A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
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| ClinicalTrials.gov Identifier: NCT01594983 |
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Recruitment Status :
Completed
First Posted : May 9, 2012
Last Update Posted : October 28, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Triglycerides
| Arm | Intervention/treatment |
|---|---|
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Experimental: LCQ908 1
LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
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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 |
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Experimental: LCQ908 2
LCQ908 once daily for 12 weeks
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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 |
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Experimental: LCQ908 3
LCQ908 once daily for 12 weeks
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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 |
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Active Comparator: Fenofibrate
Intervention Type: Drug Intervention Name: Fenofibrate
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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 |
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Active Comparator: Fish Oil
Fish oil once daily for 12 weeks
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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 |
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Placebo Comparator: Arm Label: Placebo
Intervention Type: other Intervention Name: other
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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 :
- 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 ]
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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
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01594983 History of Changes |
| 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 ):
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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 |