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ARTICLE | Clinical News

ETC-1002: Final Phase II data

May 13, 2013 7:00 AM UTC

Final data from a double-blind, U.S. Phase II trial in 60 Type II diabetics with hypercholesterolemia showed that once-daily 80 mg oral ETC-1002 for 2 weeks followed by once-daily 120 mg oral ETC-1002 for an additional 2 weeks met the primary endpoint of reducing mean LDL-C from baseline to week 4 vs. placebo (43% vs. 3%, p<0.0001). Additionally, ETC-1002 significantly reduced mean LDL-C by 32% from baseline to week 2 vs. 6% for placebo (p<0.0001). ETC-1002 also significantly reduced non-HDL-C by 32% from baseline to week 4 vs. 1% for placebo (p=0.0001). Furthermore, ETC-1002 significantly reduced high sensitivity C-reactive protein (hsCRP) levels and blood pressure vs. placebo, but had neutral effects on other lipids, including triglycerides and HDL-C. ETC-1002 was well tolerated with headache, hyperglycemia, constipation, arthralgia, dry eye and viral upper respiratory tract infection reported as the most common adverse events. Data were presented at the Arteriosclerosis, Thrombosis and Vascular Biology meeting in Lake Buena Vista. ...