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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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