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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01594983
First received: May 7, 2012
Last updated: November 21, 2013
Last verified: November 2013
  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:


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

  Show 32 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( 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: November 21, 2013
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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014