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



Status:Completed
Conditions:High Cholesterol, High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2010
End Date:June 2011

Use our guide to learn which trials are right for you!

A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C

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.

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
We found this trial at
39
sites
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
714
mi
from 43215
Auburn, ME
Click here to add this to my saved trials
4189
mi
from 43215
Ballerup,
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
831
mi
from 43215
Brandon, FL
Click here to add this to my saved trials
239
mi
from 43215
Bristol, TN
Click here to add this to my saved trials
369
mi
from 43215
Cary, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
457
mi
from 43215
Edison, NJ
Click here to add this to my saved trials
393
mi
from 43215
Endwell, NY
Click here to add this to my saved trials
659
mi
from 43215
Fayetteville, AR
Click here to add this to my saved trials
1174
mi
from 43215
Golden, CO
Click here to add this to my saved trials
Greensboro, North Carolina 27401
321
mi
from 43215
Greensboro, NC
Click here to add this to my saved trials
351
mi
from 43215
Greer, SC
Click here to add this to my saved trials
304
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
237
mi
from 43215
Kingsport, TN
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
783
mi
from 43215
Longwood, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
524
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
387
mi
from 43215
Oregon, WI
Click here to add this to my saved trials
751
mi
from 43215
Picayune, MS
Click here to add this to my saved trials
727
mi
from 43215
Ponte Vedra, FL
Click here to add this to my saved trials
371
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
388
mi
from 43215
Red Lion, PA
Click here to add this to my saved trials
Salisbury, North Carolina 28144
327
mi
from 43215
Salisbury, NC
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
363
mi
from 43215
Simpsonville, SC
Click here to add this to my saved trials
Spring Valley, California 91978
1942
mi
from 43215
Spring Valley, CA
Click here to add this to my saved trials
2012
mi
from 43215
Tacoma, WA
Click here to add this to my saved trials
1943
mi
from 43215
Vista, CA
Click here to add this to my saved trials
514
mi
from 43215
Waterloo, IA
Click here to add this to my saved trials
784
mi
from 43215
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
484
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials
433
mi
from 43215
Yardley, PA
Click here to add this to my saved trials