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A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ETC-1002
Atorvastatin
Placebo
Sponsored by
Esperion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring LDL-cholesterol, Hypercholesterolemia, ETC-1002, Adenosine triphosphate citrate lyase, Atorvastatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ETC-1002 + Atorvastatin

Placebo + Atorvastatin

Arm Description

ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily

Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily

Outcomes

Primary Outcome Measures

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
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
Percent change in LDL-cholesterol
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C

Secondary Outcome Measures

Percent change in hsCRP
Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in total cholesterol
Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in non-HDL-cholesterol
Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in apolipoprotein B
Percent change from baseline to following 4 week treatment with ETC-1002
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

Full Information

First Posted
January 12, 2016
Last Updated
March 26, 2019
Sponsor
Esperion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02659397
Brief Title
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
LDL-cholesterol, Hypercholesterolemia, ETC-1002, Adenosine triphosphate citrate lyase, Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETC-1002 + Atorvastatin
Arm Type
Experimental
Arm Description
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Arm Title
Placebo + Atorvastatin
Arm Type
Placebo Comparator
Arm Description
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Intervention Type
Drug
Intervention Name(s)
ETC-1002
Other Intervention Name(s)
bempedoic acid
Intervention Description
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Primary Outcome Measure Information:
Title
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
Description
Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002
Time Frame
2 weeks
Title
24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites
Description
Fold change in AUC from prior-to to following 2 week treatment with ETC-1002
Time Frame
2 weeks
Title
Percent change in LDL-cholesterol
Description
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent change in hsCRP
Description
Percent change from baseline to following 4 week treatment with ETC-1002
Time Frame
4 weeks
Title
Percent change in total cholesterol
Description
Percent change from baseline to following 4 week treatment with ETC-1002
Time Frame
4 weeks
Title
Percent change in non-HDL-cholesterol
Description
Percent change from baseline to following 4 week treatment with ETC-1002
Time Frame
4 weeks
Title
Percent change in apolipoprotein B
Description
Percent change from baseline to following 4 week treatment with ETC-1002
Time Frame
4 weeks
Title
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite
Description
Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary McGowan, MD
Organizational Affiliation
Esperion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26073387
Citation
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.
Results Reference
background
PubMed Identifier
25463109
Citation
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.
Results Reference
background
PubMed Identifier
24978142
Citation
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.
Results Reference
background
PubMed Identifier
24385236
Citation
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.
Results Reference
background
PubMed Identifier
23770179
Citation
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.
Results Reference
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A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

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