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

Phase 2

Completed

• Conditions: Non Familial Chylocmicronemia Syndrome (Non-FCS)
• Interventions: Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Fenofibrate; Drug: Fish Oil; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil

• Registration Number: NCT01594983
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Study Start: 2012-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-10
• Disposition First Submitted: 2015-10-05
• Disposition First Submitted QC: 2015-10-05
• Disposition First Posted: 2015-10-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCQ908 2	LCQ908	LCQ908 once daily for 12 weeks
LCQ908 2	Placebo of LCQ908	LCQ908 once daily for 12 weeks
LCQ908 2	Placebo of fenofibrate	LCQ908 once daily for 12 weeks
LCQ908 2	Placebo of fish oil	LCQ908 once daily for 12 weeks
LCQ908 3	LCQ908	LCQ908 once daily for 12 weeks
LCQ908 1	LCQ908	LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
LCQ908 1	Placebo of LCQ908	LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
LCQ908 1	Placebo of fish oil	LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
LCQ908 3	Placebo of LCQ908	LCQ908 once daily for 12 weeks
LCQ908 3	Placebo of fenofibrate	LCQ908 once daily for 12 weeks
LCQ908 3	Placebo of fish oil	LCQ908 once daily for 12 weeks
Fenofibrate	LCQ908	Intervention Type: Drug Intervention Name: Fenofibrate
Fenofibrate	Fenofibrate	Intervention Type: Drug Intervention Name: Fenofibrate
Fenofibrate	Placebo of LCQ908	Intervention Type: Drug Intervention Name: Fenofibrate
Fenofibrate	Placebo of fish oil	Intervention Type: Drug Intervention Name: Fenofibrate
Fish Oil	LCQ908	Fish oil once daily for 12 weeks
Fish Oil	Placebo of fenofibrate	Fish oil once daily for 12 weeks
Arm Label: Placebo	Placebo of LCQ908	Intervention Type: other Intervention Name: other
Fish Oil	Placebo of LCQ908	Fish oil once daily for 12 weeks
Arm Label: Placebo	Placebo of fenofibrate	Intervention Type: other Intervention Name: other
Arm Label: Placebo	Placebo of fish oil	Intervention Type: other Intervention Name: other
LCQ908 1	Placebo of fenofibrate	LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
Fish Oil	Fish Oil	Fish oil once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Moscow, Russian Federation