The objectives of this study is * To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment. * To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
Percent change in triglycerides from baseline to week 12
Time frame: from baseline to Week 12
Change in HDL-C from baseline to Week 12
Time frame: from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
Time frame: from baseline to Week 12
Change in LDL-C from baseline to Week 12
Time frame: from baseline to week 12
Change in VLDL-C from baseline to Week 12
Time frame: from baseline to week 12
Change in total cholesterol from baseline to Week 12
Time frame: from baseline to week 12
Change in ApoA1 from baseline to Week 12
Time frame: from baseline to Week 12
Change in Apo B from baseline to Week 12
Time frame: from baseline to week 12
Change in insulin from baseline to Week 12
Time frame: from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12
Time frame: from baseline to Week 12
Change in HbA1c from baseline to Week 12
Time frame: from baseline to Week 12
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Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Terence Hart, MD
Muscle Shoals, Alabama, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
National Research Institute - East 118
Los Angeles, California, United States
Research Across America - Santa Ana
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
...and 29 more locations
Change in insulin resistance (HOMA) from baseline to Week 12
Time frame: from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12
Time frame: from baseline to Week 12
Change in hsCRP from baseline to Week 12
Time frame: from baseline to Week 12
Change in red blood cell content of EPA and DHA from baseline to Week 12;
Time frame: from baseline to Week 12;