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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non Familial Chylocmicronemia Syndrome (Non-FCS)

In brief

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.

Key facts

Study ID

NCT01594983

Run by

Novartis Pharmaceuticals

People needed

58

Starts

2012-06-01

Expected to finish

2013-07-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Glendale, Arizona, United States
• Novartis Investigative Site — Encinitas, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Brandon, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Orange City, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Port Orange, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Oxon Hill, Maryland, United States
• Novartis Investigative Site — Butte, Montana, United States
• Novartis Investigative Site — Cary, North Carolina, United States
• Novartis Investigative Site — Salisbury, North Carolina, United States
• Novartis Investigative Site — Lyndhurst, Ohio, United States
• Novartis Investigative Site — Marion, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Tulsa, Oklahoma, United States
• Novartis Investigative Site — Eugene, Oregon, United States
• Novartis Investigative Site — Lansdale, Pennsylvania, United States
• Novartis Investigative Site — Bristol, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.