- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03193047
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
March 20, 2020 updated by: Esperion Therapeutics, Inc.
A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40213
- L-MARC Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years or legal age of majority depending on regional law
- Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
- Men and nonpregnant, nonlactating women
Exclusion Criteria:
- Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bempedoic acid
Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
|
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
Other Names:
Monthly PCSK9i (evolocumab) background therapy
Other Names:
|
Placebo Comparator: placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
|
Monthly PCSK9i (evolocumab) background therapy
Other Names:
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
Time Frame: Baseline; Month 2
|
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 average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments).
If only one value was available, then that single value was used at Baseline.
Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate.
Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
|
Baseline; Month 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in LDL-C at Month 1
Time Frame: Baseline; Month 1
|
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 average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments).
If only one value was available, then that single value was used at Baseline.
Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate.
Observed data were used for analysis.
|
Baseline; Month 1
|
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
|
Change from Baseline is calculated as the post-Baseline value minus the Baseline value.
Baseline is defined as the average of the Screening Visit 4 and the Day 1 value.
If only 1 value is available, then that single value is used as Baseline.
Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate.
Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
|
Baseline; Month 1 and Month 2
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
|
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100.
Baseline apolipoprotein B (apoB) is defined as the Day 1 value.
Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values.
If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements.
Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate.
Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
|
Baseline; Month 1 and Month 2
|
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
|
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 Day 1 value.
Percent change from Baseline was analyzed using a non-parametric approach.
Missing Month 2 data were handled by LOCF.
Observed data were used for analysis at Month 1.
|
Baseline; Month 1 and Month 2
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Time Frame: up to Month 2 (until 30 days after last dose)
|
Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.
|
up to Month 2 (until 30 days after last dose)
|
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
Time Frame: Month 1 and Month 2
|
The number of participants with ALT or AST >3x ULN was measured.
|
Month 1 and Month 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Circulation. 2015 Dec 22;132(25):e396.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2017
Primary Completion (Actual)
January 29, 2018
Study Completion (Actual)
February 19, 2018
Study Registration Dates
First Submitted
June 19, 2017
First Submitted That Met QC Criteria
June 19, 2017
First Posted (Actual)
June 20, 2017
Study Record Updates
Last Update Posted (Actual)
April 3, 2020
Last Update Submitted That Met QC Criteria
March 20, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Evolocumab
- 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Other Study ID Numbers
- 1002-039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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