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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

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.
 
ClinicalTrials.gov Identifier: NCT01594983
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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


Locations
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United States, Alabama
Novartis Investigative Site
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Novartis Investigative Site
Glendale, Arizona, United States, 85306
United States, California
Novartis Investigative Site
Encinitas, California, United States, 92024-1332
United States, Colorado
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80906
United States, Florida
Novartis Investigative Site
Brandon, Florida, United States, 33511
Novartis Investigative Site
Miami, Florida, United States, 33156
Novartis Investigative Site
Ocala, Florida, United States, 34471
Novartis Investigative Site
Orange City, Florida, United States, 32763
Novartis Investigative Site
Orlando, Florida, United States, 32806
Novartis Investigative Site
Port Orange, Florida, United States, 32127
Novartis Investigative Site
St. Petersburg, Florida, United States, 33709
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40213
United States, Maryland
Novartis Investigative Site
Oxon Hill, Maryland, United States, 20745
United States, Montana
Novartis Investigative Site
Butte, Montana, United States, 59701
United States, North Carolina
Novartis Investigative Site
Cary, North Carolina, United States, 27518
Novartis Investigative Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
Novartis Investigative Site
Lyndhurst, Ohio, United States, 44124
Novartis Investigative Site
Marion, Ohio, United States, 43302
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73103
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73135
Novartis Investigative Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Novartis Investigative Site
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Novartis Investigative Site
Lansdale, Pennsylvania, United States, 19446
United States, Tennessee
Novartis Investigative Site
Bristol, Tennessee, United States, 37620
United States, Texas
Novartis Investigative Site
Boerne, Texas, United States, 78006
Novartis Investigative Site
Corpus Christi, Texas, United States, 78404
Novartis Investigative Site
Houston, Texas, United States, 77074
Canada, Quebec
Novartis Investigative Site
Chicoutimi, Quebec, Canada, G7H 5H6
Novartis Investigative Site
Ste-Foy, Quebec, Canada, G1V4M6
Russian Federation
Novartis Investigative Site
Moscow, Russia, Russian Federation, 129090
Novartis Investigative Site
Moscow, Russian Federation, 121552
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01594983    
Other Study ID Numbers: CLCQ908C2201
2012-000872-40 ( EudraCT Number )
First Posted: May 9, 2012    Key Record Dates
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:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents