NCT03051100

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

11 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

January 19, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

February 9, 2017

Results QC Date

March 20, 2020

Last Update Submit

March 20, 2020

Conditions

Hypercholesterolemia

Keywords

hyperlididemiaLDLcholesterol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Percent Change From Baseline in Lipid Profile Parameters at Week 6

    Baseline; Week 6

  • Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6

    Baseline; Week 6

  • Number of Participants With LDL-C <70 mg/dL at Week 6

    Week 6

  • Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6

    Baseline; Week 6

Study Arms (2)

Triplet Therapy

EXPERIMENTAL

Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.

Drug: Bempedoic acid 180mgDrug: Ezetimibe 10mgDrug: Atorvastatin 20mg

placebo

PLACEBO COMPARATOR

Matching placebos taken orally, daily.

Other: Placebo

Interventions

Bempedoic acid 180mgDRUG

bempedoic acid 180 mg

Also known as: ETC-1002
Triplet Therapy
Ezetimibe 10mgDRUG

ezetimibe 10 mg

Also known as: Zetia
Triplet Therapy
Atorvastatin 20mgDRUG

atorvastatin 20 mg

Also known as: Lipitor
Triplet Therapy
PlaceboOTHER

placebo

placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

PMG Research of Christie Clinic

Champaign, Illinois, 61820, United States

Location

PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

Sensenbrenner Primary Care

Charlotte, North Carolina, 28277, United States

Location

PMG Research of Hickory

Hickory, North Carolina, 28601, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

PMG Research Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Hampton Roads Center for Clinical Research

Virginia Beach, Virginia, 23451, 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

  • Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. doi: 10.1007/s11883-016-0611-4.

    PMID: 27663902BACKGROUND

  • 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.

    PMID: 27206943BACKGROUND

  • 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.

    PMID: 27138185BACKGROUND

  • 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.

    PMID: 26073387BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidEzetimibeAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

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

Study Officials

  • Ron Haberman, MD

    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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

January 19, 2017

Primary Completion

June 1, 2017

Study Completion

July 5, 2017

Last Updated

April 3, 2020

Results First Posted

April 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(11)