Two trials with over 3,000 patients requiring additional LDL-C reduction1

CLEAR Harmony (Study 1)

Evaluated the safety and efficacy of NEXLETOL as add-on to patients’ maximally tolerated statin dose1-3

This was a 52-week, randomized, double-blind, placebo-controlled, Phase 3 trial of 2,230 patients with ASCVD and/or HeFH primarily taking moderate- to high-intensity statins.1,2

CLEAR Harmony (N=2,230)1

 

NEXLETOL (n=1,488), placebo (n=742); 2:1 randomization1

 

Included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL2

 

NEXLETOL added to patients' maximally tolerated statin dose, either alone or with other lipid-lowering therapies2

 

Primary Endpoint2:

  • General safety (including adverse events, clinical safety laboratories, physical examinations, vital signs, and electrocardiogram)

Select Secondary Endpoint2:

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

CLEAR Harmony enrolled a spectrum of patients2

Baseline Patient Characteristics CLEAR HARMONY
Mean LDL-C 103.2 mg/dL
History of ASCVD 97.6%
History of diabetes 28.6%
HeFH, with or without ASCVD 3.5%
Using concomitant statins 99.9%
Using low-intensity statins* 6.6%
Using moderate-intensity statins† 43.5%
Using high-intensity statins‡ 49.9%
Leaf

CLEAR Wisdom (Study 2)

Evaluated the efficacy and safety of NEXLETOL as add-on to patients’ maximally tolerated statin dose1,4,5

This was a 52-week, randomized, double-blind, placebo-controlled, Phase 3 trial of 779 patients with ASCVD and/or HeFH primarily taking moderate- to high-intensity statins.1,4

CLEAR Wisdom (N=779)1

 

NEXLETOL (n=522), placebo (n=257); 2:1 randomization1

 

Included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL4

 

NEXLETOL was added to patients' maximally tolerated statin dose (including no statin at all) either alone or with other lipid-lowering therapies4

 

Primary Endpoint4:

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

Secondary Endpoints4:

  • % change from baseline to Week 24 in LDL-C
  • % change from baseline to Week 12 in non-HDL-C, total C, apolipoprotein B, and hsCRP
  • Absolute change from baseline to Weeks 12 and 24 in LDL-C

CLEAR Wisdom enrolled a spectrum of patients4

Baseline Patient Characteristics CLEAR WISDOM
Mean LDL-C 120.4 mg/dL
History of ASCVD 94.5%
History of diabetes 30.3%
HeFH, with or without ASCVD 5.5%
Using concomitant statins 89.6%
Using low-intensity statins* 15.1%
Using moderate-intensity statins† 31.8%
Using high-intensity statins‡ 53.0%
Leaf

*Low-intensity statins: simvastatin 10 mg; pravastatin 10 mg to 20 mg; lovastatin 20 mg; fluvastatin 20 mg to 40 mg; pitavastatin 1 mg. Low-intensity statins also included those patients taking low-dose statins using an alternate regimen (ie, every other day, or for a specified number of times per week) and those unable to tolerate any statin at any dose.

Moderate-intensity statins: atorvastatin 10 mg to 20 mg; rosuvastatin 5 mg to 10 mg; simvastatin 20 mg to 40 mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg to 4 mg.

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

LDL-C=low-density lipoprotein cholesterol; CLEAR=Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; hsCRP=high-sensitivity C-reactive protein.

References: 1. NEXLETOL. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 2. Data on file. CSR 1002-040. October 2018. 3. Ray KK, Bays HE, Catapano AL, et al. Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med. 2019;380(11):1022-1032. 4. Data on file. CSR 1002-047. January 2019. 5. Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of bempedoic acid vs placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at high risk for cardiovascular disease: the CLEAR Wisdom randomized clinical trial. JAMA. 2019;322(18):1780-1788.