Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 120 mg/day | Experimental | Orally, once daily in morning as capsules |
|
| ETC-1002 180 mg/day | Experimental | Orally, once daily in morning as capsules |
|
| Placebo | Placebo Comparator | Orally, once daily in morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | ETC-1002 capsules, taken once daily oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) | 12 weeks | |
| Percent change in apolipoprotein B (ApoB) | 12 weeks | |
| Percent change in total cholesterol (TC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diane E MacDougall | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muscle Shoals | Alabama | 35662 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24385236 | Background | 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. | |
| 23770179 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo capsules, taken once daily oral |
|
| Statin Therapy | Drug | 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. |
|
| 12 weeks |
| Percent change in high-sensitivity C-reactive protein (hsCRP) | 12 weeks |
| Percent change in triglycerides (TG) | 12 weeks |
| Percent change in lipoprotein particle number | 12 weeks |
| Safety using adverse event reports; clinical laboratory results | 12 weeks |
| Safety using adverse event reports; vital signs | 12 weeks |
| Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228 | 12 weeks |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Chino | California | 91710 | United States |
| Los Angeles | California | 90057 | United States |
| Sacramento | California | 95821 | United States |
| Walnut Creek | California | 94595 | United States |
| Denver | Colorado | 80220 | United States |
| Hartford | Connecticut | 06102 | United States |
| Brandon | Florida | 33511 | United States |
| Jacksonville | Florida | 32216 | United States |
| Oviedo | Florida | 32765 | United States |
| Ponte Vedra | Florida | 32081 | United States |
| Tampa | Florida | 33606 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Marietta | Georgia | 30066 | United States |
| Boise | Idaho | 83704 | United States |
| Meridian | Idaho | 83646 | United States |
| Evansville | Indiana | 47714 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Wichita | Kansas | 67205 | United States |
| Louisville | Kentucky | 40213 | United States |
| Port Gibson | Mississippi | 39150 | United States |
| Rochester | New York | 14609 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45245 | United States |
| Columbus | Ohio | 43213 | United States |
| Franklin | Ohio | 45005 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Marion | Ohio | 43302 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Greer | South Carolina | 29651 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Summerville | South Carolina | 29485 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Houston | Texas | 77030 | United States |
| Bountiful | Utah | 84010 | United States |
| Orem | Utah | 84058 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23294 | United States |
| Background |
| 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. |
| 23709692 | Background | 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. |
| 23118444 | Background | 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. |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
Not provided
Not provided
Not provided