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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051100
• Other study ID #: 1002-038
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2017
• Est. completion date: July 5, 2017

Study information

• Verified date: March 2020
• Source: Esperion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 5, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Bempedoic acid 180mg
bempedoic acid 180 mg
• Ezetimibe 10mg
ezetimibe 10 mg
• Atorvastatin 20mg
atorvastatin 20 mg

Other:
• Placebo
placebo

Locations

Country	Name	City	State
United States	PMG Research of Cary	Cary	North Carolina
United States	PMG Research of Christie Clinic	Champaign	Illinois
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Sensenbrenner Primary Care	Charlotte	North Carolina
United States	PMG Research of Hickory	Hickory	North Carolina
United States	PMG Research of Charleston	Mount Pleasant	South Carolina
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	PMG Research of Rocky Mount	Rocky Mount	North Carolina
United States	PMG Research Salisbury	Salisbury	North Carolina
United States	Hampton Roads Center for Clinical Research	Virginia Beach	Virginia
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6	Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.	Baseline; Week 6
Secondary	Percent Change From Baseline in Lipid Profile Parameters at Week 6	Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Baseline apolipoprotein B (apoB) was measured only at predose/Day 1. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing values were imputed using LOCF, with only post-Baseline values carried forward. non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol.	Baseline; Week 6
Secondary	Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6	Percent change is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the predose Day 1/Week 0 (Treatment Visit 1) value. If only one value is available either at Week -1 (Screening Visit 2) or Week 0 (Treatment Visit 1), then that value is used as Baseline. Missing values were imputed using LOCF, with only post-Baseline values carried forward.	Baseline; Week 6
Secondary	Number of Participants With LDL-C <70 mg/dL at Week 6	Analysis was based on LOCF values. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.	Week 6
Secondary	Number of Participants With LDL-C Reduction =50% From Baseline at Week 6	If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.	Baseline; Week 6