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Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 9, 2010
Last updated: December 28, 2012
Last verified: December 2012
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

Condition Intervention Phase
Hyperlipoproteinemia Drug: LCQ908 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Fasting and postprandial plasma triglycerides [ Time Frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment) ]

Secondary Outcome Measures:
  • Blood concentration to characterize LCQ908 kinetics [ Time Frame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose ]
  • Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) [ Time Frame: after 3 weeks of treatment with each dose ]

Enrollment: 8
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCQ908 Drug: LCQ908
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
  • Non breast feeding women.
  • Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

  • uncontrolled type 1 or type 2 diabetes mellitus,
  • active pancreatitis (the month prior to study start),
  • history of drug or alcohol abuse within the 12 months prior to dosing,
  • or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its identifier: NCT01146522

Novartis Investigative Site
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01146522     History of Changes
Other Study ID Numbers: CLCQ908A2212
Study First Received: June 9, 2010
Last Updated: December 28, 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Familial hyperchylomicronemia
Lipoprotein lipase deficiency
Hyperlipoproteinemia associated with lipoprotein lipase deficiency

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on August 17, 2017