Dyslipidemias
Conditions
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | Weeks 2, 4, 8, 12 (predose and postdose), and Week 16 | — |
| 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. |
| 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. |
| Change From Baseline to 12 Weeks in Aldosterone | Baseline and Week 12 | LS mean was adjusted for baseline value of the variable analyzed. |
| 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. |
| 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. |
| Change From Baseline to 12 Weeks in Serum Bicarbonate | Baseline and Week 12 | LS mean was adjusted for baseline value of the variable analyzed. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change From Baseline to 12 Weeks in Serum Sodium | Baseline and Week 12 | LS mean was adjusted for baseline value of the variable analyzed. |
Countries
Japan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 30 mg LY2484595 The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet | 27 |
| 100 mg LY2484595 The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet | 28 |
| 500 mg LY2484595 The following were administered orally once daily for 12 weeks:
Placebo (Atorvastatin): 1 capsule
LY2484595: five 100-mg tablets | 27 |
| Placebo The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 5 tablets
Placebo (Atorvastatin): 1 capsule | 28 |
| 10 mg Atorvastatin The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
Placebo (LY2484595): 5 tablets | 27 |
| 100 mg LY2484595 + 10 mg Atorvastatin The following were administered orally once daily for 12 weeks:
Atorvastatin: A single 10-mg capsule
LY2484595: A single 100-mg tablet
Placebo (LY2484595): 4 tablets | 28 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 3 | 1 | 0 | 1 |
| Overall Study | Entry Criterion Not Met | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 30 mg LY2484595 | 100 mg LY2484595 | 500 mg LY2484595 | Placebo | 10 mg Atorvastatin | 100 mg LY2484595 + 10 mg Atorvastatin | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 10.95 | 47.6 years STANDARD_DEVIATION 11.94 | 49.4 years STANDARD_DEVIATION 8.1 | 50.3 years STANDARD_DEVIATION 9.63 | 49.4 years STANDARD_DEVIATION 8.76 | 50.0 years STANDARD_DEVIATION 10.01 | 49.2 years STANDARD_DEVIATION 9.88 |
| Body Mass Index (BMI) | 24.9 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.38 | 24.0 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.15 | 24.5 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.1 | 25.1 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.7 | 24.1 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.35 | 25.5 kilograms per square meter (kg/m²) STANDARD_DEVIATION 5.49 | 24.7 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.93 |
| Diastolic Blood Pressure | 73.7 millimeters of mercury (mm Hg) STANDARD_DEVIATION 7.32 | 74.0 millimeters of mercury (mm Hg) STANDARD_DEVIATION 9.57 | 74.3 millimeters of mercury (mm Hg) STANDARD_DEVIATION 9.77 | 75.1 millimeters of mercury (mm Hg) STANDARD_DEVIATION 7.32 | 75.4 millimeters of mercury (mm Hg) STANDARD_DEVIATION 7.58 | 71.8 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.52 | 74.0 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.37 |
| Fasting Triglycerides (TG) | 156.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 74.31 | 133.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 64.75 | 145.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 79.14 | 138.9 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 64.56 | 143.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 60.02 | 144.3 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 75.32 | 143.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 69.27 |
| Height | 165.1 centimeters (cm) STANDARD_DEVIATION 9.48 | 165.4 centimeters (cm) STANDARD_DEVIATION 9.95 | 166.5 centimeters (cm) STANDARD_DEVIATION 9.27 | 165.6 centimeters (cm) STANDARD_DEVIATION 8.56 | 166.7 centimeters (cm) STANDARD_DEVIATION 6.76 | 165.2 centimeters (cm) STANDARD_DEVIATION 8.34 | 165.7 centimeters (cm) STANDARD_DEVIATION 8.68 |
| High-Density Lipoprotein Cholesterol (HDL-C) | 50.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 12.88 | 52.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 16.15 | 49.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 11.41 | 50.7 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 14.39 | 48.9 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 13.7 | 51.7 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 14.47 | 50.5 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 13.77 |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 143.9 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 24.02 | 143.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 23.05 | 142.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.16 | 140.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.37 | 134.3 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 31.78 | 139.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 19.84 | 140.7 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 26.12 |
| Pulse Rate | 68.4 beats per minute (bpm) STANDARD_DEVIATION 8.9 | 67.7 beats per minute (bpm) STANDARD_DEVIATION 7.45 | 68.2 beats per minute (bpm) STANDARD_DEVIATION 10.41 | 67.3 beats per minute (bpm) STANDARD_DEVIATION 11.15 | 68.4 beats per minute (bpm) STANDARD_DEVIATION 8.14 | 72.4 beats per minute (bpm) STANDARD_DEVIATION 8.9 | 68.8 beats per minute (bpm) STANDARD_DEVIATION 9.26 |
| Race/Ethnicity, Customized Japanese | 27 Participants | 28 Participants | 27 Participants | 28 Participants | 27 Participants | 28 Participants | 165 Participants |
| Region of Enrollment Japan | 27 Participants | 28 Participants | 27 Participants | 28 Participants | 27 Participants | 28 Participants | 165 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 9 Participants | 10 Participants | 8 Participants | 10 Participants | 55 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 18 Participants | 18 Participants | 19 Participants | 18 Participants | 110 Participants |
| Systolic Blood Pressure | 118.8 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.75 | 117.7 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.41 | 118.4 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.61 | 119.5 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.67 | 119.6 millimeters of mercury (mm Hg) STANDARD_DEVIATION 9.82 | 116.9 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.31 | 118.5 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.84 |
| Weight | 68.5 kilograms (kg) STANDARD_DEVIATION 14.04 | 65.9 kilograms (kg) STANDARD_DEVIATION 11.58 | 68.5 kilograms (kg) STANDARD_DEVIATION 15.71 | 69.3 kilograms (kg) STANDARD_DEVIATION 13.51 | 67.4 kilograms (kg) STANDARD_DEVIATION 12.77 | 70.3 kilograms (kg) STANDARD_DEVIATION 18.33 | 68.3 kilograms (kg) STANDARD_DEVIATION 14.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 27 | 12 / 28 | 10 / 27 | 8 / 28 | 10 / 27 | 10 / 28 |
| serious Total, serious adverse events | 0 / 27 | 0 / 28 | 1 / 27 | 1 / 28 | 0 / 27 | 0 / 28 |
Outcome results
Primary
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
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 82.22 percent change | Standard Error 8.97 |
| 30 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | -14.23 percent change | Standard Error 3.46 |
| 100 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 123.35 percent change | Standard Error 8.92 |
| 100 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | -22.13 percent change | Standard Error 3.43 |
| 500 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 143.56 percent change | Standard Error 9.16 |
| 500 mg LY2484595 | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | -20.95 percent change | Standard Error 3.55 |
| Placebo | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 8.00 percent change | Standard Error 8.83 |
| Placebo | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | 1.24 percent change | Standard Error 3.4 |
| 10 mg Atorvastatin | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 17.35 percent change | Standard Error 8.91 |
| 10 mg Atorvastatin | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | -37.66 percent change | Standard Error 3.44 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | HDL-C | 120.60 percent change | Standard Error 8.95 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | LDL-C | -52.29 percent change | Standard Error 3.47 |
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: <0.00190% CI: [53.38, 95.07]Mixed Models Analysis
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: <0.00190% CI: [94.58, 136.14]Mixed Models Analysis
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: <0.00190% CI: [114.5, 156.63]Mixed Models Analysis
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: 0.00290% CI: [-23.5, -7.43]Mixed Models Analysis
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: <0.00190% CI: [-31.37, -15.38]Mixed Models Analysis
Comparison: Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.p-value: <0.00190% CI: [-30.32, -14.06]Mixed Models Analysis
p-value: <0.00190% CI: [82.32, 124.18]Mixed Models Analysis
p-value: 0.00390% CI: [-22.72, -6.55]Mixed Models Analysis
Secondary
Change From Baseline in Plasma CETP Mass
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 8 weeks | 1.98 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 30 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 4 weeks | 1.88 micrograms per milliliter (µg/mL) | Standard Error 0.18 |
| 30 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 12 weeks | 1.95 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 100 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 8 weeks | 3.09 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 100 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 4 weeks | 3.14 micrograms per milliliter (µg/mL) | Standard Error 0.18 |
| 100 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 12 weeks | 2.96 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 500 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 8 weeks | 4.02 micrograms per milliliter (µg/mL) | Standard Error 0.22 |
| 500 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 4 weeks | 3.54 micrograms per milliliter (µg/mL) | Standard Error 0.18 |
| 500 mg LY2484595 | Change From Baseline in Plasma CETP Mass | 12 weeks | 3.36 micrograms per milliliter (µg/mL) | Standard Error 0.22 |
| Placebo | Change From Baseline in Plasma CETP Mass | 8 weeks | 0.10 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| Placebo | Change From Baseline in Plasma CETP Mass | 4 weeks | 0.08 micrograms per milliliter (µg/mL) | Standard Error 0.18 |
| Placebo | Change From Baseline in Plasma CETP Mass | 12 weeks | 0.13 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 8 weeks | -0.21 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 4 weeks | -0.28 micrograms per milliliter (µg/mL) | Standard Error 0.18 |
| 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 12 weeks | -0.19 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 4 weeks | 1.94 micrograms per milliliter (µg/mL) | Standard Error 0.17 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 12 weeks | 1.95 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline in Plasma CETP Mass | 8 weeks | 1.83 micrograms per milliliter (µg/mL) | Standard Error 0.21 |
p-value: <0.00190% CI: [1.38, 2.21]Mixed Models Analysis
p-value: <0.00190% CI: [2.65, 3.48]Mixed Models Analysis
p-value: <0.00190% CI: [3.04, 3.88]Mixed Models Analysis
p-value: <0.00190% CI: [1.81, 2.63]Mixed Models Analysis
p-value: <0.00190% CI: [1.4, 2.36]Mixed Models Analysis
p-value: <0.00190% CI: [2.51, 3.47]Mixed Models Analysis
p-value: <0.00190% CI: [3.42, 4.41]Mixed Models Analysis
p-value: <0.00190% CI: [1.56, 2.52]Mixed Models Analysis
p-value: <0.00190% CI: [1.34, 2.31]Mixed Models Analysis
p-value: <0.00190% CI: [2.34, 3.31]Mixed Models Analysis
p-value: <0.00190% CI: [2.74, 3.73]Mixed Models Analysis
p-value: <0.00190% CI: [1.65, 2.63]Mixed Models Analysis
Secondary
Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP)
LS mean was adjusted for baseline value of the variable analyzed.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | -0.03 milligrams per deciliter (mg/dL) | Standard Error 0.1 |
| 100 mg LY2484595 | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | 0.00 milligrams per deciliter (mg/dL) | Standard Error 0.1 |
| 500 mg LY2484595 | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | 0.13 milligrams per deciliter (mg/dL) | Standard Error 0.09 |
| Placebo | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | -0.01 milligrams per deciliter (mg/dL) | Standard Error 0.09 |
| 10 mg Atorvastatin | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | -0.03 milligrams per deciliter (mg/dL) | Standard Error 0.1 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | 0.15 milligrams per deciliter (mg/dL) | Standard Error 0.09 |
p-value: 0.18190% CI: [-0.04, 0.4]ANCOVA
p-value: 0.88890% CI: [-0.24, 0.2]ANCOVA
p-value: 0.93990% CI: [-0.21, 0.23]ANCOVA
p-value: 0.29690% CI: [-0.08, 0.36]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Aldosterone
LS mean was adjusted for baseline value of the variable analyzed.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Aldosterone | -0.40 nanograms per deciliter (ng/dL) | Standard Error 0.79 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Aldosterone | 0.37 nanograms per deciliter (ng/dL) | Standard Error 0.79 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Aldosterone | 0.59 nanograms per deciliter (ng/dL) | Standard Error 0.84 |
| Placebo | Change From Baseline to 12 Weeks in Aldosterone | 0.33 nanograms per deciliter (ng/dL) | Standard Error 0.79 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Aldosterone | 0.95 nanograms per deciliter (ng/dL) | Standard Error 0.79 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Aldosterone | 0.62 nanograms per deciliter (ng/dL) | Standard Error 0.79 |
p-value: 0.51390% CI: [-2.57, 1.11]Mixed Models Analysis
p-value: 0.9790% CI: [-1.82, 1.9]Mixed Models Analysis
p-value: 0.82490% CI: [-1.66, 2.17]Mixed Models Analysis
p-value: 0.76990% CI: [-2.18, 1.52]Mixed Models Analysis
Secondary
Change From Baseline to 12 Weeks in Blood Pressure
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | SBP | 2.35 millimeters of mercury (mm Hg) | Standard Error 1.78 |
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 1.46 millimeters of mercury (mm Hg) | Standard Error 1.07 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | SBP | 1.44 millimeters of mercury (mm Hg) | Standard Error 1.76 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 0.02 millimeters of mercury (mm Hg) | Standard Error 1.05 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | SBP | 4.51 millimeters of mercury (mm Hg) | Standard Error 1.84 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 2.51 millimeters of mercury (mm Hg) | Standard Error 1.1 |
| Placebo | Change From Baseline to 12 Weeks in Blood Pressure | SBP | -1.39 millimeters of mercury (mm Hg) | Standard Error 1.75 |
| Placebo | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 0.68 millimeters of mercury (mm Hg) | Standard Error 1.05 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Blood Pressure | SBP | 2.59 millimeters of mercury (mm Hg) | Standard Error 1.76 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 1.49 millimeters of mercury (mm Hg) | Standard Error 1.05 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Blood Pressure | SBP | 2.04 millimeters of mercury (mm Hg) | Standard Error 1.8 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Blood Pressure | DBP | 0.51 millimeters of mercury (mm Hg) | Standard Error 1.08 |
p-value: 0.13690% CI: [-0.39, 7.88]Mixed Models Analysis
p-value: 0.25790% CI: [-1.28, 6.94]Mixed Models Analysis
p-value: 0.02190% CI: [1.7, 10.1]Mixed Models Analysis
p-value: 0.82990% CI: [-4.71, 3.62]Mixed Models Analysis
p-value: 0.60390% CI: [-1.69, 3.24]Mixed Models Analysis
p-value: 0.65690% CI: [-3.11, 1.78]Mixed Models Analysis
p-value: 0.22890% CI: [-0.67, 4.34]Mixed Models Analysis
p-value: 0.51690% CI: [-3.47, 1.51]Mixed Models Analysis
Secondary
Change From Baseline to 12 Weeks in Plasma Renin Activity
LS mean was adjusted for baseline value of the variable analyzed.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Plasma Renin Activity | -0.32 nanograms per milliliter per hour | Standard Error 0.23 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Plasma Renin Activity | 0.01 nanograms per milliliter per hour | Standard Error 0.24 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Plasma Renin Activity | -0.21 nanograms per milliliter per hour | Standard Error 0.23 |
| Placebo | Change From Baseline to 12 Weeks in Plasma Renin Activity | -0.21 nanograms per milliliter per hour | Standard Error 0.23 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Plasma Renin Activity | -0.01 nanograms per milliliter per hour | Standard Error 0.23 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Plasma Renin Activity | -0.43 nanograms per milliliter per hour | Standard Error 0.23 |
p-value: 0.73590% CI: [-0.65, 0.43]Mixed Models Analysis
p-value: 0.50390% CI: [-0.32, 0.76]Mixed Models Analysis
p-value: 0.98890% CI: [-0.53, 0.54]Mixed Models Analysis
p-value: 0.20790% CI: [-0.95, 0.13]Mixed Models Analysis
Secondary
Change From Baseline to 12 Weeks in Serum Bicarbonate
LS mean was adjusted for baseline value of the variable analyzed.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Bicarbonate | 0.63 milliequivalents per liter (mEq/L) | Standard Error 0.43 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Bicarbonate | 0.62 milliequivalents per liter (mEq/L) | Standard Error 0.43 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Bicarbonate | 0.62 milliequivalents per liter (mEq/L) | Standard Error 0.45 |
| Placebo | Change From Baseline to 12 Weeks in Serum Bicarbonate | 0.52 milliequivalents per liter (mEq/L) | Standard Error 0.43 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Serum Bicarbonate | 0.62 milliequivalents per liter (mEq/L) | Standard Error 0.43 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Serum Bicarbonate | 1.23 milliequivalents per liter (mEq/L) | Standard Error 0.44 |
p-value: 0.85690% CI: [-0.9, 1.12]Mixed Models Analysis
p-value: 0.86990% CI: [-0.9, 1.1]Mixed Models Analysis
p-value: 0.86990% CI: [-0.92, 1.13]Mixed Models Analysis
p-value: 0.31790% CI: [-0.4, 1.63]Mixed Models Analysis
Secondary
Change From Baseline to 12 Weeks in Serum Sodium
LS mean was adjusted for baseline value of the variable analyzed.
Time frame: Baseline and Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Sodium | -0.18 milliequivalents per liter (mEq/L) | Standard Error 0.31 |
| 100 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Sodium | -0.32 milliequivalents per liter (mEq/L) | Standard Error 0.3 |
| 500 mg LY2484595 | Change From Baseline to 12 Weeks in Serum Sodium | -0.07 milliequivalents per liter (mEq/L) | Standard Error 0.32 |
| Placebo | Change From Baseline to 12 Weeks in Serum Sodium | -0.32 milliequivalents per liter (mEq/L) | Standard Error 0.3 |
| 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Serum Sodium | 0.35 milliequivalents per liter (mEq/L) | Standard Error 0.3 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Change From Baseline to 12 Weeks in Serum Sodium | 0.53 milliequivalents per liter (mEq/L) | Standard Error 0.31 |
p-value: 0.75690% CI: [-0.57, 0.84]Mixed Models Analysis
p-value: 0.9990% CI: [-0.71, 0.7]Mixed Models Analysis
p-value: 0.56590% CI: [-0.47, 0.97]Mixed Models Analysis
p-value: 0.67890% CI: [-0.53, 0.89]Mixed Models Analysis
Secondary
Number of Myopathy and Liver Injury Events
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
Population: All randomized participants who took at least 1 dose of double-blind study medication (ITT population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 30 mg LY2484595 | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 1 events |
| 30 mg LY2484595 | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 0 events |
| 30 mg LY2484595 | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 0 events |
| 30 mg LY2484595 | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 0 events |
| 30 mg LY2484595 | Number of Myopathy and Liver Injury Events | Myalgia | 0 events |
| 100 mg LY2484595 | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 1 events |
| 100 mg LY2484595 | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 0 events |
| 100 mg LY2484595 | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 0 events |
| 100 mg LY2484595 | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 1 events |
| 100 mg LY2484595 | Number of Myopathy and Liver Injury Events | Myalgia | 1 events |
| 500 mg LY2484595 | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 0 events |
| 500 mg LY2484595 | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 1 events |
| 500 mg LY2484595 | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 0 events |
| 500 mg LY2484595 | Number of Myopathy and Liver Injury Events | Myalgia | 0 events |
| 500 mg LY2484595 | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 0 events |
| Placebo | Number of Myopathy and Liver Injury Events | Myalgia | 0 events |
| Placebo | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 1 events |
| Placebo | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 0 events |
| Placebo | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 0 events |
| Placebo | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 0 events |
| 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 1 events |
| 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 0 events |
| 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 0 events |
| 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 1 events |
| 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Myalgia | 1 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Alanine aminotransferase increased | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Hepatic function abnormal | 2 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Blood creatine phosphokinase increased | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Gamma-glutamyltransferase increased | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | Number of Myopathy and Liver Injury Events | Myalgia | 0 events |
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -17.46 percent change | Standard Error 3.13 |
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 77.94 percent change | Standard Error 7.62 |
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | 75.30 percent change | Standard Error 6.44 |
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 78.65 percent change | Standard Error 7.95 |
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | -12.50 percent change | Standard Error 3.39 |
| 30 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | -13.32 percent change | Standard Error 3.14 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 122.68 percent change | Standard Error 7.63 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -27.50 percent change | Standard Error 3.14 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 130.69 percent change | Standard Error 7.91 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | -24.43 percent change | Standard Error 3.14 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | 108.21 percent change | Standard Error 6.45 |
| 100 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | -23.56 percent change | Standard Error 3.37 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | 122.60 percent change | Standard Error 6.44 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | -29.25 percent change | Standard Error 3.18 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | -25.48 percent change | Standard Error 3.45 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 147.22 percent change | Standard Error 7.72 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 169.05 percent change | Standard Error 8.08 |
| 500 mg LY2484595 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -33.19 percent change | Standard Error 3.13 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | 2.84 percent change | Standard Error 3.1 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 2.09 percent change | Standard Error 7.53 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | -0.73 percent change | Standard Error 6.32 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | 0.24 percent change | Standard Error 3.33 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 5.19 percent change | Standard Error 7.82 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -2.14 percent change | Standard Error 3.07 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 10.87 percent change | Standard Error 7.62 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | -38.97 percent change | Standard Error 3.38 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -38.29 percent change | Standard Error 3.14 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | 8.85 percent change | Standard Error 6.45 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 12.98 percent change | Standard Error 7.91 |
| 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | -42.23 percent change | Standard Error 3.15 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 8 | -51.23 percent change | Standard Error 3.38 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 4 | -52.62 percent change | Standard Error 3.08 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 8 | 116.64 percent change | Standard Error 7.9 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | LDL-C, Week 2 | -55.74 percent change | Standard Error 3.04 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 2 | 101.45 percent change | Standard Error 6.33 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | HDL-C, Week 4 | 117.04 percent change | Standard Error 7.49 |
p-value: <0.00190% CI: [77.65, 107.57]Mixed Models Analysis
p-value: <0.00190% CI: [88.47, 123.87]Mixed Models Analysis
p-value: <0.00190% CI: [85.14, 122.17]Mixed Models Analysis
p-value: <0.00190% CI: [-24.73, -10.19]Mixed Models Analysis
p-value: 0.01990% CI: [-17.67, -3.11]Mixed Models Analysis
p-value: 0.01190% CI: [-20.17, -4.36]Mixed Models Analysis
Secondary
Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | -39.91 percent change in CETP activity | Standard Error 4.47 |
| 30 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | -41.62 percent change in CETP activity | Standard Error 4.23 |
| 30 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | -41.07 percent change in CETP activity | Standard Error 3.57 |
| 100 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | -76.23 percent change in CETP activity | Standard Error 4.4 |
| 100 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | -75.26 percent change in CETP activity | Standard Error 4.3 |
| 100 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | -73.86 percent change in CETP activity | Standard Error 3.55 |
| 500 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | -90.97 percent change in CETP activity | Standard Error 4.57 |
| 500 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | -89.14 percent change in CETP activity | Standard Error 4.38 |
| 500 mg LY2484595 | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | -85.30 percent change in CETP activity | Standard Error 3.69 |
| Placebo | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | 2.70 percent change in CETP activity | Standard Error 4.32 |
| Placebo | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | 1.67 percent change in CETP activity | Standard Error 4.22 |
| Placebo | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | 9.22 percent change in CETP activity | Standard Error 3.49 |
| 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | -4.89 percent change in CETP activity | Standard Error 4.32 |
| 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | -1.33 percent change in CETP activity | Standard Error 4.22 |
| 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | -5.69 percent change in CETP activity | Standard Error 3.54 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 4 Weeks | -68.58 percent change in CETP activity | Standard Error 4.21 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 12 Weeks | -73.38 percent change in CETP activity | Standard Error 3.74 |
| 100 mg LY2484595 + 10 mg Atorvastatin | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | 8 Weeks | -79.90 percent change in CETP activity | Standard Error 4.6 |
p-value: <0.00190% CI: [-53.16, -33.41]Mixed Models Analysis
p-value: <0.00190% CI: [-86.89, -66.97]Mixed Models Analysis
p-value: <0.00190% CI: [-100.87, -80.75]Mixed Models Analysis
p-value: <0.00190% CI: [-77.12, -57.39]Mixed Models Analysis
p-value: <0.00190% CI: [-52.88, -32.33]Mixed Models Analysis
p-value: <0.00190% CI: [-89.15, -68.71]Mixed Models Analysis
p-value: <0.00190% CI: [-104.08, -83.26]Mixed Models Analysis
p-value: <0.00190% CI: [-85.46, -64.57]Mixed Models Analysis
p-value: <0.00190% CI: [-58.53, -42.04]Mixed Models Analysis
p-value: <0.00190% CI: [-91.32, -74.83]Mixed Models Analysis
p-value: <0.00190% CI: [-102.92, -86.1]Mixed Models Analysis
p-value: <0.00190% CI: [-76.2, -59.16]Mixed Models Analysis
Secondary
Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin
Time frame: Weeks 2, 4, 8, 12 (predose and postdose), and Week 16
Population: Participants who were administered LY2484595 or LY2484595 + Atorvastatin and had evaluable pharmacokinetic (PK) samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 30 mg LY2484595 | Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | 3110 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 32 |
| 100 mg LY2484595 | Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | 8690 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 44 |
| 500 mg LY2484595 | Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | 29400 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 42 |
| Placebo | Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | 8080 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 47 |
Secondary
The Number and Severity of Episodes of Rashes at Any Time From 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.
Time frame: Baseline through Week 12
Population: All randomized participants who took at least 1 dose of double-blind study medication intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 30 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 0 events |
| 30 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 0 events |
| 30 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 0 events |
| 30 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| 100 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 0 events |
| 100 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 0 events |
| 100 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 0 events |
| 100 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| 500 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| 500 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 0 events |
| 500 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 1 events |
| 500 mg LY2484595 | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 1 events |
| Placebo | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 0 events |
| Placebo | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| Placebo | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 0 events |
| Placebo | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 1 events |
| 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 0 events |
| 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 0 events |
| 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | High risk | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Not a relevant dermatosis | 1 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Insufficient documentation for determination | 0 events |
| 100 mg LY2484595 + 10 mg Atorvastatin | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | Low risk | 1 events |