Non Familial Chylocmicronemia Syndrome (Non-FCS) Clinical Trial
Official title:
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
| Verified date | October 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novartis Investigative Site | Chicoutimi | Quebec |
| Canada | Novartis Investigative Site | Ste-Foy | Quebec |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| United States | Novartis Investigative Site | Boerne | Texas |
| United States | Novartis Investigative Site | Brandon | Florida |
| United States | Novartis Investigative Site | Bristol | Tennessee |
| United States | Novartis Investigative Site | Butte | Montana |
| United States | Novartis Investigative Site | Cary | North Carolina |
| United States | Novartis Investigative Site | Colorado Springs | Colorado |
| United States | Novartis Investigative Site | Corpus Christi | Texas |
| United States | Novartis Investigative Site | Encinitas | California |
| United States | Novartis Investigative Site | Eugene | Oregon |
| United States | Novartis Investigative Site | Glendale | Arizona |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Lansdale | Pennsylvania |
| United States | Novartis Investigative Site | Louisville | Kentucky |
| United States | Novartis Investigative Site | Lyndhurst | Ohio |
| United States | Novartis Investigative Site | Marion | Ohio |
| United States | Novartis Investigative Site | Miami | Florida |
| United States | Novartis Investigative Site | Muscle Shoals | Alabama |
| United States | Novartis Investigative Site | Ocala | Florida |
| 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 | Orange City | Florida |
| United States | Novartis Investigative Site | Orlando | Florida |
| United States | Novartis Investigative Site | Oxon Hill | Maryland |
| United States | Novartis Investigative Site | Port Orange | Florida |
| United States | Novartis Investigative Site | Saint Petersburg | Florida |
| United States | Novartis Investigative Site | Salisbury | North Carolina |
| United States | Novartis Investigative Site | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Canada, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in triglycerides (TG) relative to placebo at 6 weeks | The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks. | Baseline, 6 weeks | |
| Secondary | Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks | Baseline, 12 weeks | ||
| Secondary | Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks | Baseline, 6 weeks | ||
| Secondary | Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks | Baseline, 12 weeks | ||
| Secondary | Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death | 12 weeks | ||
| Secondary | changefrom baseline in lipids and lipoprotein profiles | Baseline, 6 weeks |