053 Trial

Evaluated NEXLIZET as add-on to patients' maximally tolerated statin dose1

This was a 12-week, randomized, double-blind, Phase 3 trial of over 300 patients requiring additional LDL-C reduction.1,2

053 Trial (N=301)1

 

NEXLIZET (n=86), NEXLETOL (n=88), ezetimibe (n=86), placebo (n=41); 2:2:2:1 randomization1

 

Included patients aged ≥18 years with fasting LDL-C ≥100 mg/dL if they had ASCVD and/or HeFH, or ≥130 mg/dL if they had multiple cardiovascular disease risk factors2

 

NEXLIZET added to patients’ maximally tolerated statin dose (including no statin at all), either alone or with other lipid-lowering therapies2

 

Primary Endpoint2:

  • % change from baseline to Week 12 in LDL-C

Secondary Endpoint2:

  • % change from baseline to Week 12 in hsCRP, non-HDL-C, total C, apolipoprotein B, HDL-C, and TGs

Pivotal trial enrolled a range of patients with cardiovascular risk1

Baseline Patient Characteristics
Mean LDL-C 149.7 mg/dL
History of ASCVD and/or HeFH 62.0%
Using concomitant statins 65.0%
Using high-intensity statins* 35.0%
Leaf

*High-intensity statins: atorvastatin 40 mg to 80 mg; rosuvastatin 20 mg to 40 mg.2

LDL-C=low-density lipoprotein cholesterol; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; hsCRP=high-sensitivity C-reactive protein; non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; TGs=triglycerides.

References: 1. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 2. Data on file. CSR 1002-053. January 2019.