A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 32 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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