The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia. This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
Unnamed facility
Miami, Florida, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Auburn, Maine, United States
Unnamed facility
Cincinnati, Ohio, United States
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Time frame: 4 weeks
Frequency of adverse events
Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Time frame: 4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Time frame: 4 weeks
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