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AzTrials

HypercholesterolemiaPhase 2NCT03051100

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

A Phase 2 study testing Bempedoic acid 180mg, Ezetimibe 10mg and Atorvastatin 20mg in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
Bempedoic acid 180mg, Ezetimibe 10mg and Atorvastatin 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
11 sitesUnited States
Study dates
19 Jan 2017to 5 Jul 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • PMG Research of Cary

    Cary, North Carolina, 27518

  • PMG Research of Christie Clinic

    Champaign, Illinois, 61820

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • PMG Research of Hickory

    Hickory, North Carolina, 28601

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • PMG Research of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • PMG Research Salisbury

    Salisbury, North Carolina, 28144

  • Hampton Roads Center for Clinical Research

    Virginia Beach, Virginia, 23451

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C

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.

Being tested
Bempedoic acid 180mg, Ezetimibe 10mg, Atorvastatin 20mg, Placebo
Keywords
hyperlididemia, LDL, cholesterol
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bempedoic acid 180mgDrug

    Also called ETC-1002

    bempedoic acid 180 mg

  • Ezetimibe 10mgDrug

    Also called Zetia

    ezetimibe 10 mg

  • Atorvastatin 20mgDrug

    Also called Lipitor

    atorvastatin 20 mg

  • PlaceboOther

    placebo

Study groups in NCT03051100
Study groupRoleWhat they receive
Triplet TherapyExperimentalBempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
Receives: Drug: Bempedoic acid 180mg; Drug: Ezetimibe 10mg; Drug: Atorvastatin 20mg
placeboPlacebo comparatorMatching placebos taken orally, daily.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline; Week 6

Secondary outcomes (4)

  1. Percent Change From Baseline in Lipid Profile Parameters 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). 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.

    Measured: Baseline; Week 6

  2. Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at 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.

    Measured: Baseline; Week 6

  3. Number of Participants With LDL-C <70 mg/dL at 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.

    Measured: Week 6

  4. Number of Participants With LDL-C Reduction ≥50% From Baseline at 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.

    Measured: Baseline; Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start19 Jan 2017
  3. Primary completion1 Jun 2017
  4. Study completion5 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051100
Sponsor's protocol ID
1002-038
Status last verified
Mar 2020
First submitted
9 Feb 2017
Last updated
3 Apr 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27892461

  • 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.

    PubMed 27663902

  • 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.

    PubMed 27206943

  • 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.

    PubMed 27138185

  • 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.

    PubMed 26073387

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bempedoic acid 180mg, Ezetimibe 10mg and Atorvastatin 20mg in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 (time frame: Baseline; Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03051100, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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