DyslipidemiaPhase 2NCT01262638
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
A Phase 2 study testing ETC-1002 in people with Dyslipidemia, run by Esperion Therapeutics, Inc. at 11 sites in United States.
Trial summary
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- ETC-1002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2010to 23 Aug 2011
- 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
Major Inclusion Criteria:
- Provision of written informed consent prior to any study-specific procedure
- Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
- Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
- BMI between 18 and 35 mg/kg2
Major Exclusion Criteria:
- Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Chandler, Arizona, 85225
Study site
Chicago, Illinois, 60654
Study site
Greenbrae, California, 94904
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242
Study site
Jacksonville, Florida, 32216
Study site
Kalamazoo, Michigan, 49007
Study site
Louisville, Kentucky, 40213
Study site
Raleigh, North Carolina, 27609
Study site
Richmond, Virginia, 23294
Study site
Santa Rosa, California, 95405
About this study
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
- Conditions
- Dyslipidemia
- Being tested
- ETC-1002, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002Drug
ETC-1002 daily for 12 weeks
PlaceboDrug
Placebo daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ETC-1002 120 mg (Group 1) | Experimental | Subjects with hypercholesterolemia and normal triglycerides Receives: Drug: ETC-1002 |
| ETC-1002 80 mg (Group 2) | Experimental | Subjects with hypercholesterolemia and normal triglycerides Receives: Drug: ETC-1002 |
| ETC-1002 40 mg (Group 3) | Experimental | Subjects with hypercholesterolemia and normal triglycerides Receives: Drug: ETC-1002 |
| Placebo (Group 4) | Experimental | Subjects with hypercholesterolemia and normal triglycerides Receives: Drug: Placebo |
| ETC-1002 120 mg (Group 5) | Experimental | Subjects with hypercholesterolemia and elevated triglycerides Receives: Drug: ETC-1002 |
| ETC-1002 80 mg (Group 6) | Experimental | Subjects with hypercholesterolemia and elevated triglycerides Receives: Drug: ETC-1002 |
| ETC-1002 40 mg (Group 7) | Experimental | Subjects with hypercholesterolemia and elevated triglycerides Receives: Drug: ETC-1002 |
| Placebo (Group 8) | Experimental | Subjects with hypercholesterolemia and elevated triglycerides Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
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 Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum
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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Secondary outcomes (16)
Percent Change From Baseline to Week 12 in TG
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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TG values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)
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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Non-HDL-C
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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing non-HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TC values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
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 value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoB values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)
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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoAI values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Lipoprotein (a)
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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing Lipoprotein (a) values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)
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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing FFA values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)
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 value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing hsCRP values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total LDL Particles
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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total HDL Particles
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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Measured: Baseline; 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.
Measured: up to 12 weeks
Number of Participants With Clinically Significant Physical Examination Findings
Clinical significance was determined by the investigator.
Measured: up to 12 weeks
Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values
Clinical importance was determined by the investigator.
Measured: Baseline; up to 12 weeks
Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values
Clinical importance was determined by the investigator.
Measured: Baseline; up to 12 weeks
Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12
Laboratory abnormalities are laboratory values that are outside the normal range.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion23 Aug 2011
- Study completion23 Aug 2011
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 (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262638
- Sponsor's protocol ID
- ETC-1002-003
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2010
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 23770179
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.
- ClinicalTrials.gov ID
- NCT01262638
- Acronym / sponsor ID
- ETC-1002-003
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- 23 Aug 2011 (actual)
- Study completion
- 23 Aug 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 16 Mar 2021
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 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ETC-1002 120 mg (Group 1) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and normal triglycerides |
| ETC-1002 80 mg (Group 2) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and normal triglycerides |
| ETC-1002 40 mg (Group 3) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and normal triglycerides |
| Placebo (Group 4) | Experimental | Drug: PlaceboSubjects with hypercholesterolemia and normal triglycerides |
| ETC-1002 120 mg (Group 5) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and elevated triglycerides |
| ETC-1002 80 mg (Group 6) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and elevated triglycerides |
| ETC-1002 40 mg (Group 7) | Experimental | Drug: ETC-1002Subjects with hypercholesterolemia and elevated triglycerides |
| Placebo (Group 8) | Experimental | Drug: PlaceboSubjects with hypercholesterolemia and elevated triglycerides |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 daily for 12 weeks | Drug | ETC-1002 120 mg (Group 1), ETC-1002 120 mg (Group 5), ETC-1002 40 mg (Group 3), ETC-1002 40 mg (Group 7), ETC-1002 80 mg (Group 2), ETC-1002 80 mg (Group 6) |
| PlaceboPlacebo daily for 12 weeks | Drug | Placebo (Group 4), Placebo (Group 8) |
Primary outcome
Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline; 12 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 Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward).
Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum
Time frame: Baseline; 12 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
16 secondary outcomes
Percent Change From Baseline to Week 12 in TG
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Non-HDL-C
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Lipoprotein (a)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total LDL Particles
Time frame: Baseline; 12 weeks
Percent Change From Baseline to Week 12 in Total HDL Particles
Time frame: Baseline; 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 12 weeks
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: up to 12 weeks
Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values
Time frame: Baseline; up to 12 weeks
Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values
Time frame: Baseline; up to 12 weeks
Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 Dyslipidemia, run by Esperion Therapeutics, Inc. at 11 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?
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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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 16 Mar 2021). 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 to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) (time frame: Baseline; 12 weeks). The study lists 2 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 NCT01262638, which also lists 1 linked publication.
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 17 Mar 2021.