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HypercholesterolemiaPhase 2NCT02072161

Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

A Phase 2 study testing ETC-1002 and Statin Therapy in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 40 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 research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
ETC-1002 and Statin Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
40 sitesUnited States
Study dates
Mar 2014to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
  • Fasting mean TG level ≤400 mg/dL
  • Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

Who cannot join

  • Clinically significant cardiovascular disease within 12 months of screening
  • Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
  • Type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
  • History of chronic musculoskeletal symptoms such as fibromyalgia
  • Uncontrolled hypothyroidism
Show all 15Show fewer
  • Liver disease or dysfunction
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal conditions or procedures or surgeries
  • Hematologic or coagulation disorders or low hemoglobin levels
  • HIV or AIDS
  • History of malignancy
  • History of drug or alcohol abuse within 2 years
  • Use of experimental or investigational drugs within 30 days of screening
  • Use of ETC-1002 in a previous clinical study

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Study site

    Boise, Idaho, 83704

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Brandon, Florida, 33511

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chino, California, 91710

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45245

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Denver, Colorado, 80220

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Los Angeles, California, 90057

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Lyndhurst, Ohio, 44124

  • Study site

    Marietta, Georgia, 30066

  • Study site

    Marion, Ohio, 43302

  • Study site

    Meridian, Idaho, 83646

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Muscle Shoals, Alabama, 35662

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Orem, Utah, 84058

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Ponte Vedra, Florida, 32081

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Sacramento, California, 95821

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Tampa, Florida, 33606

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Walnut Creek, California, 94595

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy

The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Read the detailed description

Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.

Being tested
ETC-1002, Placebo, Statin Therapy
Keywords
Statin, 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.

  • ETC-1002Drug

    ETC-1002 capsules, taken once daily oral

  • PlaceboDrug

    Placebo capsules, taken once daily oral

  • Statin TherapyDrug

    Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.

Study groups in NCT02072161
Study groupRoleWhat they receive
ETC-1002 120 mg/dayExperimentalOrally, once daily in morning as capsules
Receives: Drug: ETC-1002; Drug: Statin Therapy
ETC-1002 180 mg/dayExperimentalOrally, once daily in morning as capsules
Receives: Drug: ETC-1002; Drug: Statin Therapy
PlaceboPlacebo comparatorOrally, once daily in morning
Receives: Drug: Placebo; Drug: Statin Therapy

What is being measured

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

  1. Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)

    Measured: 12 weeks

Secondary outcomes (9)

  1. Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)

    Measured: 12 weeks

  2. Percent change in apolipoprotein B (ApoB)

    Measured: 12 weeks

  3. Percent change in total cholesterol (TC)

    Measured: 12 weeks

  4. Percent change in high-sensitivity C-reactive protein (hsCRP)

    Measured: 12 weeks

  5. Percent change in triglycerides (TG)

    Measured: 12 weeks

  6. Percent change in lipoprotein particle number

    Measured: 12 weeks

  7. Safety using adverse event reports; clinical laboratory results

    Measured: 12 weeks

  8. Safety using adverse event reports; vital signs

    Measured: 12 weeks

  9. Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228

    Measured: 12 weeks

Timeline

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

  1. First posted26 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072161
Sponsor's protocol ID
1002-009
Status last verified
Mar 2019
First submitted
24 Feb 2014
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.

    PubMed 24385236

  • Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.

    PubMed 23770179

  • Filippov S, Pinkosky SL, Lister RJ, Pawloski C, Hanselman JC, Cramer CT, Srivastava RAK, Hurley TR, Bradshaw CD, Spahr MA, Newton RS. ETC-1002 regulates immune response, leukocyte homing, and adipose tissue inflammation via LKB1-dependent activation of macrophage AMPK. J Lipid Res. 2013 Aug;54(8):2095-2108. doi: 10.1194/jlr.M035212. Epub 2013 May 24.

    PubMed 23709692

  • Pinkosky SL, Filippov S, Srivastava RA, Hanselman JC, Bradshaw CD, Hurley TR, Cramer CT, Spahr MA, Brant AF, Houghton JL, Baker C, Naples M, Adeli K, Newton RS. AMP-activated protein kinase and ATP-citrate lyase are two distinct molecular targets for ETC-1002, a novel small molecule regulator of lipid and carbohydrate metabolism. J Lipid Res. 2013 Jan;54(1):134-51. doi: 10.1194/jlr.M030528. Epub 2012 Nov 1.

    PubMed 23118444

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ETC-1002 and Statin Therapy in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 40 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 15 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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 calculated low density lipoprotein-cholesterol (LDL-C) (time frame: 12 weeks). 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 NCT02072161, which also lists 4 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 29 Mar 2019.

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