A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

A Multicenter, Randomized, Active Comparator, Placebo Controlled, Double-blind Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594983

Enrollment

Registered

2012-05-09

Start date

2012-06-30

Completion date

2013-07-31

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

Non Familial Chylocmicronemia Syndrome (Non-FCS)

Keywords

hypertriglyceridemia, Non familial Chylocmicronemia Syndrome (non-FCS)

Brief summary

This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.

Interventions

DRUGLCQ908

DRUGFenofibrate

Fenofibrate once daily 12 weeks

DRUGFish Oil

Fish Oil once daily for 12 weeks

DRUGPlacebo of LCQ908

Matching placebo of LCQ908

DRUGPlacebo of fenofibrate

Matching placebo of fenofibrate

DRUGPlacebo of fish oil

Matching placebo of fish oil capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female subjects ages \>18 years of age, inclusive. * History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state. * Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.

Exclusion criteria

* Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening. * Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening. * Pancreatitis within 3 months prior to screening. * Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at screening) * BMI \> 40 or history of bariatric surgery. * Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive. * Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2 Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks	Baseline, 6 weeks	The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.

Secondary

Measure	Time frame
Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks	Baseline, 12 weeks
Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks	Baseline, 6 weeks
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks	Baseline, 12 weeks
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death	12 weeks
changefrom baseline in lipids and lipoprotein profiles	Baseline, 6 weeks

Countries

Canada, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026