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Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia
Sponsor: University of Texas Southwestern Medical Center
Summary
Type I hyperlipoproteinemia (T1HLP, also known as familial chylomicronemia syndrome or FCS) is a rare diseasewhere the blood triglycerides (fats) are very high. It is caused by lack of certain enzymes and proteins in the bodythat are important in disposing circulating fats from blood. Treatment of T1HLP patients who have very high levels of blood fats (≥ 1,000 mg/dL) is challenging as conventional triglyceride-lowering medications, such as fibrates and fishoil, are ineffective. The purpose of this trial is to study the long-term efficacy and safety of orlistat for reducing blood triglyceride levels in patients with T1HLP.
Official title: Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia: a Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
8 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-01-26
Completion Date
2029-05-30
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
Orlistat
Orlistat is an inhibitor of gastric and pancreatic lipases and can reduce dietary fat absorption by 30%. Orlistat at a dose of 2 capsules (each containing 60 mg of active drug) three times a day with each meal (a total dose of 360 mg daily).
Placebo
Placebo at a dose of 2 capsules (each containing 60 mg placebo) three times a day with each meal (a total dose of 360 mg daily).
Locations (1)
UT southwestern Medical Center
Dallas, Texas, United States