LDL-C Reductions Surpass Target of LDL-C NeutralityThe trial's key secondary endpoint was to demonstrate a lack of elevation of LDL-C in order to avoid offset to the primary target of cholesterol lowering therapy. The trial's non-inferiority criterion for LDL-C was met at both AMR101 doses. The upper confidence boundaries for both doses were below the pre-specified +6% LDL-C threshold limit. In fact, at the 4 gram dose the upper confidence boundary was below zero (-1.7%) and at the 2 gram dose the upper confidence boundary was close to zero (0.05%). Moreover, for the 4 grams per day AMR101 group, LDL-C decreased significantly by 6.2% from baseline versus placebo, demonstrating superiority over placebo (p=0.0067). For the 2 grams per day group, LDL-C decreased by 3.6% from baseline versus placebo (p=0.0867).
Amarin's AMR101 Phase 3 ANCHOR Trial Meets All Primary And Secondary Endpoints With Statistically Significant Reductions In Triglycerides At Both 4 Gram And 2 Gram Doses And Statistically Significant Decrease In LDL-C
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