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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Triglycerides

Drug Information available for: Fish oil Fenofibrate Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Omega-3-acid ethyl esters Lovaza

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in triglycerides (TG) relative to placebo at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
changefrom baseline in lipids and lipoprotein profiles [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594983

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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
Study First Received:	May 7, 2012
Last Updated:	October 5, 2015
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Novartis:


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

ClinicalTrials.gov processed this record on September 28, 2016