Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
NCT ID: NCT01941836
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
349 participants
INTERVENTIONAL
2013-09-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ETC-1002 120 mg/day
Orally, once daily in morning as capsules
ETC-1002
Patients receive ETC-1002
ETC-1002 180 mg/day
Orally, once daily in morning as capsules
ETC-1002
Patients receive ETC-1002
ezetimibe 10mg/day
Orally, once daily in morning as capsules
Ezetimibe
Patients receive ezetimibe
ETC-1002 120 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
ETC-1002
Patients receive ETC-1002
Ezetimibe
Patients receive ezetimibe
ETC-1002 180 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
ETC-1002
Patients receive ETC-1002
Ezetimibe
Patients receive ezetimibe
Interventions
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ETC-1002
Patients receive ETC-1002
Ezetimibe
Patients receive ezetimibe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Diane E MacDougall, MS
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Beverly Hills, California, United States
Chino, California, United States
Lincoln, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Thousand Oaks, California, United States
Vista, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Atlantis, Florida, United States
Brandon, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Oviedo, Florida, United States
Ponte Vedra, Florida, United States
Port Orange, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Meridian, Idaho, United States
Evansville, Indiana, United States
Kansas City, Kansas, United States
Auburn, Maine, United States
Lincoln, Nebraska, United States
Clifton, New Jersey, United States
Albuquerque, New Mexico, United States
New Windsor, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Mt. Pleasant, South Carolina, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Round Rock, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Olympia, Washington, United States
Renton, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1002-008
Identifier Type: -
Identifier Source: org_study_id
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