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

Lilly

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Simvastatin; Drug: Rosuvastatin; Drug: Placebo for LY2484595; Drug: LY2484595; Drug: Atorvastatin; Drug: Placebo for Statins

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105975

12468

I1V-MC-EIAF (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

398 participants in 10 patient groups, including a placebo group

30 milligram (mg) LY2484595 monotherapy

Experimental group

Treatment:

Drug: Placebo for Statins

Drug: LY2484595

100 mg LY2484595 monotherapy

Experimental group

Treatment:

Drug: Placebo for Statins

Drug: LY2484595

500 mg LY2484595 monotherapy

Experimental group

Treatment:

Drug: Placebo for Statins

Drug: LY2484595

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo for Statins

Drug: Placebo for LY2484595

20 mg Atorvastatin monotherapy

Active Comparator group

Treatment:

Drug: Atorvastatin

Drug: Placebo for LY2484595

100 mg LY2484595 + 20 mg Atorvastatin

Experimental group

Treatment:

Drug: Atorvastatin

Drug: LY2484595

40 mg Simvastatin monotherapy

Active Comparator group

Treatment:

Drug: Placebo for LY2484595

Drug: Simvastatin

100 mg LY2484595 + 40 mg Simvastatin

Experimental group

Treatment:

Drug: LY2484595

Drug: Simvastatin

10 mg Rosuvastatin monotherapy

Active Comparator group

Treatment:

Drug: Rosuvastatin

Drug: Placebo for LY2484595

100 mg LY2484595 + 10 mg Rosuvastatin

Experimental group

Treatment:

Drug: Rosuvastatin

Drug: LY2484595