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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594983
First Posted: May 9, 2012
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Non Familial Chylocmicronemia Syndrome (Non-FCS) Drug: LCQ908 Drug: Fenofibrate Drug: Fish Oil Drug: Placebo of LCQ908 Drug: Placebo of fenofibrate Drug: Placebo of fish oil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks [ Time Frame: Baseline, 6 weeks ]
  • Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death [ Time Frame: 12 weeks ]
  • changefrom baseline in lipids and lipoprotein profiles [ Time Frame: Baseline, 6 weeks ]

Enrollment: 58
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCQ908 1
LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
Drug: LCQ908 Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Experimental: LCQ908 2
LCQ908 once daily for 12 weeks
Drug: LCQ908 Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Experimental: LCQ908 3
LCQ908 once daily for 12 weeks
Drug: LCQ908 Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Active Comparator: Fenofibrate
Intervention Type: Drug Intervention Name: Fenofibrate
Drug: LCQ908 Drug: Fenofibrate
Fenofibrate once daily 12 weeks
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Active Comparator: Fish Oil
Fish oil once daily for 12 weeks
Drug: LCQ908 Drug: Fish Oil
Fish Oil once daily for 12 weeks
Other Name: Lovaza®
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo Comparator: Arm Label: Placebo
Intervention Type: other Intervention Name: other
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594983


  Show 32 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01594983     History of Changes
Other Study ID Numbers: CLCQ908C2201
2012-000872-40 ( EudraCT Number )
First Submitted: May 7, 2012
First Posted: May 9, 2012
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hypertriglyceridemia
Non familial Chylocmicronemia Syndrome (non-FCS)

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents