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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atorvastatin; Atorvastatin Calcium; Evacetrapib; Rosuvastatin Calcium; Simvastatin

Criteria

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