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

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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146522

Enrollment

Registered

2010-06-17

Start date

2010-05-31

Completion date

2011-10-31

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipoproteinemia

Keywords

Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency

Brief summary

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

Interventions

DRUGLCQ908

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026