Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
49
hypercholesterolemia agent
Research Site
Jacksonville, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Louisville, Kentucky, United States
Assessment of the Pharmacodynamic Effect of CIVI 007
Percent change from baseline in PCSK9
Time frame: Baseline, D29, D57, D85
Assessment of the Lipid Efficacy of CIVI 007
Percent change from baseline in LDL-C
Time frame: Baseline, Day 29, Day 57, Day 85
Assessment of CIVI 007 Adverse Events (AEs)
Incidence of any drug-related AEs
Time frame: Baseline through 2 month follow-up
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Research Site
Cincinnati, Ohio, United States
Research Site
Munroe Falls, Ohio, United States
Research Site
San Antonio, Texas, United States