A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibra… (NCT01594983) | Clinical Trial Compass
CompletedPhase 2
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
United States58 participantsStarted 2012-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks