Clinical trial NCT02988115: Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Statin Adverse Reaction
Keywords: hyperlipidemia
cholesterol
familial hypercholesterolemia
atherosclerotic cardiovascular disease
ASCVD
HeFH
LDL
statin intolerance
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.


Eligibility criteria: Inclusion Criteria:

* Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
* Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
* Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

* Total fasting triglyceride ≥500 mg/dL
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50 kg/m2
* Significant cardiovascular disease or cardiovascular event in the past 3 months

Primary outcomes:
measure: Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Percent Change From Baseline in LDL-C at Week 24
timeFrame: Baseline; Week 24
measure: Percent Change From Baseline in the Lipid Profile at Week 12
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12
timeFrame: Baseline; Week 12
measure: Absolute Change From Baseline in LDL-C at Week 12 and Week 24
timeFrame: Baseline; Week 12; Week 24
Other outcomes:
Locations:
city: Gilbert
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: Daytona Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miami
country: United States
facility: Site 1
state: Florida
city: Miami
country: United States
facility: Site 2
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Meridian
country: United States
state: Idaho
city: Evanston
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Waterloo
country: United States
state: Iowa
city: Monroe
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Tupelo
country: United States
state: Mississippi
city: Lincoln
country: United States
state: Nebraska
city: Somerset
country: United States
state: New Jersey
city: Binghamton
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: New Windsor
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Mount Airy
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Maumee
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Beaver
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Cumberland
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Dallas
country: United States
facility: Site 1
state: Texas
city: Dallas
country: United States
facility: Site 2
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Hampton
country: United States
state: Virginia
city: Kenosha
country: United States
state: Wisconsin
city: Brossard
country: Canada
city: Chicoutimi
country: Canada
city: Gatineau
country: Canada
city: London
country: Canada
city: Longueuil
country: Canada
city: Mirabel
country: Canada
city: Montréal
country: Canada
city: Newmarket
country: Canada
city: Oakville
country: Canada
city: Peterborough
country: Canada
city: Pointe-Claire
country: Canada
city: Saint-Jérôme
country: Canada
city: Sarnia
country: Canada
city: Toronto
country: Canada
city: Victoriaville
country: Canada
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Ron Haberman, MD
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: Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
citation: Eckel RH. Approach to the patient who is intolerant of statin therapy. J Clin Endocrinol Metab. 2010 May;95(5):2015-22. doi: 10.1210/jc.2009-2689.
citation: Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005 Jan 6;352(1):20-8. doi: 10.1056/NEJMoa042378.
citation: Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015 Aug 14;36(31):2110-2118. doi: 10.1093/eurheartj/ehv182. Epub 2015 May 20.
citation: Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2.
citation: Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314.
citation: Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.