value is for percent change from baseline in HDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	103.25
	Confidence Interval	(2-Sided) 90%; 82.32 to 124.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 12.64
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	10 mg Atorvastatin, 100 mg LY2484595 + 10 mg Atorvastatin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	The P-value is for percent change from baseline in LDL-C at Week 12.
	Method	Mixed Models Analysis
	Comments	Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-14.63
	Confidence Interval	(2-Sided) 90%; -22.72 to -6.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.88
	Estimation Comments

Adverse Events

Arm/Group Title	30 mg LY2484595		100 mg LY2484595		500 mg LY2484595		Placebo		10 mg Atorvastatin		100 mg LY2484595 + 10 mg Atorvastatin
Arm/Group Description	The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet		The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet		The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets		The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule		The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets		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
All Cause Mortality
	30 mg LY2484595		100 mg LY2484595		500 mg LY2484595		Placebo		10 mg Atorvastatin		100 mg LY2484595 + 10 mg Atorvastatin
	Affected / at Risk (%)	# Events	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)		/ (NaN)
Serious Adverse Events
	30 mg LY2484595		100 mg LY2484595		500 mg LY2484595		Placebo		10 mg Atorvastatin		100 mg LY2484595 + 10 mg Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/28 (0%)		1/27 (3.7%)		1/28 (3.6%)		0/27 (0%)		0/28 (0%)
General disorders
Pyrexia	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Injury, poisoning and procedural complications
Lumbar vertebral fracture	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Sternal fracture	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Traumatic lung injury	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Skin and subcutaneous tissue disorders
Toxic skin eruption	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Other (Not Including Serious) Adverse Events
	30 mg LY2484595		100 mg LY2484595		500 mg LY2484595		Placebo		10 mg Atorvastatin		100 mg LY2484595 + 10 mg Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/27 (44.4%)		12/28 (42.9%)		10/27 (37%)		8/28 (28.6%)		10/27 (37%)		10/28 (35.7%)
Blood and lymphatic system disorders
Leukopenia	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Eye disorders
Asthenopia	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Abdominal distension	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Abdominal pain lower	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Cheilitis	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Constipation	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	1/28 (3.6%)	1
Dental caries	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Diarrhoea	1/27 (3.7%)	1	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Dyspepsia	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0
Gastrooesophageal reflux disease	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Gingivitis	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Haemorrhoids	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Mouth ulceration	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Periodontitis	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Periproctitis	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
General disorders
Feeling hot	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Malaise	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Hepatic function abnormal	1/27 (3.7%)	1	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	1/27 (3.7%)	1	2/28 (7.1%)	2
Infections and infestations
Bronchitis	1/27 (3.7%)	1	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Cellulitis	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Gastroenteritis	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	2/27 (7.4%)	2	1/28 (3.6%)	1
Impetigo	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Influenza	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Nasopharyngitis	3/27 (11.1%)	4	6/28 (21.4%)	6	3/27 (11.1%)	3	2/28 (7.1%)	2	3/27 (11.1%)	3	3/28 (10.7%)	3
Pertussis	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Pharyngitis	1/27 (3.7%)	1	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Respiratory tract infection	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Tinea pedis	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Upper respiratory tract infection	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Injury, poisoning and procedural complications
Laceration	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Ligament sprain	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Investigations
Alanine aminotransferase increased	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0
Blood creatine phosphokinase increased	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0
Eosinophil count increased	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Gamma-glutamyltransferase increased	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Metabolism and nutrition disorders
Gout	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Back pain	0/27 (0%)	0	1/28 (3.6%)	1	1/27 (3.7%)	1	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0
Intervertebral disc protrusion	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Myalgia	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0
Spinal osteoarthritis	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Nervous system disorders
Headache	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	1/28 (3.6%)	1
Tension headache	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Reproductive system and breast disorders
Vulvovaginal pruritus	0/27 (0%)	0	1/28 (3.6%)	1	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Oropharyngeal pain	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0
Rhinitis allergic	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	2	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1
Upper respiratory tract inflammation	0/27 (0%)	0	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1	1/27 (3.7%)	1	0/28 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Dry skin	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	0/28 (0%)	0
Rash	0/27 (0%)	0	0/28 (0%)	0	1/27 (3.7%)	1	0/28 (0%)	0	0/27 (0%)	0	1/28 (3.6%)	1

Limitations/Caveats

[Not Specified]

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.