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

Primary Purpose

Hyperlipoproteinemia

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
LCQ908
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipoproteinemia focused on measuring Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LCQ908

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Fasting and postprandial plasma triglycerides

Secondary Outcome Measures

Blood concentration to characterize LCQ908 kinetics
Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)

Full Information

First Posted
June 9, 2010
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01146522
Brief Title
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipoproteinemia
Keywords
Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCQ908
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LCQ908
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)
Time Frame
after 3 weeks of treatment with each dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25889044
Citation
Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7263
Description
Results for CLCQ908A2212 from the Novartis Clinical Trials website

Learn more about this trial

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

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