drugset / Trial / NCT02072161
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-01
- Completion
- 2015-01
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bempedoic acid | Small molecule | 120 mg | Oral |
| Subject | Bempedoic acid | Small molecule | 180 mg | Oral |
| Background | Atorvastatin | Small molecule | 10 mg | — |
| Background | Atorvastatin | Small molecule | 20 mg | — |
| Background | Pravastatin | Small molecule | 10 mg | — |
| Background | Pravastatin | Small molecule | 20 mg | — |
| Background | Pravastatin | Small molecule | 40 mg | — |
| Background | Rosuvastatin | Small molecule | 5 mg | — |
| Background | Rosuvastatin | Small molecule | 10 mg | — |
| Background | Simvastatin | Small molecule | 5 mg | — |
| Background | Simvastatin | Small molecule | 10 mg | — |
| Background | Simvastatin | Small molecule | 20 mg | — |