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

Novartis

Status and phase: Completed; Phase 2

Conditions: Non Familial Chylocmicronemia Syndrome (Non-FCS)

Treatments: Drug: Fenofibrate; Drug: Placebo of fish oil; Drug: Placebo of fenofibrate; Drug: Fish Oil; Drug: Placebo of LCQ908; Drug: LCQ908

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594983

CLCQ908C2201

2012-000872-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 6 patient groups, including a placebo group

LCQ908 1

Experimental group

Description:

LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks

Treatment:

Drug: LCQ908

Drug: Placebo of LCQ908

Drug: Placebo of fenofibrate

Drug: Placebo of fish oil

LCQ908 2

Experimental group

Description:

LCQ908 once daily for 12 weeks

Treatment:

Drug: LCQ908

Drug: Placebo of LCQ908

Drug: Placebo of fenofibrate

Drug: Placebo of fish oil

LCQ908 3

Experimental group

Description:

LCQ908 once daily for 12 weeks

Treatment:

Drug: LCQ908

Drug: Placebo of LCQ908

Drug: Placebo of fenofibrate

Drug: Placebo of fish oil

Fenofibrate

Active Comparator group

Description:

Intervention Type: Drug Intervention Name: Fenofibrate

Treatment:

Drug: LCQ908

Drug: Placebo of LCQ908

Drug: Placebo of fish oil

Drug: Fenofibrate

Fish Oil

Active Comparator group

Description:

Fish oil once daily for 12 weeks

Treatment:

Drug: LCQ908

Drug: Placebo of LCQ908

Drug: Fish Oil

Drug: Placebo of fenofibrate

Arm Label: Placebo

Placebo Comparator group

Description:

Intervention Type: other Intervention Name: other

Treatment:

Drug: Placebo of LCQ908

Drug: Placebo of fenofibrate

Drug: Placebo of fish oil