Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
NCT ID: NCT03193047
Last Updated: 2020-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2017-04-07
2018-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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bempedoic acid
Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
bempedoic acid 180mg
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
evolocumab
Monthly PCSK9i (evolocumab) background therapy
placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
placebo
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
evolocumab
Monthly PCSK9i (evolocumab) background therapy
Interventions
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bempedoic acid 180mg
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
placebo
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
evolocumab
Monthly PCSK9i (evolocumab) background therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
* Men and nonpregnant, nonlactating women
Exclusion Criteria
* Total fasting TG ≥500 mg/dL
* Renal dysfunction or a glomerulonephropathy; eGFR \<30 mL/min/1.73 m2
* Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
* History of type 1 or type 2 diabetes
* Uncontrolled hypertension
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
* History of hematologic or coagulation disorders
* History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
* Unexplained creatine kinase (CK) \>3 × ULN
* Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
* Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment
18 Years
ALL
No
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ron Haberman, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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L-MARC Research Center
Louisville, Kentucky, United States
Countries
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References
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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.
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.
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.
Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003 Apr 2;289(13):1681-90. doi: 10.1001/jama.289.13.1681.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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World Health Organization Fact Sheet No. 317
Other Identifiers
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1002-039
Identifier Type: -
Identifier Source: org_study_id
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