Clinical trial NCT03051100: Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: hyperlididemia
LDL
cholesterol
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 63
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 triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.


Eligibility criteria: Inclusion Criteria:

* Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
* Men and nonpregnant, nonlactating women
* Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks

Exclusion Criteria:

* Fasting blood triglycerides greater than or equal to 400 mg/dL
* Body Mass Index (BMI) greater than 50 kg/m2
* History of clinically significant cardiovascular disease
* History of type 1 or type 2 diabetes

Primary outcomes:
measure: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6
timeFrame: Baseline; Week 6
Secondary outcomes:
measure: Percent Change From Baseline in Lipid Profile Parameters at Week 6
timeFrame: Baseline; Week 6
measure: Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6
timeFrame: Baseline; Week 6
measure: Number of Participants With LDL-C <70 mg/dL at Week 6
timeFrame: Week 6
measure: Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6
timeFrame: Baseline; Week 6
Other outcomes:
Locations:
city: Champaign
country: United States
facility: PMG Research of Christie Clinic
state: Illinois
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Sensenbrenner Primary Care
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Virginia Beach
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
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: Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. doi: 10.1007/s11883-016-0611-4.
citation: Thompson PD, MacDougall DE, Newton RS, Margulies JR, Hanselman JC, Orloff DG, McKenney JM, Ballantyne CM. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. J Clin Lipidol. 2016 May-Jun;10(3):556-67. doi: 10.1016/j.jacl.2015.12.025. Epub 2016 Jan 6.
citation: Ballantyne CM, McKenney JM, MacDougall DE, Margulies JR, Robinson PL, Hanselman JC, Lalwani ND. Effect of ETC-1002 on Serum Low-Density Lipoprotein Cholesterol in Hypercholesterolemic Patients Receiving Statin Therapy. Am J Cardiol. 2016 Jun 15;117(12):1928-33. doi: 10.1016/j.amjcard.2016.03.043. Epub 2016 Apr 6.
citation: Thompson PD, Rubino J, Janik MJ, MacDougall DE, McBride SJ, Margulies JR, Newton RS. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol. 2015 May-Jun;9(3):295-304. doi: 10.1016/j.jacl.2015.03.003. Epub 2015 Mar 19.