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

Phase 1

Completed

• Conditions: Hyperlipoproteinemia
• Interventions: Drug: Placebo; Drug: LCQ908

• Registration Number: NCT01146522
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-11-30
• Disposition First Submitted QC: 2012-11-30
• Status Verified: 2012-12
• Disposition First Posted: 2012-12-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LCQ908	LCQ908	-

Primary Outcome Measures

Name	Time	Method
Fasting and postprandial plasma triglycerides	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

Name	Time	Method
Blood concentration to characterize LCQ908 kinetics	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)	after 3 weeks of treatment with each dose

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇦 Quebec, Canada