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HypercholesterolemiaPhase 2NCT01941836

Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

A Phase 2 study testing ETC-1002 and Ezetimibe in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 68 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, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol… 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 Ezetimibe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
68 sitesUnited States
Study dates
Sep 2013to Nov 2014
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

  • Statin intolerant and statin tolerant
  • Fasting LDL-C between 130 mg/dL and 220 mg/dL
  • Fasting triglyceride less than or equal to 400 mg/dL
  • Body mass index (BMI) between 18 and 45 kg/m2

Who cannot join

  • History or current clinically significant cardiovascular disease
  • History or current type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 3 months of screening
  • History of joint symptoms difficult to differentiate from myalgia
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
Show all 13Show fewer
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal (GI) conditions or prior GI procedures
  • HIV or AIDS
  • History or malignancy
  • History or drug or alcohol abuse within last 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

68 sites in 1 country.

68 sites in 1 country

United States68 sites

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Auburn, Maine, 04210

  • Study site

    Austin, Texas, 78731

  • Study site

    Beachwood, Ohio, 26900

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Brandon, Florida, 33511

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chino, California, 91710

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45227

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75230

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80220

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77072

  • Study site

    Houston, Texas, 77074

  • Study site

    Jacksonville, Florida, 32223

  • Study site

    Kansas City, Kansas, 66214

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Lincoln, California, 95821

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90059

  • 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

    New Windsor, New York, 12553

  • Study site

    Newport Beach, California, 92663

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Olympia, Washington, 98502

  • Study site

    Orem, Utah, 84058

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Ponte Vedra, Florida, 32081

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Renton, Washington, 98057

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Round Rock, Texas, 78681

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    Seattle, Washington, 98104

  • Study site

    Spokane, Washington, 99204

  • Study site

    St. Petersburg, Florida, 33756

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Vista, California, 92083

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Williamsville, New York, 14221

  • Study site

    Willoughby Hills, Ohio, 44094

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Read the detailed description

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Being tested
ETC-1002, Ezetimibe
Keywords
Statin intolerant, Statin tolerant, 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

    Patients receive ETC-1002

  • EzetimibeDrug

    Also called Zetia

    Patients receive ezetimibe

Study groups in NCT01941836
Study groupRoleWhat they receive
ETC-1002 120 mg/dayExperimentalOrally, once daily in morning as capsules
Receives: Drug: ETC-1002
ETC-1002 180 mg/dayExperimentalOrally, once daily in morning as capsules
Receives: Drug: ETC-1002
ezetimibe 10mg/dayActive comparatorOrally, once daily in morning as capsules
Receives: Drug: Ezetimibe
ETC-1002 120 mg/day + ezetimibe 10mg/dayExperimentalOrally, once daily in morning
Receives: Drug: ETC-1002; Drug: Ezetimibe
ETC-1002 180 mg/day + ezetimibe 10mg/dayExperimentalOrally, once daily in morning
Receives: Drug: ETC-1002; Drug: Ezetimibe

What is being measured

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

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

    Measured: Baseline and 12 weeks

Secondary outcomes (6)

  1. Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)

    Measured: Baseline and 12 weeks

  2. Safety using adverse event reports; vital signs

    Measured: up to 21 weeks including screening

  3. Percent change in Apolipoprotein B (ApoB)

    Measured: Baseline and 12 weeks

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

    Measured: Baseline and 12 weeks

  5. Safety using adverse event reports; clinical laboratory results

    Measured: up to 21 weeks including screening

  6. Safety using adverse event reports; rates of muscle-related adverse

    Measured: up to 21 weeks including screening

Timeline

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

  1. First posted13 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2014
  4. Study completionNov 2014

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
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01941836
Sponsor's protocol ID
1002-008
Status last verified
Mar 2019
First submitted
6 Sep 2013
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ETC-1002 and Ezetimibe in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 68 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 4 inclusion and 13 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 68 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. 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 in calculated low density lipoprotein-cholesterol (LDL-C) (time frame: Baseline and 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 NCT01941836, 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 29 Mar 2019.

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