A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
NCT ID: NCT01594983
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2012-06-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LCQ908 1
LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
LCQ908
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo of fish oil
Matching placebo of fish oil capsule
LCQ908 2
LCQ908 once daily for 12 weeks
LCQ908
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo of fish oil
Matching placebo of fish oil capsule
LCQ908 3
LCQ908 once daily for 12 weeks
LCQ908
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo of fish oil
Matching placebo of fish oil capsule
Fenofibrate
Intervention Type: Drug Intervention Name: Fenofibrate
LCQ908
Fenofibrate
Fenofibrate once daily 12 weeks
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fish oil
Matching placebo of fish oil capsule
Fish Oil
Fish oil once daily for 12 weeks
LCQ908
Fish Oil
Fish Oil once daily for 12 weeks
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Arm Label: Placebo
Intervention Type: other Intervention Name: other
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo of fish oil
Matching placebo of fish oil capsule
Interventions
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LCQ908
Fenofibrate
Fenofibrate once daily 12 weeks
Fish Oil
Fish Oil once daily for 12 weeks
Placebo of LCQ908
Matching placebo of LCQ908
Placebo of fenofibrate
Matching placebo of fenofibrate
Placebo of fish oil
Matching placebo of fish oil capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Muscle Shoals, Alabama, United States
Novartis Investigative Site
Glendale, Arizona, United States
Novartis Investigative Site
Encinitas, California, United States
Novartis Investigative Site
Colorado Springs, Colorado, United States
Novartis Investigative Site
Brandon, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Ocala, Florida, United States
Novartis Investigative Site
Orange City, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
St. Petersburg, Florida, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Oxon Hill, Maryland, United States
Novartis Investigative Site
Butte, Montana, United States
Novartis Investigative Site
Cary, North Carolina, United States
Novartis Investigative Site
Salisbury, North Carolina, United States
Novartis Investigative Site
Lyndhurst, Ohio, United States
Novartis Investigative Site
Marion, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Tulsa, Oklahoma, United States
Novartis Investigative Site
Eugene, Oregon, United States
Novartis Investigative Site
Lansdale, Pennsylvania, United States
Novartis Investigative Site
Bristol, Tennessee, United States
Novartis Investigative Site
Boerne, Texas, United States
Novartis Investigative Site
Corpus Christi, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Chicoutimi, Quebec, Canada
Novartis Investigative Site
Ste-Foy, Quebec, Canada
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Countries
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Related Links
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Results for CLCQ908C2201 from the Novartis Clinical Trials website
Other Identifiers
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2012-000872-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCQ908C2201
Identifier Type: -
Identifier Source: org_study_id