NEXLETOL provided significant LDL-C reduction regardless of patients’ maximally tolerated statin dose1-3

CLEAR Harmony

Results showed significant 18% mean LDL-C reduction compared to placebo, for extra control on top of a statin1

clear harmony

In a subgroup of patients taking low- to moderate-intensity statins2*

20%

MEAN LDL-C Reduction

Compared to placebo at 12 weeks

NEXLETOL: -18% (n=706); placebo: 2% (n=362) (P<0.001)

In a subgroup of patients taking high-intensity statins2‡

17%

MEAN LDL-C Reduction

Compared to placebo at 12 weeks

NEXLETOL: -16% (n=718); placebo: 1% (n=363) (P<0.001)

CLEAR Harmony (Study 1) was a 52-week, randomized, double-blind, Phase 3 trial in 2,230 patients randomized 2:1 to receive NEXLETOL (n=1,488) or placebo (n=742). CLEAR Harmony included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was added to whatever patient’s maximally tolerated statin dose was, either alone or with other lipid-lowering therapies. Primary endpoint was general safety, which included adverse events, clinical safety laboratories, physical examinations, vital signs, and electrocardiogram. Secondary endpoint was % change from baseline to Week 12 in LDL-C.2

For additional information, including baseline patient characteristics, review the CLEAR Harmony study design.

CLEAR Wisdom

Results showed significant 17% mean LDL-C reduction compared to placebo, for extra control on top of a statin1

clear harmony

In a subgroup of patients taking low- to moderate-intensity statins3*

19%

MEAN LDL-C Reduction

Compared to placebo at 12 weeks

NEXLETOL: -17% (n=225); placebo: 2% (n=118) (P<0.001)

In a subgroup of patients taking high-intensity statins3‡

17%

MEAN LDL-C Reduction

Compared to placebo at 12 weeks

NEXLETOL: -14% (n=273); placebo: 3% (n=135) (P<0.001)

CLEAR Wisdom (Study 2) was a 52-week, randomized, double-blind, Phase 3 trial in 779 patients randomized 2:1 to receive NEXLETOL (n=522) or placebo (n=257). CLEAR Wisdom included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was added to whatever patient’s maximally tolerated statin dose was (including no statin at all) either alone or with other lipid-lowering therapies. Primary endpoint was % change from baseline to Week 12 in LDL-C. Secondary endpoints were % 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, and absolute change from baseline to Weeks 12 and 24 in LDL-C.3

*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. Data on file. CSR 1002-047. January 2019.