Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia
Type 1 Hyperlipoprotenemia
About this trial
This is an interventional diagnostic trial for Type 1 Hyperlipoprotenemia
Eligibility Criteria
Inclusion Criteria: Type I hyperlipoproteinemia confirmed by bi-allelic disease-causing variants in any one of the T1HLP genes (LPL, APOC2, APOA5, LMF1, GPIHBP1, or GCKR). Fasting serum triglyceride levels of greater than 1000 mg/dL. Age 8-70 years Effective contraception for males and females of childbearing age. Off orlistat for a period of 2 months. Exclusion Criteria: Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-1 protease inhibitors, retinoic acid derivatives, interferons, or l-asparaginase. On lomitapide or participating in clinical trial of volanesorsen Pregnant or lactating women Significant liver disease (elevated transaminases > 2 times upper limit of normal) Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks or 168 g per week for men) Severe anemia (hematocrit < 24%) Illicit drug use (cocaine, marijuana, LSD, etc.) Major surgery in the past three months Congestive heart failure Serum creatinine greater than 2.5 mg/dL Cancer within the past five years Gastrointestinal surgery in the past Current therapy with anti-coagulants, digoxin and anti-arrhythmics Chronic malabsorption syndromes Cholestasis Acute illnesses such as acute pancreatitis in the last 8 weeks Previous history of renal calcium oxalate stones
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Orlistat Drug
Placebo
Drug will be given orally.
Placebo will be given orally.