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Completed

NCT Number: 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

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.

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Key information

Conditions

Non Familial Chylocmicronemia Syndrome (Non-FCS) Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Chicoutimi, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCQ908

Drug

fenofibrate

Drug

Fenofibrate once daily 12 weeks

Fish oil

Drug

Fish Oil once daily for 12 weeks

Other names: Lovaza®

Placebo of LCQ908

Drug

Matching placebo of LCQ908

Placebo of fenofibrate

Drug

Matching placebo of fenofibrate

Placebo of fish oil

Drug

Matching placebo of fish oil capsule

Primary outcomes

  1. Change from baseline in triglycerides (TG) relative to placebo at 6 weeks

    Time frame: Baseline, 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.

Secondary outcomes

  1. Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks

    Time frame: Baseline, 12 weeks

  2. Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks

    Time frame: Baseline, 6 weeks

  3. Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks

    Time frame: Baseline, 12 weeks

  4. Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death

    Time frame: 12 weeks

  5. changefrom baseline in lipids and lipoprotein profiles

    Time frame: Baseline, 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 2012
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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