LAPLACE-TIMI 57 Study DesignLAPLACE-TIMI 57 ( LDL-C Assessment with P CSK9 monoclona L Antibody inhibition Combined with statin th Erapy – Thrombolysis In Myocardial Infarction-57) is a Phase 2 randomized, double-blind, dose-ranging, placebo-controlled study that included eight treatment arms to evaluate the efficacy, safety and tolerability of AMG 145, administered subcutaneously, in 629 patients at risk for cardiovascular disease with LDL-C > 85 mg/dL when added to a stable dose of statin with or without ezetimibe. Treatment arms included AMG 145 (70 mg, 105 mg and 140 mg) versus placebo Q2W and AMG 145 (280 mg, 350 mg and 420 mg) versus placebo Q4W. The primary endpoint of the study was the percent change from baseline in LDL-C, measured by preparative ultracentrifugation, at week 12. Secondary efficacy endpoints included the absolute change from baseline in LDL-C at week 12 and the percentage changes from baseline to week 12 in non-high-density lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio and ApoB/ApoA1 ratio.
MENDEL Study Design
onoclonal Antibody Against PCSK9 to Reduce
levated LDL-C in Patients Currently
rug Therapy For
ipid Levels) is a Phase 2 randomized, multi-center, double-blind, controlled trial designed to evaluate the efficacy, safety and tolerability of AMG 145 in 406 patients with low cardiovascular risk (LDL-C
100 mg/dL and < 190 mg/dL) who were not receiving statin therapy. AMG 145 was evaluated across nine treatment groups, including AMG 145 at 70 mg, 105 mg and 140 mg dosed Q2W compared to placebo Q2W; and AMG 145 at 280 mg, 350 mg and 420 mg dosed Q4W compared to placebo Q4W; or daily ezetimibe 10 mg. The primary endpoint was percentage change from baseline in LDL-C, measured by preparative ultracentrifugation, at week 12. Secondary efficacy endpoints included the absolute change from baseline in LDL-C at week 12 and the percentage changes from baseline at week 12 in non-high-density lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio and ApoB/ApoA1 ratio.
Amgen will hold an analyst/investor event on
Tuesday, Nov. 6
7:00 p.m. Pacific Standard Time
to discuss data presented at AHA. A webcast of the event can be found on Amgen's website at
, under Investors. The audio webcast will be archived and available for replay for at least 72 hours.
About AMG 145
AMG 145 is a fully human monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver's ability to remove LDL-C from the blood and thereby causes bad cholesterol to increase. AMG 145, developed by Amgen scientists, binds to PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL receptors in the liver. Without PCSK9 bound to them, the LDL receptors can take up and remove LDL-C from the blood, recycle and remain available for binding additional LDL-C. The Amgen Phase 2 program for AMG 145 enrolled more than 2,000 patients across seven studies to evaluate the effects of AMG 145 across multiple patient populations who may benefit from additional cholesterol lowering treatment options. The Phase 2 program is evaluating the treatment of hyperlipidemia with AMG 145 in combination with statins, in patients with hyperlipidemia who cannot tolerate statins, as a stand-alone treatment in patients with hyperlipidemia, and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous and homozygous familial hypercholesterolemia.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. For more information, visit
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