Clinical trial NCT03067441: Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Official title: A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Keywords: hyperlipidemia
cholesterol
heterozygous familial hypercholesterolemia
atherosclerotic cardiovascular disease
ASCVD
HeFH
LDL
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.


Eligibility criteria: Inclusion Criteria:

* Successfully completed CLEAR Harmony (1002-040) parent study

Exclusion Criteria:

* Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
* Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 82
Secondary outcomes:
measure: Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 72
measure: Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 72
measure: Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From OLE Baseline ApoB at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
measure: Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78
timeFrame: Baseline; Week 52 and Week 78
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Jedidiah Clinical Research
state: Florida
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
citation: Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
citation: Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12.
citation: Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363.
citation: Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214.