A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia



Status:Completed
Conditions:Metabolic
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2012
End Date:July 2013

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

A Multicenter, Randomized, Active Comparator, Placebo Controlled, Double-blind Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

This study is to determine a dose response signal for LCQ908 monotherapy and to assess the
efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.


Inclusion Criteria:

- Male and female subjects ages >18 years of age, inclusive.

- History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent
plasma in the fasting state.

- Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for
those failing to qualify initially and thought likely to qualify on repeat
examination prior to randomization.

Exclusion Criteria:

- Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.

- Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with
hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound
heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII,
CPIHBP1, or LMF1) prior to screening.

- Pancreatitis within 3 months prior to screening.

- Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at
screening)

- BMI > 40 or history of bariatric surgery.

- Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.

- Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2

Other protocol defined inclusion/exclusion criteria may apply
We found this trial at
27
sites
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Boerne, Texas 78006
?
mi
from
Boerne, TX
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
Cary, North Carolina 27511
?
mi
from
Cary, NC
Click here to add this to my saved trials
Chicoutimi, Quebec
?
mi
from
Chicoutimi,
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Corpus Christi, Texas 78404
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Encinitas, California 92024
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lansdale, Pennsylvania 19446
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lyndhurst, Ohio 44124
?
mi
from
Lyndhurst, OH
Click here to add this to my saved trials
Marion, Ohio 43302
?
mi
from
Marion, OH
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Muscle Shoals, Alabama 35662
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Oxon Hill, Maryland 20745
?
mi
from
Oxon Hill, MD
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
St. Petersburg, Florida 33713
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials