A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients
1 other identifier
interventional
68
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2015
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMarch 29, 2019
March 1, 2019
7 months
January 12, 2016
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (5)
Percent change in hsCRP
4 weeks
Percent change in total cholesterol
4 weeks
Percent change in non-HDL-cholesterol
4 weeks
Percent change in apolipoprotein B
4 weeks
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite
2 weeks
Study Arms (2)
ETC-1002 + Atorvastatin
EXPERIMENTALETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Placebo + Atorvastatin
PLACEBO COMPARATORPlacebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Interventions
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Eligibility Criteria
You may qualify if:
- Taking daily stable statin doses for at least 4 weeks prior to screening visit.
- LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
- LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
- Must be willing to discontinue other lipid-regulating therapies during the study
You may not qualify if:
- History of acute significant cardiovascular disease.
- Current clinically significant cardiovascular disease.
- History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Northridge, California, 91324, United States
Unknown Facility
Clearwater, Florida, 33765, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Port Orange, Florida, 32127, United States
Unknown Facility
Boise, Idaho, 83642, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Springfield, Illinois, 62711, United States
Unknown Facility
Louisville, Kentucky, 40213, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Carrollton, Texas, 75006, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Arlington, Virginia, 22203, United States
Unknown Facility
Lynchburg, Virginia, 24501, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Renton, Washington, 98057, United States
Related Publications (5)
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.
PMID: 26073387BACKGROUNDNikolic 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.
PMID: 25463109BACKGROUNDFilippov 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.
PMID: 24978142BACKGROUNDGutierrez 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.
PMID: 24385236BACKGROUNDBallantyne 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.
PMID: 23770179BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mary McGowan, MD
Esperion Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 20, 2016
Study Start
December 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
March 29, 2019
Record last verified: 2019-03