This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Trilipix Effects on Lipids and Arteries (NCT01025492), a randomized phase 4 study. The primary outcome is Apolipoprotein A-I Serum Concentration.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01025492 |
| Phase | Phase 4 |
| Condition | Dyslipidemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Utah |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned subjects with insulin resistance, described in its official title as having hypertriglyceridemia and low HDL-C. Dyslipidemia is the listed condition. The registry does not report further eligibility details in the available record.
Intervention
Trilipix, identified as fenofibric acid, was described as a 135 mg tablet taken orally once daily for 12 weeks, added to ongoing statin treatment.
Comparator
The comparator was a matching placebo tablet taken orally once daily for 12 weeks, also alongside ongoing statin treatment. The registry does not report which participants received each treatment because unblinding information was not provided to the investigator or study team.
Primary question
The registered primary outcome was serum apolipoprotein A-I concentration. The stated comparison was the concentration after 12 weeks of treatment with Trilipix or placebo. Numerical results for this comparison are not reported in the registry record.
In practical terms, the planned question was whether adding fenofibric acid to statin treatment was associated with a different apolipoprotein A-I concentration at the registered assessment time than adding placebo. The study description also identifies HDL composition and arterial function as areas of interest. Those broader aims do not replace the registered primary endpoint, and the registry does not provide a reported result for it.
The record lists enrollment of 24 participants and states that the study was terminated prematurely. It also explains that treatment assignments were not disclosed to the investigator or study team and that the endpoint text is incomplete. Consequently, the posted information does not establish how many participants were assigned to either treatment, what values were measured, or what comparison was obtained.
3. Trial Design
The registry describes a Phase 4, randomized, quadruple-masked, parallel-group study. Random allocation indicates that assignment was intended to occur by chance; quadruple masking indicates that the record describes masking across four roles, but the available entry does not identify those roles or detail how masking was implemented. A parallel design means participants were assigned to a treatment group rather than described as crossing between treatments.
The two listed interventions were Trilipix and placebo. The Trilipix regimen was a 135 mg oral tablet once daily for 12 weeks; the placebo was a matching tablet taken orally once daily for 12 weeks. Both were described in the context of ongoing statin treatment. The registry does not state the statin regimen or provide further details about treatment adherence or concomitant care.
The recorded enrollment was 24. The study start is listed as 2009-11 and the primary completion as 2011-03. Its current status is recorded as terminated. The record states that the clinical trial collaborator or corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team. It does not report the reason for termination.
The planned primary endpoint was a comparison of serum apolipoprotein A-I concentrations after 12 weeks. The record lists one outcome measure, but no analysis is listed. It does not report a completed treatment-group comparison, participant disposition by arm, or an analysis population. The missing unblinding information is particularly consequential: the record says that it is not known to which group each enrolled participant belonged.
These design details describe the registered plan and the information posted about the trial; they do not establish that every planned procedure was completed. The registry does not report the allocation sequence method, concealment procedures, masking checks, or actual treatment exposure. Those details should not be inferred from the labels randomized, quadruple-masked, and parallel.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled.
Overall Study
| Stage | Trilipix or Placebo |
|---|---|
| STARTED | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team. It is not known to which arm/group each of the participants enrolled, therefore all enrolled subjects were included in a single arm/group.
| Characteristic | Unit | Trilipix or Placebo |
|---|---|---|
| Participants analysed | 24 | |
| Age, Continuous | years | 59.5 (SD 10.3) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Apolipoprotein A-I Serum Concentration, measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The registered primary endpoint was serum apolipoprotein A-I concentration, with an assessment timeframe of 12 weeks. Apolipoprotein A-I is a protein associated with HDL particles. As general background, measuring its concentration can help characterize HDL-related biology; a concentration is not itself a direct measurement of arterial function or a clinical cardiovascular outcome.
The registry describes the endpoint as a comparison of apolipoprotein A-I concentrations after treatment with Trilipix or placebo. The study summary additionally identifies HDL composition and arterial function as areas of interest. The endpoint description is incomplete in the posted record, and no numerical concentration, group summary, treatment effect, measure of variability, or statistical test result is reported.
That absence limits interpretation. Without values by treatment group and a stated comparison estimate, the direction and size of any difference cannot be determined. Without information about variability or uncertainty, precision cannot be assessed either. The registry record also says participants’ treatment assignments were not known to the investigator or study team. As a result, the posted endpoint information does not support a treatment-specific interpretation of apolipoprotein A-I concentrations.
In general, a biomarker endpoint can describe a biological measure at a specified assessment time, but it does not by itself establish a difference in clinical outcomes. For this study, even the biomarker comparison is not numerically reported, so no conclusion about its observed magnitude or precision can be drawn from the registry entry.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of Trilipix and placebo added to ongoing statin treatment, with serum apolipoprotein A-I concentration at 12 weeks as the primary endpoint. It also records enrollment of 24 and premature termination. Those details characterize the study plan and its status; they do not provide an estimate of the treatment contrast.
No numerical primary-outcome results are reported in the registry record. There are no reported group concentrations, difference estimate, confidence interval, standard error, dispersion measure, or p-value. The number of analyses is listed as zero. Accordingly, neither the direction nor magnitude of a difference between treatment groups can be described, and the precision of such a difference cannot be evaluated. It would be inappropriate to infer a null result from the lack of a reported analysis.
The registry gives a specific reason that treatment-specific interpretation is unavailable: the collaborator or corporate sponsor terminated the study prematurely and did not provide unblinding information to the investigator or study team. The record says that the treatment group for each enrolled participant is therefore unknown. Even if outcome values existed outside the posted entry, the information recorded does not permit those values to be assigned to the randomized groups.
General statistical interpretation distinguishes absence of evidence from evidence of no difference. A reported estimate near zero with adequate precision could be informative about the range of effects compatible with the data. By contrast, an absent estimate supplies no such range. In this record, there is no confidence interval to assess and no test result to interpret. No claim about statistical significance or equivalence follows from the absence of results.
The enrollment figure alone cannot resolve this uncertainty. Sample size describes how many participants were enrolled, not how much information was available for the primary comparison. The registry does not provide enrollment by group, the number with an endpoint measurement, the amount of missing outcome data, or the analysis population. Those omissions prevent assessment of the effective information supporting the intended comparison.
The study summary frames its scientific interest around HDL composition and arterial function in subjects with insulin resistance receiving statin treatment. The registry’s primary outcome, however, is apolipoprotein A-I concentration. No results for arterial function or other HDL measures are reported in the available entry. The background statement about fibrates in the summary is rationale, not a result from this trial.
Overall, the posted record supports a description of the intended comparison and the barriers to interpreting it, but not an estimate of what the comparison found. The primary endpoint’s numerical results are not reported in the registry record. The missing treatment assignments and absence of analyses mean that the record cannot establish an observed treatment effect, its uncertainty, or whether any difference was compatible with a range of values.
9. Statistical Methods Explained
The registry describes the trial as randomized, quadruple-masked, and parallel-group. These terms concern how a study is organized; they do not substitute for a reported statistical analysis. The record does not describe the randomization procedure, how allocation was concealed, which roles were masked, or how masking was maintained. It also does not report an analysis plan that would explain how the primary endpoint was to be compared.
What a treatment comparison would estimate
In general, a treatment comparison for a continuous endpoint such as serum concentration estimates how the outcome differs between groups under a specified analysis. A group mean difference is one familiar form of summary, but the registry does not report a group mean or any other treatment-effect estimate for apolipoprotein A-I. No particular estimator should therefore be attributed to this study. The registered endpoint establishes the measure and assessment time, not the calculation used to analyze it.
A confidence interval, in general, represents uncertainty around an estimated effect under the assumptions of the analysis. Its width conveys precision: a narrower interval indicates greater precision than a wider interval, all else being comparable. Here, no interval or estimate is reported. It is therefore not possible to judge whether the intended comparison would have been precise or to identify which effect sizes might be consistent with the observed data.
A p-value, in general, describes how incompatible data are with a specified null hypothesis under a statistical model. It does not measure the probability that a treatment works, and it does not describe the size of an effect. No p-value is reported for the primary endpoint. Since there is also no estimate or uncertainty interval, significance testing cannot be interpreted from the registry entry.
Why allocation information matters
Random allocation is intended to make treatment groups comparable on average with respect to factors measured and unmeasured at baseline. That property helps support a causal comparison when allocation is preserved and outcomes are analyzed appropriately. It does not guarantee balance in a small realized sample, and it does not eliminate the need to document who was assigned to each group and who contributed outcome data.
In this trial, the record specifically states that the study team was not given unblinding information and could not know which group each participant belonged to. That prevents the posted record from linking participant outcomes to Trilipix or placebo. Without that link, the primary group comparison cannot be reconstructed from the registry information. The record does not report an alternative blinded or coded analysis.
Missingness, variability, and analysis choices
General analysis of a continuous endpoint requires information about the observed values and their variability, as well as a clear account of missing measurements. Variability matters because participants may have different measured concentrations even within the same treatment group; it affects the uncertainty of a group contrast. The registry does not report outcome values, standard deviations or other dispersion measures, the number of participants measured at the endpoint, or missing-data handling.
Different missing-data assumptions can lead to different interpretations. For example, an analysis limited to participants with measurements answers a different question from an analysis that uses a justified method to account for missing values. This is general statistical context, not a description of the trial’s method: the registry does not report which approach, if any, was used. It also does not report whether an intention-to-treat population, a per-protocol population, or another analysis population was specified.
Multiplicity and model assumptions
When investigators test or estimate multiple outcomes or contrasts, multiplicity can increase the chance of a misleading finding if results are interpreted without regard to how many comparisons were considered. The registry lists one outcome measure, but it does not report a multiplicity strategy, a hierarchy of endpoints, or the number of analyses actually planned. The listed count of analyses is zero. The available record therefore does not support claims about adjustment or a prespecified testing sequence.
Statistical models also rely on assumptions. For continuous outcomes, an analysis might make assumptions about the distribution of measurements or the relationship between variability and treatment. Those assumptions need to be evaluated in light of the actual data and chosen analysis. The registry does not identify a model, diagnostic checks, covariate adjustments, or sensitivity analyses. No model-based result can be reconstructed from the posted information.
In general, over-dispersion describes variability greater than a model expects. It can make standard errors too small if the model fails to accommodate that extra variation. This concept does not imply that over-dispersion occurred in this study; the outcome data and analysis model needed to assess it are not reported.
The registry’s sample-size assumptions describe a planning illustration based on an observed effect and specified hypothetical design choices, but the record indicates that the primary outcome has fewer than two arms for that calculation. Those assumptions are not a trial-specific design justification or an observed-power result. The registry does not report a sample-size justification for the study, and no conclusion about power can be drawn from enrollment alone.
For this study, the central methodological limitation is not a choice between competing reported analyses: no primary analysis is listed, numerical endpoint results are absent, and participant treatment assignments were unavailable to the study team. General statistical tools such as effect estimates, confidence intervals, and model diagnostics require data and analysis details that the record does not contain.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, identified as serum apolipoprotein A-I concentration at 12 weeks. It lists no analyses. No multiplicity adjustment, prespecified testing hierarchy, or plan for handling multiple comparisons is reported in the registry record. The record’s listing of one outcome measure does not establish whether additional outcomes or analyses were considered outside the posted entry.
Missing-data methods are not reported. The registry does not state how many participants had a primary endpoint measurement, whether any measurements were missing, why they might have been missing, or how missing values were handled. It also does not describe imputation, sensitivity analyses, or assumptions about missingness. Consequently, the impact of missing endpoint data cannot be assessed.
Analysis-population definitions are also not reported. The entry does not identify an intention-to-treat, per-protocol, safety, or other efficacy population for the primary comparison. Although enrollment is recorded as 24, the number assigned to each arm and the number included in any endpoint analysis are not stated. Enrollment should not be mistaken for the number analyzed.
The record adds a further limitation: the study was terminated prematurely, and the investigator or study team did not receive unblinding information. It says that participant assignments to treatment groups are unknown. This means the posted entry cannot establish which observations belong to the Trilipix group and which belong to placebo. Taken together with the absence of a listed analysis and endpoint results, these omissions leave the intended treatment comparison uninterpretable statistically.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Trilipix or Placebo | 0 | 24 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Trilipix or Placebo | 0 of 24 |
The registry’s adverse-event entry combines participants under the label “Trilipix or Placebo.” It records 24 participants at risk for serious adverse events and zero affected by a serious adverse event. For other adverse events, it likewise records 24 at risk and zero affected. These figures are reported for the combined group label, not separately for Trilipix and placebo.
Because treatment assignments were not disclosed to the investigator or study team, the posted safety figures cannot be attributed to one treatment arm or used to compare event counts between arms. The figures describe what the registry lists for the combined group, not a treatment-specific risk estimate. They do not provide information about the timing, duration, or individual details of events.
The death field is not populated with a count; a death count is not reported in the registry record. This should not be read as a reported count of zero. The safety entry also does not report statistical comparisons, uncertainty intervals, or a detailed adverse-event listing. Accordingly, these figures have a narrow interpretation: the registry records zero affected among the combined 24 at risk for both serious and other adverse events, while leaving treatment-specific safety interpretation unavailable.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase 4 randomized, quadruple-masked, parallel-group study was intended to compare Trilipix with matching placebo, both alongside ongoing statin treatment. It records an enrollment of 24, a primary endpoint of serum apolipoprotein A-I concentration at 12 weeks, and a terminated study status. It also states that the treatment assignments were not known to the investigator or study team.
It does not establish what the primary endpoint comparison found. No group values, effect estimate, uncertainty interval, or p-value are reported in the registry record. There is no numerical result from which to describe the direction, size, or precision of a difference. The absence of a reported analysis is not evidence that the treatments produced the same result, nor does it demonstrate that one differed from the other.
The record also does not establish that the study’s broader scientific interests in HDL composition and arterial function produced any particular result. Those interests appear in the study summary, but the posted entry does not report numerical findings for them. Background statements about fibrates in the summary describe the rationale for investigation and should not be treated as findings from this trial.
General statistical interpretation separates a biomarker result from a clinical outcome. Even if a biomarker comparison were available, it would describe that measure under the study’s analysis; it would not alone answer every question about clinical benefit or harm. Here, the biomarker comparison itself is not reported, so even that narrower interpretation is unavailable.
The registry’s safety counts are also limited. They are combined across the “Trilipix or Placebo” group label and cannot be assigned to either treatment arm. They therefore do not establish a comparative safety result. The missing death count should not be interpreted as zero.
The most defensible conclusion is about the record rather than the treatments: the intended comparison is identifiable, but its outcome cannot be interpreted from the posted results. The record does not establish efficacy, lack of efficacy, equivalence, or a treatment-specific safety difference.
13. Why This Trial Matters Statistically
This trial is statistically notable because its design labels suggest an interpretable randomized comparison, while the posted record lacks the information needed to recover that comparison. Randomization can support a fair estimate when participants’ assigned groups and outcome data are available for analysis. Here, the record explicitly states that group assignments were not disclosed to the investigator or study team, and it lists no analyses.
The distinction between a study’s planned question and its reported evidence is important. The primary question is clear: compare apolipoprotein A-I concentrations after 12 weeks of Trilipix or placebo alongside ongoing statin treatment. But a clearly defined question does not produce an estimate on its own. Without group results, uncertainty measures, and analysis details, readers cannot evaluate the magnitude or precision of the comparison.
The enrollment figure of 24 also illustrates why sample size alone is not an inferential result. Enrollment does not reveal the number with endpoint data, the distribution of participants across treatment groups, or the variability of the outcome. It cannot substitute for a treatment-effect estimate or a confidence interval. The registry does not provide the additional information needed to assess those features.
Termination and unavailable unblinding information have direct implications for statistical interpretation. The status explains that the study ended prematurely, while the endpoint and treatment-group information needed to interpret the intended comparison are absent. This is not the same as a reported negative result; it is a record in which the primary comparison cannot be evaluated from the posted information.
For clinical researchers, the case underscores the value of transparent reporting of participant flow, treatment assignments, endpoint data, analysis populations, statistical methods, and uncertainty. Those elements allow readers to distinguish an imprecise estimate from an absent one and to understand what the evidence can support. The entry records the study’s aims and limitations, but not a usable primary-outcome estimate.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important trial-specific limitation is the unavailable treatment assignment information. The registry states that the collaborator or corporate sponsor terminated the study prematurely and did not provide unblinding information to the investigator or study team. It consequently was not known which group each participant belonged to. This prevents a treatment-specific reading of the posted outcomes.
The registry lists no analyses and reports no numerical primary-endpoint results. It does not provide participant counts by treatment arm, apolipoprotein A-I values, variability, missing endpoint counts, or a treatment-effect estimate. The primary outcome description is incomplete in the record. These gaps mean the intended comparison cannot be evaluated for magnitude, direction, or precision.
The enrollment is recorded as 24, but the record does not say how many participants completed the 12-week treatment period or contributed an endpoint measurement. It also does not report reasons for withdrawal, adherence, concomitant statin details, or the analysis population. The reason for premature termination is not reported in the registry record.
Safety information is presented under a combined “Trilipix or Placebo” label, so serious and other adverse-event counts cannot be compared by treatment. The death count is not reported. The record does not offer details that would permit a more specific safety assessment.
Finally, the registry does not report the randomization procedure, allocation concealment, masking roles, statistical model, missing-data strategy, multiplicity approach, or sample-size justification. These are limitations of the available record and should not be filled in by assumption. They leave substantial uncertainty about the conduct and intended analysis beyond the design labels and treatment descriptions that are posted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Trilipix Effects on Lipids and Arteries — NCT01025492.
- Registry record last updated 2016-09-01; status last verified 2016-07.
- Results first posted 2016-09-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry identifies NCT01025492 as a Phase 4 randomized, quadruple-masked, parallel-group study of Trilipix compared with matching placebo, added to ongoing statin treatment. The listed Trilipix regimen was 135 mg orally once daily for 12 weeks; the placebo was taken on the same schedule. The study concerned subjects with insulin resistance, hypertriglyceridemia, and low HDL-C.
Enrollment is recorded as 24. The study start is listed as 2009-11, primary completion as 2011-03, and status as terminated. The primary endpoint was serum apolipoprotein A-I concentration at 12 weeks. No analyses or numerical primary-outcome results are reported in the registry record.
The entry states that the study was terminated prematurely and that unblinding information was not provided to the investigator or study team, leaving participant treatment assignments unknown. Adverse-event counts are reported for the combined “Trilipix or Placebo” group rather than by arm. These limitations prevent interpretation of a treatment-specific efficacy or safety comparison.