HypercholesterolemiaPhase 2NCT02178098
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
A Phase 2 study testing ETC-1002 in people with Hypercholesterolemia and Hypertension, run by Esperion Therapeutics, Inc. at 43 sites in United States.
Trial summary
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Hypertension
- What is being tested?
- ETC-1002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 43 sitesUnited States
- Study dates
- 16 Jun 2014to 22 May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
- or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
- Fasting LDL-C between 100 and 220 mg/dL
- Fasting triglycerides less than 400 mg/dL
- Body mass index (BMI) between 18 and 45 kg/m2
Who cannot join
- Known or suspected secondary hypertension or history of malignant hypertension
- Taking more than two anti-hypertension medications at the first visit
- History or current clinically significant cardiovascular disease
- History or current type 1 diabetes or type 2 diabetes
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Study site
Auburn, Maine, 04210
Study site
Berlin, New Jersey, 08009
Study site
Birmingham, Alabama, 35209
Study site
Butte, Montana, 59701
Study site
Chandler, Arizona, 85224
Study site
Chicago, Illinois, 60607
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45245
Study site
Cincinnati, Ohio, 45246
Study site
Corpus Christi, Texas, 78404
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75234
Study site
DeLand, Florida, 32720
Study site
Downingtown, Pennsylvania, 19335
Study site
Endwell, New York, 13760
Study site
Eugene, Oregon, 97404
Study site
Fort Lauderdale, Florida, 33306
Study site
Glendale, Arizona, 85306
Study site
Gurnee, Illinois, 60031
Study site
Hialeah, Florida, 33012
Study site
Houston, Texas, 77036
Study site
Indianapolis, Indiana, 46260
Study site
Kenosha, Wisconsin, 53142
Study site
Las Vegas, Nevada, 89123
Study site
Los Angeles, California, 90057
Study site
Lyndhurst, Ohio, 44124
Study site
Madison, Wisconsin, 53719
Study site
Meridian, Idaho, 83646
Site 1
Mt. Pleasant, South Carolina, 29464
Site 2
Mt. Pleasant, South Carolina, 29464
Study site
Muscle Shoals, Alabama, 35662
Study site
Olive Branch, Mississippi, 38654
Study site
Oviedo, Florida, 32765
Study site
Paducah, Kentucky, 42003
Study site
Pembroke Pines, Florida, 33026
Study site
Pembroke Pines, Florida, 33029
Study site
Port Orange, Florida, 32127
Study site
Salt Lake City, Utah, 84107
Study site
Salt Lake City, Utah, 84124
Study site
Simpsonville, South Carolina, 29681
Study site
Tulsa, Oklahoma, 74136
Study site
Willoughby Hills, Ohio, 44094
Study site
Wilmington, North Carolina, 28401
About this study
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.
- Conditions
- Hypercholesterolemia, Hypertension
- Being tested
- ETC-1002, Placebo
- Keywords
- LDL, Cholesterol
- Medical subject headings
- Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002Drug
ETC-1002 capsules taken once daily
PlaceboDrug
Placebo capsules taken once daily
| Study group | Role | What they receive |
|---|---|---|
| ETC-1002 | Experimental | ETC-1002 180 mg/day Receives: Drug: ETC-1002 |
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug
Measured: Baseline; 6 weeks
Secondary outcomes (17)
Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Mean Daytime SBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Mean Daytime DBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Mean Nighttime SBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Mean Nighttime DBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Sitting Cuff SBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline: 6 weeks
Change From Baseline in Sitting Cuff DBP to Week 6
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6
A non-parametric analysis was performed for hsCRP parameters. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. If hsCRP was <0.2, 0.1 was imputed for analysis. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in Total Cholesterol to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in Triglycerides (TG) to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value. Data was analyzed using non-parametric analysis.
Measured: Baseline; 6 weeks
Percent Change From Baseline in HDL-C to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value.
Measured: Baseline; 6 weeks
Change From Baseline in Body Weight to Week 6
Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; 6 weeks
Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228
Plasma trough concentration is defined as the lowest concentration reached before the next dose is administered.
Measured: Week 2, Week 4 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start16 Jun 2014
- Primary completion22 May 2015
- Study completion22 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Medpace Medical Monitor, Study director, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178098
- Sponsor's protocol ID
- 1002-014
- Status last verified
- Mar 2023
- First submitted
- 16 Jun 2014
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 23770179Gutierrez 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 24385236Pinkosky 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.
PubMed 23118444Filippov 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.
PubMed 23709692
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension
- ClinicalTrials.gov ID
- NCT02178098
- Acronym / sponsor ID
- 1002-014
- Conditions
- Hypercholesterolemia, Hypertension
- Keywords
- LDL, Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 22 May 2015 (actual)
- Study completion
- 22 May 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Posted 4 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.
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 | Experimental | Drug: ETC-1002ETC-1002 180 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
- or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
- Fasting LDL-C between 100 and 220 mg/dL
- Fasting triglycerides less than 400 mg/dL
- Body mass index (BMI) between 18 and 45 kg/m2
Key exclusion criteria (4 listed)
- Known or suspected secondary hypertension or history of malignant hypertension
- Taking more than two anti-hypertension medications at the first visit
- History or current clinically significant cardiovascular disease
- History or current type 1 diabetes or type 2 diabetes
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-1002ETC-1002 capsules taken once daily | Drug | ETC-1002 |
| PlaceboPlacebo capsules taken once daily | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6
Time frame: Baseline; 6 weeks
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug
17 secondary outcomes
Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Mean Daytime SBP to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Mean Daytime DBP to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Mean Nighttime SBP to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Mean Nighttime DBP to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Sitting Cuff SBP to Week 6
Time frame: Baseline: 6 weeks
Change From Baseline in Sitting Cuff DBP to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in Total Cholesterol to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in Triglycerides (TG) to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in HDL-C to Week 6
Time frame: Baseline; 6 weeks
Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6
Time frame: Baseline; 6 weeks
Change From Baseline in Body Weight to Week 6
Time frame: Baseline; 6 weeks
Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228
Time frame: Week 2, Week 4 and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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 23118444Pinkosky 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.
- Background: PubMed 23709692Filippov 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.
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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.
Medpace Medical Monitor study director
Medpace, Inc.
43 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 in people with Hypercholesterolemia and Hypertension, run by Esperion Therapeutics, Inc. at 43 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 5 inclusion and 4 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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6 (time frame: Baseline; 6 weeks). 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 NCT02178098, which also lists 4 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 4 Apr 2023.