The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Unnamed facility
Muscle Shoals, Alabama, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Jacksonville, Florida, United States
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
Time frame: 4 weeks
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia
Time frame: 4 weeks
Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol
Time frame: 4 weeks
Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia
Time frame: 4 weeks
Frequency of adverse events
Safety and tolerability 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
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Unnamed facility
Miami, Florida, United States
Unnamed facility
Winter Park, Florida, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Auburn, Maine, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Raleigh, North Carolina, United States
...and 4 more locations