A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

Eli Lilly and Company398 enrolled

Overview

The primary purpose of your participation in this study is to help answer the following research question(s) * Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone. * Whether LY2484595 alone improves blood fats profile compared to sugar pills. * Whether LY2484595 interferes with break down or functioning of statins. * Whether LY2484595 has any side effects that would not support testing it in future studies.

Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

398

Conditions

Dyslipidemia

Interventions

LY2484595DRUG

Administered daily by mouth for 12 weeks

AtorvastatinDRUG

Administered daily by mouth for 12 weeks

SimvastatinDRUG

Administered daily by mouth for 12 weeks

Rosuvastatin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies Exclusion Criteria: * History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well * Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram \[ECG\]) to be compatible with participation in the study * History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema) * Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors) * Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs * Not willing to follow the diet (low-fat) that the study physician will recommend * Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study * Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies

Locations (59)

Outcomes

Primary Outcomes

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Secondary Outcomes

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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Administered daily by mouth for 12 weeks

Placebo for LY2484595DRUG

Administered daily by mouth for 12 weeks

Placebo for StatinsDRUG

Administered daily by mouth for 12 weeks

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.

Fayetteville, Arkansas, United States

San Diego, California, United States

Spring Valley, California, United States

Vista, California, United States

Golden, Colorado, United States

Brandon, Florida, United States

Jacksonville, Florida, United States

Longwood, Florida, United States

Ponte Vedra, Florida, United States

Indianapolis, Indiana, United States

...and 49 more locations

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State

Time frame: Baseline up to 12 weeks

Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

The Number 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 (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.

Time frame: Baseline through Week 12

Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 12 Weeks Endpoint in Serum Potassium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 12 Weeks Endpoint in Serum Sodium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline, Week 12

Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score

EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame: Baseline up to Week 18