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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

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ClinicalTrials.gov Identifier: NCT03193047
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: bempedoic acid 180mg Other: placebo Drug: evolocumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arm Intervention/treatment
Experimental: bempedoic acid
Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
Drug: bempedoic acid 180mg
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
Other Name: ETC-1002

Drug: evolocumab
Monthly PCSK9i (evolocumab) background therapy
Other Name: Repatha

Placebo Comparator: placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
Other: placebo
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy

Drug: evolocumab
Monthly PCSK9i (evolocumab) background therapy
Other Name: Repatha




Primary Outcome Measures :
  1. Percent change of low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and 8 weeks ]
    Assess the 2-month efficacy of bempedoic acid 180 mg/day vs placebo in the reduction of LDL-C in patients on PCSK9i therapy


Secondary Outcome Measures :
  1. Percent change of low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and 4 weeks ]
    Assess the 1-month efficacy of bempedoic acid 180 mg/day vs placebo in the reduction of LDL-C in patients on PCSK9i therapy

  2. Percent change of apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), and high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
    Evaluate the effect of bempedoic acid 180 mg/day vs placebo on ApoB, non-HDL-C, TC, and hs-CRP after 1 and 2 months in patients on PCSK9i therapy

  3. Number of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Baseline through 8 weeks ]
    Evaluate the safety and tolerability of bempedoic acid 180 mg/day compared to placebo in patients on PCSK9i therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years or legal age of majority depending on regional law
  • Fasting, calculated LDL-C at screening ≥160 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193047


Locations
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United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
Sponsors and Collaborators
Esperion Therapeutics
Investigators
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Study Director: Narendra Lalwani, PhD Esperion Therapeutics

Additional Information:
Publications:
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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396.

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Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03193047     History of Changes
Other Study ID Numbers: 1002-039
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esperion Therapeutics:
Cholesterol
PCSK9
Repatha
evolocumab
LDL-C

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Hypoglycemic Agents