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

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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
Glendale, Arizona 85308
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Boerne, Texas 78006
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Boerne, TX
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Brandon, Florida 33511
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Brandon, FL
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Bristol, Tennessee 37620
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Bristol, TN
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Butte, Montana 59701
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Butte, MT
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Cary, North Carolina 27511
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Cary, NC
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Chicoutimi, Quebec
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Chicoutimi,
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Corpus Christi, Texas 78404
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Corpus Christi, TX
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Encinitas, California 92024
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Encinitas, CA
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Eugene, Oregon 97401
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Eugene, OR
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Houston, Texas 77030
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Houston, TX
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Lansdale, Pennsylvania 19446
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Lansdale, PA
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Louisville, Kentucky 40202
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Louisville, KY
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Lyndhurst, Ohio 44124
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Lyndhurst, OH
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Marion, Ohio 43302
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Marion, OH
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Miami, Florida 33136
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Miami, FL
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Muscle Shoals, Alabama 35662
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Muscle Shoals, AL
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Ocala, Florida 34471
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Ocala, FL
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Orange City, Florida 32763
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Orange City, FL
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Orlando, Florida 32806
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Orlando, FL
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Oxon Hill, Maryland 20745
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Oxon Hill, MD
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Port Orange, Florida 32127
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Port Orange, FL
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Salisbury, North Carolina 28144
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Salisbury, NC
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St. Petersburg, Florida 33713
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St. Petersburg, FL
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Tulsa, Oklahoma 74104
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Tulsa, OK
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