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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Placebo; Drug: Bempedoic acid 180mg; Drug: Ezetimibe 10mg; Drug: Atorvastatin 20mg

• Registration Number: NCT03051100
• Lead Sponsor: Esperion Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-13
• Primary Completion: 2017-06-01
• Study Completion: 2017-07-05
• Disposition First Submitted: 2018-07-23
• Disposition First Submitted QC: 2018-07-23
• Disposition First Posted: 2018-07-26
• Status Verified: 2020-03
• Results First Submitted: 2020-03-20
• Results First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-20
• Results First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triplet Therapy	Ezetimibe 10mg	Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
Triplet Therapy	Atorvastatin 20mg	Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
placebo	Placebo	Matching placebos taken orally, daily.
Triplet Therapy	Bempedoic acid 180mg	Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6	Baseline; 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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lipid Profile Parameters at Week 6	Baseline; 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.
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6	Baseline; 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.
Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6	Baseline; 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.
Number of Participants With LDL-C <70 mg/dL at Week 6	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.

Trial Locations

Locations (11)

PMG Research of Rocky Mount; 🇺🇸 Rocky Mount, North Carolina, United States

PMG Research of Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Hampton Roads Center for Clinical Research; 🇺🇸 Virginia Beach, Virginia, United States

Sensenbrenner Primary Care; 🇺🇸 Charlotte, North Carolina, United States

PMG Research of Christie Clinic; 🇺🇸 Champaign, Illinois, United States

PMG Research of Hickory; 🇺🇸 Hickory, North Carolina, United States

PMG Research of Charleston; 🇺🇸 Mount Pleasant, South Carolina, United States

PMG Research Salisbury; 🇺🇸 Salisbury, North Carolina, United States

PMG Research of Cary; 🇺🇸 Cary, North Carolina, United States

PMG Research of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

PMG Research of Wilmington; 🇺🇸 Wilmington, North Carolina, United States