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
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fenofibrate

Criteria

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