Clinical trial NCT01594983: A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Familial Chylocmicronemia Syndrome (Non-FCS)
Keywords: hypertriglyceridemia
Non familial Chylocmicronemia Syndrome (non-FCS)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in triglycerides (TG) relative to placebo at 6 weeks
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death
timeFrame: 12 weeks
measure: changefrom baseline in lipids and lipoprotein profiles
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Glendale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Encinitas
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Brandon
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ocala
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orange City
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Novartis Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: Novartis Investigative Site
state: Florida
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Oxon Hill
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Butte
country: United States
facility: Novartis Investigative Site
state: Montana
city: Cary
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Lyndhurst
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Lansdale
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Bristol
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Boerne
country: United States
facility: Novartis Investigative Site
state: Texas
city: Corpus Christi
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Chicoutimi
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: