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 |
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.
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
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