The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Unnamed facility
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
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: 8 weeks
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
Time frame: 4 weeks
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Muscle Shoals, Alabama, United States
Unnamed facility
Huntington Park, California, United States
Unnamed facility
Lomita, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Brooksville, Florida, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Jupiter, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
Winter Park, Florida, United States
Unnamed facility
Chicago, Illinois, United States
...and 24 more locations