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Completed

NCT Number: NCT01146522

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

This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

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Key information

Conditions

Hyperlipoproteinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type I Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site

Québec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCQ908

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)

    Time frame: after 3 weeks of treatment with each dose

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2010
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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