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The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 + Atorvastatin | Experimental | ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily |
|
| Placebo + Atorvastatin | Placebo Comparator | Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites | Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002 | 2 weeks |
| 24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites | Fold change in AUC from prior-to to following 2 week treatment with ETC-1002 | 2 weeks |
| Percent change in LDL-cholesterol | Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in hsCRP | Percent change from baseline to following 4 week treatment with ETC-1002 | 4 weeks |
| Percent change in total cholesterol | Percent change from baseline to following 4 week treatment with ETC-1002 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary McGowan, MD | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26073387 | Background | 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. | |
| 25463109 | Background | Nikolic D, Mikhailidis DP, Davidson MH, Rizzo M, Banach M. ETC-1002: a future option for lipid disorders? Atherosclerosis. 2014 Dec;237(2):705-10. doi: 10.1016/j.atherosclerosis.2014.10.099. Epub 2014 Oct 31. |
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| Atorvastatin | Drug | Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4) |
|
| Placebo | Drug | Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4) |
|
| 4 weeks |
| Percent change in non-HDL-cholesterol | Percent change from baseline to following 4 week treatment with ETC-1002 | 4 weeks |
| Percent change in apolipoprotein B | Percent change from baseline to following 4 week treatment with ETC-1002 | 4 weeks |
| 24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite | Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002 | 2 weeks |
| Los Angeles |
| California |
| 90057 |
| United States |
| Northridge | California | 91324 | United States |
| Clearwater | Florida | 33765 | United States |
| Jacksonville | Florida | 32216 | United States |
| Miami | Florida | 33126 | United States |
| Port Orange | Florida | 32127 | United States |
| Boise | Idaho | 83642 | United States |
| Chicago | Illinois | 60607 | United States |
| Springfield | Illinois | 62711 | United States |
| Louisville | Kentucky | 40213 | United States |
| Berlin | New Jersey | 08009 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Carrollton | Texas | 75006 | United States |
| West Jordan | Utah | 84088 | United States |
| Arlington | Virginia | 22203 | United States |
| Lynchburg | Virginia | 24501 | United States |
| Richmond | Virginia | 23294 | United States |
| Renton | Washington | 98057 | United States |
| 24978142 | Background | Filippov S, Pinkosky SL, Newton RS. LDL-cholesterol reduction in patients with hypercholesterolemia by modulation of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase. Curr Opin Lipidol. 2014 Aug;25(4):309-15. doi: 10.1097/MOL.0000000000000091. |
| 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 | 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. |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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