Trial · NCT01262638
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
NCT01262638, Phase 2, Completed, Esperion Therapeutics, Inc.; results first posted 2021-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides. Trials, record NCT01262638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01262638
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
- NCT number
- NCT01262638
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 177 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Dyslipidemia
- Interventions
- ETC-1002, Placebo
- First posted
- 2010-12-17
- Last updated
- 2021-03-17
- Results first posted
- 2021-03-16
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | 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). |
| Primary | Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | 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). |
| Secondary | Percent Change From Baseline to Week 12 in TG | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C) | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI) | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein (a) | 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 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). |
| Secondary | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA) | 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 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). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline; 12 weeks | Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study medication and had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessments taken more than 2 days after a dose of study medication | Percent Change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | Baseline; 12 weeks | mITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in TG | Baseline; 12 weeks | mITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline; 12 weeks | mITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-HDL-C | Baseline; 12 weeks | mITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; 12 weeks | mITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) | Baseline; 12 weeks | mITT Population. Only participants with available data were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI) | Baseline; 12 weeks | mITT Population. Only participants with available data were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Lipoprotein (a) | Baseline; 12 weeks | mITT Population. Only participants with available data were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA) | Baseline; 12 weeks | mITT Population. Only participants with available data were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | ETC-1002 40 mg | -17.9 | Standard Error 2.17 | Percent Change | |
| Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | ETC-1002 80 mg | -25.0 | Standard Error 2.12 | Percent Change | |
| Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | ETC-1002 120 mg | -26.6 | Standard Error 2.16 | Percent Change | |
| Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | Placebo | -2.1 | Standard Error 2.16 | Percent Change | |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | ETC-1002 40 mg | Normal (TG<150 mg/dL) | -17.8 | Standard Error 2.92 | Percent Change |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | ETC-1002 80 mg | Normal (TG<150 mg/dL) | -21.9 | Standard Error 2.73 | Percent Change |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | ETC-1002 120 mg | Normal (TG<150 mg/dL) | -29.2 | Standard Error 2.72 | Percent Change |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | Placebo | Normal (TG<150 mg/dL) | 0.3 | Standard Error 2.89 | Percent Change |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | ETC-1002 40 mg | Elevated (TG≥150 mg/dL) | -17.8 | Standard Error 3.21 | Percent Change |
| Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | ETC-1002 80 mg | Elevated (TG≥150 mg/dL) | -28.1 | Standard Error 3.22 | Percent Change |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ETC-1002 40 mg | 45 | |
| Overall Study | STARTED | ETC-1002 80 mg | 44 | |
| Overall Study | STARTED | ETC-1002 120 mg | 44 | |
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | COMPLETED | ETC-1002 40 mg | 38 | |
| Overall Study | COMPLETED | ETC-1002 80 mg | 38 | |
| Overall Study | COMPLETED | ETC-1002 120 mg | 38 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | ETC-1002 40 mg | 7 | |
| Overall Study | NOT COMPLETED | ETC-1002 80 mg | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | ETC-1002 40 mg | 3 | 45 | |
| other | Diarrhoea | Gastrointestinal disorders | ETC-1002 80 mg | 3 | 44 | |
| other | Diarrhoea | Gastrointestinal disorders | ETC-1002 120 mg | 1 | 44 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 44 | |
| other | Nausea | Gastrointestinal disorders | ETC-1002 40 mg | 3 | 45 | |
| other | Nausea | Gastrointestinal disorders | ETC-1002 80 mg | 3 | 44 | |
| other | Nausea | Gastrointestinal disorders | ETC-1002 120 mg | 4 | 44 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 44 | |
| other | Fatigue | General disorders | ETC-1002 40 mg | 3 | 45 | |
| other | Fatigue | General disorders | ETC-1002 80 mg | 1 | 44 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETC-1002 40 mg | 0 | 45 |
| Total, all-cause mortality | ETC-1002 80 mg | 0 | 44 |
| Total, all-cause mortality | ETC-1002 120 mg | 0 | 44 |
| Total, all-cause mortality | Placebo | 0 | 44 |
| Total, other adverse events | ETC-1002 40 mg | 15 | 45 |
| Total, other adverse events | ETC-1002 80 mg | 18 | 44 |
| Total, other adverse events | ETC-1002 120 mg | 17 | 44 |
| Total, other adverse events | Placebo | 17 | 44 |
| Total, serious adverse events | ETC-1002 40 mg | 0 | 45 |
| Total, serious adverse events | ETC-1002 80 mg | 0 | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23770179 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01262638/results?page=2