A pilot study to assess the efficacy and safety of LCQ908 alone and in combination with fenofibrate or Lovaza® in patients with severe hypertriglyceridemia

• Conditions: on Familial Chylomicronemia Syndrome (Non-FCS); MedDRA version: 14.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; Non Familial Chylomicronemia Syndrome (Non-FCS)

• Registration Number: EUCTR2012-000872-40-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-02
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
;
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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
-History of known allergy to fish/shellfish or any of the ingredients in Lovaza
-Heart transplant recipients, participants with implantable cardioverter defibrillators with ventricular tachycardia or ventricular arrhythmia, or participants with very significant cardiovascular disease, as determined by the investigator
;
-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
-History of known allergy to fish/shellfish or any of the ingredients in Lovaza
-Heart transplant recipients, participants with implantable cardioverter defibrillators with ventricular tachycardia or ventricular arrhythmia, or participants with very significant cardiovascular disease, as determined by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified