NCT03067441

Brief Summary

The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,462

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2017

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

February 24, 2017

Results QC Date

November 4, 2020

Last Update Submit

February 3, 2021

Conditions

HypercholesterolemiaAtherosclerotic Cardiovascular Disease

Keywords

hyperlipidemiacholesterolheterozygous familial hypercholesterolemiaatherosclerotic cardiovascular diseaseASCVDHeFHLDL

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study.

    Up to Week 82

Secondary Outcomes (16)

  • Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78

    Baseline; Week 52 and Week 78

  • Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78

    Baseline; Week 52 and Week 78

  • Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78

    Baseline; Week 52 and Week 72

  • Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78

    Baseline; Week 52 and Week 78

  • Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78

    Baseline; Week 52 and Week 78

  • +11 more secondary outcomes

Study Arms (1)

Open-Label bempedoic acid

EXPERIMENTAL

bempedoic acid 180 mg tablet

Drug: bempedoic acid

Interventions

bempedoic acidDRUG

bempedoic acid 180 mg tablets taken orally, once per day.

Also known as: ETC-1002
Open-Label bempedoic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successfully completed CLEAR Harmony (1002-040) parent study

You may not qualify if:

  • Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
  • Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jedidiah Clinical Research

Tampa, Florida, 33607, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Sentral Clinical Research Services

Cincinnati, Ohio, 45236, United States

Location

Related Publications (5)

  • 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.

    PMID: 27892461BACKGROUND

  • 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.

    PMID: 24222016BACKGROUND

  • Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12.

    PMID: 21600525BACKGROUND

  • Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363.

    PMID: 18537526BACKGROUND

  • 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.

    PMID: 11535564BACKGROUND

Related Links

MeSH Terms

Conditions

HypercholesterolemiaAtherosclerosisHyperlipidemias

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Medical Director
Organization
Esperion Therapeutics, Inc.
medinfo@esperion.com
1-833-377-7633

Study Officials

  • Medical Director

    Esperion Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 1, 2017

Study Start

February 3, 2017

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

March 1, 2021

Results First Posted

December 22, 2020

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)