HyperlipidemiaPhase 2NCT02659397
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
A Phase 2 study testing ETC-1002 and Atorvastatin in people with Hyperlipidemia, run by Esperion Therapeutics, Inc. at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- ETC-1002 and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2015to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Anaheim, California, 92801
Study site
Arlington, Virginia, 22203
Study site
Berlin, New Jersey, 08009
Study site
Boise, Idaho, 83642
Study site
Carrollton, Texas, 75006
Study site
Chicago, Illinois, 60607
Study site
Clearwater, Florida, 33765
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90057
Study site
Louisville, Kentucky, 40213
Study site
Lynchburg, Virginia, 24501
Study site
Miami, Florida, 33126
Study site
Northridge, California, 91324
Study site
Port Orange, Florida, 32127
Study site
Rapid City, South Dakota, 57701
Study site
Renton, Washington, 98057
Study site
Richmond, Virginia, 23294
Study site
Springfield, Illinois, 62711
Study site
West Jordan, Utah, 84088
About this study
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
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.
- Conditions
- Hyperlipidemia
- Being tested
- ETC-1002, Atorvastatin, Placebo
- Keywords
- LDL-cholesterol, Hypercholesterolemia, ETC-1002, Adenosine triphosphate citrate lyase, Atorvastatin
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002Drug
Also called bempedoic acid
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
AtorvastatinDrug
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
PlaceboDrug
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
| Study group | Role | What they receive |
|---|---|---|
| ETC-1002 + Atorvastatin | Experimental | ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily Receives: Drug: ETC-1002; Drug: Atorvastatin |
| Placebo + Atorvastatin | Placebo comparator | Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily Receives: Drug: Atorvastatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 weeks
Percent change in LDL-cholesterol
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
Measured: 4 weeks
Secondary outcomes (5)
Percent change in hsCRP
Percent change from baseline to following 4 week treatment with ETC-1002
Measured: 4 weeks
Percent change in total cholesterol
Percent change from baseline to following 4 week treatment with ETC-1002
Measured: 4 weeks
Percent change in non-HDL-cholesterol
Percent change from baseline to following 4 week treatment with ETC-1002
Measured: 4 weeks
Percent change in apolipoprotein B
Percent change from baseline to following 4 week treatment with ETC-1002
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary McGowan, MD, Study director, Esperion Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659397
- Sponsor's protocol ID
- 1002-035
- Status last verified
- Mar 2019
- First submitted
- 12 Jan 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26073387Nikolic 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.
PubMed 25463109Filippov 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.
PubMed 24978142Gutierrez 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.
PubMed 24385236Ballantyne 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.
PubMed 23770179
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02659397
- Acronym / sponsor ID
- 1002-035
- Conditions
- Hyperlipidemia
- Keywords
- LDL-cholesterol, Hypercholesterolemia, ETC-1002, Adenosine triphosphate citrate lyase, Atorvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETC-1002 + Atorvastatin | Experimental | Drug: ETC-1002, Drug: AtorvastatinETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily |
| Placebo + Atorvastatin | Placebo comparator | Drug: Atorvastatin, Drug: PlaceboPlacebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETC-1002Also: bempedoic acidBlinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4) | Drug | ETC-1002 + Atorvastatin |
| AtorvastatinAtorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4) | Drug | ETC-1002 + Atorvastatin, Placebo + Atorvastatin |
| PlaceboBlinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4) | Drug | Placebo + Atorvastatin |
Primary outcome
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
Time frame: 2 weeks
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
Time frame: 2 weeks
Fold change in AUC from prior-to to following 2 week treatment with ETC-1002
Percent change in LDL-cholesterol
Time frame: 4 weeks
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
5 secondary outcomes
Percent change in hsCRP
Time frame: 4 weeks
Percent change in total cholesterol
Time frame: 4 weeks
Percent change in non-HDL-cholesterol
Time frame: 4 weeks
Percent change in apolipoprotein B
Time frame: 4 weeks
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 26073387Thompson 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.
- Background: PubMed 25463109Nikolic 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.
- Background: PubMed 24978142Filippov 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.
- Background: PubMed 24385236Gutierrez 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: PubMed 23770179Ballantyne 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary McGowan, MD study director
Esperion Therapeutics, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ETC-1002 and Atorvastatin in people with Hyperlipidemia, run by Esperion Therapeutics, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659397, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.