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 A Study of Evacetrapib in Participants With Abnormal Cholesterol (NCT02168803), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02168803 |
| Phase | Phase 1 |
| Condition | Dyslipidemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 101 |
| Arms in the primary outcome | 4 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with dyslipidemia, described in the registry record as having abnormal cholesterol and/or fat in the bloodstream. The primary pharmacokinetic population is described as enrolled participants who received at least 1 dose of study drug and had evaluable PK data.
Intervention
Oral evacetrapib. The registry describes a single dose on Day 1 and daily dosing beginning on Day 8 in groups followed for 12, 24, or 52 consecutive weeks. The dose amount is not reported in the registry record.
Comparator
There is no separate placebo or untreated comparator arm in the listed interventions. The arms describe different dosing schedules or durations of evacetrapib; comparisons between them should not be treated as randomized drug-versus-control comparisons.
Primary question
How does evacetrapib exposure, measured by the area under its concentration-versus-time curve through the last measurable concentration, appear after a single dose and after repeated daily dosing? The study also describes pharmacodynamic lipid measures and collects side-effect information.
The study focuses on pharmacokinetics: the concentration of drug in the bloodstream over time and the body’s handling of that drug. AUC combines concentration measurements over a stated interval into an exposure measure. Repeated-dose observations can help characterize exposure over time, including the potential for accumulation, which is part of the study’s stated purpose. The record also describes evaluating how the body responds during treatment and returns toward normal after treatment ends, but detailed results for that description are not reported in the registry record.
The posted primary results are geometric mean AUC values for the single-dose and multiple-dose groups. These are descriptive summaries; the registry record does not provide a separate placebo comparison or a reported inferential test between durations. It therefore supports a description of the reported exposure estimates, not a conclusion that one schedule is statistically different from another.
3. Trial Design
This is a Phase 1b randomized, open-label, parallel-group study of evacetrapib in participants with dyslipidemia. The registry record lists no masking. Its stated purpose is to characterize pharmacokinetics and the potential for accumulation after dosing for 12, 24, and 52 weeks. It also says that side-effect information would be collected and that pharmacodynamic responses could be evaluated.
The listed arms are a single oral dose on Day 1 and daily oral dosing beginning on Day 8 for 12, 24, or 52 consecutive weeks. All listed arms receive evacetrapib. Thus the parallel groups represent different dosing schedules or durations, rather than evacetrapib versus placebo or no treatment. The amount of evacetrapib administered is not reported in the registry record. The allocation ratio and details of the randomization process are also not reported in the registry record.
The record lists enrollment of 101 participants. The primary endpoint population is described as enrolled participants who received at least 1 dose and had evaluable PK data. The posted PK summaries report group sizes of 101.0 for the single-dose group, 27.0 for the 12-week group, 30.0 for the 24-week group, and 29.0 for the 52-week group. These are the sizes attached to the reported endpoint summaries; the record does not explain any differences between these endpoint counts and the adverse-event risk-group counts.
The study is marked completed. Its listed start is 2014-05, and primary completion is recorded as 2015-12. No protocol details beyond those summarized in the registry record, including further schedule details or the rationale for the chosen group sizes, are reported in the registry record. The design is useful for describing exposure under the listed schedules, but the absence of a separate control arm and the open-label design limit what can be inferred about comparative treatment effects.
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: Participants were enrolled into 3 parallel cohorts. Each participant received a single dose, after which PK was evaluated for 7 days, and then continued receiving once daily doses for 12, 24, or 52 weeks. After the last once-daily dose, PK was again evaluated in each participant until the concentration of evacetrapib was too low to be measurable.
Overall Study
| Stage | Evacetrapib: Multiple Dose 12 Weeks | Evacetrapib: Multiple Dose 24 Weeks | Evacetrapib: Multiple Dose 52 Weeks |
|---|---|---|---|
| STARTED | 30 | 32 | 39 |
| Received at Least 1 Dose of Study Drug | 30 | 32 | 39 |
| COMPLETED | 28 | 29 | 33 |
| NOT COMPLETED | 2 | 3 | 6 |
Reasons for not completing this period:
| Reason | Evacetrapib: Multiple Dose 12 Weeks | Evacetrapib: Multiple Dose 24 Weeks | Evacetrapib: Multiple Dose 52 Weeks |
|---|---|---|---|
| Lost to Follow-up | 1 | 0 | 1 |
| Withdrawal by Subject | 1 | 1 | 2 |
| Physician Decision | 0 | 1 | 0 |
| Adverse Event | 0 | 1 | 1 |
| Death | 0 | 0 | 1 |
| Sponsor Decision | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.
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.
| Characteristic | Unit | Evacetrapib: Multiple Dose 12 Weeks | Evacetrapib: Multiple Dose 24 Weeks | Evacetrapib: Multiple Dose 52 Weeks | Total |
|---|---|---|---|---|---|
| Participants analysed | 30 | 32 | 39 | 101 | |
| Age, Continuous | years | 53.2 (SD 14.5) | 51.1 (SD 14.9) | 56.4 (SD 9.4) | 53.8 (SD 13.0) |
| Sex: Female, Male: Female | Participants | 17 | 18 | 20 | 55 |
| Sex: Female, Male: Male | Participants | 13 | 14 | 19 | 46 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 | 2 | 6 | 13 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 25 | 30 | 33 | 88 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 2 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 8 | 9 | 27 |
| Race (NIH/OMB): White | Participants | 20 | 23 | 28 | 71 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 30 | 32 | 39 | 101 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]), measured over Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanogram∙hour/mililliter (ng∙h/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is AUC from time zero to the last time point with a measurable concentration, abbreviated AUC[0-tlast]. It is reported in nanogram∙hour/mililliter (ng∙h/mL) as a geometric mean, with geometric coefficient of variation (GCV) as the measure of dispersion. The listed sampling schedule includes postdose measurements after the single dose and, for multiple dosing, predose and postdose measurements extending through the dosing period.
In general, AUC represents the area under a drug concentration-versus-time curve. It summarizes exposure across the measured interval, rather than describing only a single concentration. Integrating measurements makes it useful for characterizing how much drug exposure is observed over time. AUC[0-tlast] ends at the last measurable concentration, so it is tied to the observed sampling window and does not by itself describe concentrations after that point.
AUC is not interchangeable with peak concentration, time to peak concentration, or a direct measure of how quickly the body eliminates a drug. Those questions require other PK parameters or analyses. Although accumulation is named as an aim, the posted endpoint values alone do not provide a formal test of accumulation or a reported comparison between dosing durations.
The reported geometric mean summarizes the group on a multiplicative scale, which is commonly used for pharmacokinetic measurements that vary proportionally. The GCV describes relative variability among observations; it is not a confidence interval and does not indicate how precisely the group mean was estimated. Confidence intervals for the endpoint are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results report geometric mean AUC[0-tlast] of 14200.0 ng∙h/mL for the single-dose group, with GCV 28.0. For multiple dosing, the reported values are 37400.0 ng∙h/mL with GCV 43.0 for 12 weeks, 36900.0 ng∙h/mL with GCV 39.0 for 24 weeks, and 44400.0 ng∙h/mL with GCV 32.0 for 52 weeks. The endpoint summary lists group sizes of 101.0, 27.0, 30.0, and 29.0, respectively.
These are descriptive group summaries. They show the recorded exposure estimates for the listed schedules, but they do not establish whether differences between those estimates are statistically distinguishable. The registry record contains no reported analyses for these outcomes, and it does not provide confidence intervals, standard errors, p-values, or a specified comparison between the dosing groups. A formal inference about differences cannot be reconstructed from the posted values alone.
The values should also be interpreted in light of the design. All listed groups received evacetrapib, and their schedules differ. The single-dose and multiple-dose groups are not a drug-versus-placebo comparison. In addition, the posted record does not state whether there were other differences in participant characteristics, timing, or study procedures across groups. Randomized allocation is listed, but details about the randomization and allocation ratio are not reported in the registry record.
GCV describes relative spread within a group. The reported GCV values indicate that individual measurements varied around their respective geometric means, but GCV is not a measure of uncertainty in the mean. General statistical interpretation distinguishes dispersion among participants from uncertainty about a group estimate: the latter is typically conveyed with an interval estimate or standard error, neither of which is reported for this endpoint.
The registry’s stated interest in potential accumulation is relevant to the choice of repeated-dose observations, but the posted summaries do not specify a prespecified accumulation contrast or report a test of accumulation. A comparison of geometric means across the displayed durations would not, on its own, establish that duration caused a change in exposure. The record also does not report the time-specific concentration profiles or detailed results needed to assess how exposure changed during each dosing period.
Four secondary outcomes are named in the record: HDL-C, LDL-C, total cholesterol, and triglyceride levels. The record lists seven outcome measures overall, but the detailed results for additional measures and analyses are not reported in the registry record. Consequently, the lipid outcomes cannot be interpreted from the names of those measures alone. No comparative effect estimates or uncertainty measures for them are included in the posted results.
9. Statistical Methods Explained
Interpretation of the posted pharmacokinetic results depends on distinguishing the endpoint, the group summaries, and the uncertainty around those summaries. The endpoint is AUC[0-tlast], a measure of cumulative concentration over the observed interval. The posted values are geometric means, and the accompanying GCV values describe relative variability. These statistics answer different questions: the geometric mean summarizes the group’s exposure on a multiplicative scale, while the GCV describes spread among its observations.
What does AUC measure?
In general, the area under a concentration-versus-time curve combines the measured concentrations across time. It can be useful when a single concentration would give an incomplete picture of exposure. AUC[0-tlast] is specifically bounded by time zero and the last time point with measurable concentration. Since the endpoint ends at that observed point, it is not necessarily the full area over all possible time, and it is not a direct summary of every feature of the concentration curve.
The registry lists sampling after the single dose at specified postdose times. For multiple dosing, it lists predose and postdose sampling and later observations during the dosing period. The concentration sampling schedule defines the data that can contribute to the PK characterization. The record does not report individual concentration profiles, missing-measurement details, or an approach for values below measurement limits.
Why use a geometric mean?
In general, pharmacokinetic measurements can be positively skewed and can differ multiplicatively between individuals. A geometric mean summarizes values after taking their logarithms and then returning to the original scale. It can be more suitable than an arithmetic mean for such data, although the registry record does not provide a distributional assessment or explain the choice of summary statistic. The posted results identify the geometric mean as the endpoint parameter.
The GCV is a relative measure of dispersion. It helps describe how much individual observations vary around the group’s typical exposure, but it does not give the precision of the estimated geometric mean. A confidence interval addresses uncertainty in an estimate, whereas a dispersion statistic describes variation among observations. Confidence intervals and standard errors are not reported for the AUC results in the registry record.
What can be inferred from the group summaries?
The AUC values and GCVs support descriptive statements about the reported groups. They do not supply a direct statistical test of differences across the schedules. Such a comparison would require a defined estimand and a reported method for estimating the difference, along with an uncertainty measure. The registry record does not report a statistical analysis for these endpoint results. It also does not state whether the analysis used covariate adjustment, a transformation beyond the geometric-mean summary, or a particular method for handling incomplete PK data.
General statistical reasoning cautions against treating group-level differences as causal effects merely because allocation is listed as randomized. The details of allocation, the analysis population, and the handling of participants without evaluable measurements all matter. Here, the endpoint population is described as those enrolled participants who received at least 1 dose and had evaluable PK data, but further inclusion and exclusion details are not reported in the registry record.
Why are the duration groups not a conventional control comparison?
The listed arms all receive evacetrapib, with differing schedules or durations. A placebo or untreated arm is not listed. The values can therefore be presented as exposure estimates under the regimens described, but they do not directly quantify exposure relative to no treatment. The registry record does not report a planned pairwise contrast, a trend test across durations, or a formal accumulation analysis.
The sample-size illustrations associated with the posted results are planning exercises based on observed effects and stated assumptions, rather than observed power calculations for this completed study. In general, such illustrations ask how many participants per arm might be needed under an assumed effect and statistical model. They do not change the uncertainty of the estimates already observed and are not evidence that the study had a particular probability of detecting an effect. The registry record does not report the trial’s own sample-size justification or design calculations.
How should missing analyses be understood?
The record lists no posted analyses for the reported outcomes. That absence means inferential results such as adjusted comparisons, tests, and interval estimates are not reported in the registry record. It does not establish that no analyses were performed outside the posted record. Without those details, readers should keep descriptive summaries separate from statistical claims about differences, accumulation, or relationships between drug exposure and pharmacodynamic response.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names four secondary pharmacodynamic outcomes: HDL-C, LDL-C, total cholesterol, and triglyceride levels. It also lists seven outcome measures overall. The detailed results for all measures are not reported in the registry record, and no multiplicity procedure is reported. In general, testing several outcomes or contrasts can increase the chance of at least one apparently notable result by chance. Methods such as prespecifying a primary comparison or adjusting for multiple testing can address that issue, but the registry record does not state whether such methods were planned or used.
No statistical analysis is listed for the posted outcomes. The record does not report an analysis plan, a hierarchy among secondary outcomes, or a correction for multiple comparisons. It is therefore not possible to determine how any unreported testing was handled, or whether the endpoint summaries were part of a broader inferential analysis.
The primary endpoint population is defined as enrolled participants who received at least 1 dose and had evaluable PK data. The record does not provide the number screened, the number excluded from this population, reasons for missing or unevaluable PK data, or any missing-data method. It also does not report whether all randomized participants were analyzed according to assigned group or whether another analysis set was used. Those details are important because excluding participants with unavailable measurements can affect how well a summary represents the randomized groups.
In general, missing data are not automatically handled by simply omitting them; the appropriate approach depends on why measurements are missing and on the planned estimand. The registry record does not describe the missingness assumptions or sensitivity analyses. Thus the displayed endpoint summaries should be read as summaries for the reported evaluable population, without assuming that missing observations had a particular value or were missing for a particular reason.
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 |
|---|---|---|---|
| Evacetrapib: Single Dose, All Participants | 0 | 101 | 0.0% |
| Evacetrapib: Multiple Dose 12 Weeks | 0 | 30 | 0.0% |
| Evacetrapib: Multiple Dose 24 Weeks | 0 | 32 | 0.0% |
| Evacetrapib: Multiple Dose 52 Weeks | 5 | 39 | 12.8% |
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 |
|---|---|
| Evacetrapib: Single Dose, All Participants | 12 of 101 |
| Evacetrapib: Multiple Dose 12 Weeks | 13 of 30 |
| Evacetrapib: Multiple Dose 24 Weeks | 17 of 32 |
| Evacetrapib: Multiple Dose 52 Weeks | 22 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | Evacetrapib: Single Dose, All Participants | Evacetrapib: Multiple Dose 12 Weeks | Evacetrapib: Multiple Dose 24 Weeks | Evacetrapib: Multiple Dose 52 Weeks |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Myocardial infarction | Cardiac disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Sudden death | General disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Cholecystitis acute | Hepatobiliary disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Mycetoma mycotic | Infections and infestations | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
| Deep vein thrombosis | Vascular disorders | 0 of 101 | 0 of 30 | 0 of 32 | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Evacetrapib: Single Dose, All Participants | Evacetrapib: Multiple Dose 12 Weeks | Evacetrapib: Multiple Dose 24 Weeks | Evacetrapib: Multiple Dose 52 Weeks |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 7 of 101 | 4 of 30 | 3 of 32 | 3 of 39 |
| Upper respiratory tract infection | Infections and infestations | 0 of 101 | 1 of 30 | 4 of 32 | 5 of 39 |
| Diarrhoea | Gastrointestinal disorders | 1 of 101 | 2 of 30 | 3 of 32 | 2 of 39 |
| Back pain | Musculoskeletal and connective tissue disorders | 3 of 101 | 1 of 30 | 0 of 32 | 4 of 39 |
| Dyspepsia | Gastrointestinal disorders | 2 of 101 | 2 of 30 | 1 of 32 | 1 of 39 |
| Nausea | Gastrointestinal disorders | 1 of 101 | 3 of 30 | 1 of 32 | 1 of 39 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 101 | 3 of 30 | 3 of 32 | 0 of 39 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 101 | 0 of 30 | 2 of 32 | 4 of 39 |
| Urinary tract infection | Infections and infestations | 0 of 101 | 0 of 30 | 2 of 32 | 2 of 39 |
| Viral upper respiratory tract infection | Infections and infestations | 0 of 101 | 1 of 30 | 1 of 32 | 2 of 39 |
Serious events with the highest arm-level rate: atrial fibrillation (2.6%), myocardial infarction (2.6%), sudden death (2.6%), cholecystitis acute (2.6%), mycetoma mycotic (2.6%).
The registry reports serious adverse events for each listed group, alongside other adverse events. The serious-event counts are 0 among 101 at risk in the single-dose group, 0 among 30 at risk in the 12-week group, 0 among 32 at risk in the 24-week group, and 5 among 39 at risk in the 52-week group. These are counts recorded for the groups; the record does not provide a comparative statistical analysis or confidence intervals.
The registry also lists six serious-event terms at 2.6% each: atrial fibrillation, myocardial infarction, sudden death, acute cholecystitis, mycetoma mycotic, and clear cell renal cell carcinoma. The record does not explain the denominator or observation period underlying those term-specific percentages, nor does it state whether a term occurred in more than one participant. The terms should not be added together or treated as mutually exclusive without further information.
Other adverse events are reported as 12 among 101 at risk for the single-dose group, 13 among 30 for 12 weeks, 17 among 32 for 24 weeks, and 22 among 39 for 52 weeks. The definition and severity threshold for this category are not reported in the registry record. Death counts by group are not reported in the registry record.
These safety figures are descriptive. Group sizes and exposure durations differ, and there is no separate untreated or placebo group listed. The counts therefore do not establish comparative risks or attribute events to evacetrapib.
12. What the Result Does, and Does Not, Mean
The posted results describe pharmacokinetic exposure under the evacetrapib schedules listed in the registry record. For AUC[0-tlast], they provide a geometric mean and GCV for the single-dose group and each multiple-dose duration group. This enables readers to see the recorded exposure summaries and the degree of within-group variability represented by the GCV values.
The results do not establish that one dosing duration produces a statistically different exposure from another. No inferential comparisons, confidence intervals, or p-values for the primary endpoint are reported in the registry record. The record also does not report a specific statistical test of accumulation. The stated purpose includes characterizing potential accumulation, but the posted summaries alone do not answer that question with a reported formal analysis.
Because every listed arm receives evacetrapib, the record does not provide a direct comparison with placebo or no treatment. It is not possible to use these summaries to estimate a drug-versus-control effect. Nor should the group values be interpreted as evidence of clinical benefit or lack of benefit. They are PK summaries, not clinical outcome comparisons.
The study also lists lipid measures and safety collection. The named secondary outcomes include HDL-C, LDL-C, total cholesterol, and triglyceride levels, but detailed results for those outcomes are not reported in the registry record. Serious and other adverse-event counts are available as descriptive summaries, but the record does not provide comparative safety analyses or enough detail to interpret the listed term-specific percentages fully.
In general, a registry result is most informative when its population, endpoint, estimate, uncertainty, and analysis are all described. Here, the endpoint definition and descriptive estimates are available, while important inferential details are not. The appropriate conclusion is consequently limited to what was recorded: the study reports group-level PK exposure summaries and selected event counts under the listed regimens. Claims about statistical significance, comparative effects, clinical outcomes, or causation are not supported by the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a study’s objective shapes its endpoint. The stated question concerns pharmacokinetics and potential accumulation, so the primary measure is AUC over an observed concentration-time interval rather than a clinical outcome. AUC summarizes exposure across multiple measurements, while the geometric mean and GCV communicate a typical group value and relative variability.
The design also illustrates why endpoint summaries need to be read alongside the arm structure. The listed arms receive the same study drug but have different schedules or durations, and there is no separate placebo or untreated arm. The results therefore describe exposure in the specified groups, not a conventional comparative treatment effect. The listed randomized allocation does not remove the need to know which contrasts were planned and how they were analyzed; those details are not reported in the registry record.
Another statistical lesson is the difference between variability and precision. The GCVs describe variation among observations. They do not replace confidence intervals for the group estimates. Without uncertainty intervals or a reported inferential analysis, the descriptive values cannot answer whether apparent differences are distinguishable from sampling variability.
The record also highlights the value of complete reporting. It identifies a primary PK endpoint, names secondary lipid outcomes, and records adverse-event counts, but does not report the statistical analysis, missing-data handling, or multiplicity approach. Those omissions constrain interpretation even when summary numbers are available. The resulting distinction—between a measured quantity and an inferential conclusion—is central to reading clinical trial statistics carefully.
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 posted record leaves several trial-specific questions unresolved. Although randomized allocation is listed, the allocation ratio, randomization procedure, and any stratification factors are not reported in the registry record. Masking is listed as none. The dose amount and the rationale for the dosing schedules are also not reported, limiting the detail with which the exposure regimens can be interpreted.
The primary endpoint results are descriptive geometric means and GCVs. Confidence intervals, standard errors, p-values, and formal comparisons are not reported. The registry record does not state how the potential for accumulation was defined analytically or whether a prespecified accumulation contrast was evaluated. Detailed concentration-time results are not reported, so the group AUC summaries cannot show the shape of the concentration profiles.
The stated endpoint population requires receipt of at least 1 dose and evaluable PK data, but the record does not describe missing measurements, exclusions, or sensitivity analyses. It also does not explain the differences between PK summary group sizes and adverse-event risk-group counts. No analysis population beyond the PK description is specified.
Although four secondary lipid outcomes are named and seven measures are listed overall, detailed results for all measures and any multiplicity strategy are not reported in the registry record. Safety information is also limited: definitions and observation periods for the adverse-event categories, term-specific percentage denominators, and group death counts are not reported. The absence of a listed control group further limits comparative interpretation of both exposure and safety. These gaps make the record most useful for describing the posted summaries, rather than drawing broader comparative conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Evacetrapib in Participants With Abnormal Cholesterol — NCT02168803.
- Registry record last updated 2018-10-03; status last verified 2018-02.
- Results first posted 2018-10-03.
- 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 record describes NCT02168803, a completed Phase 1b randomized, open-label, parallel-group study of evacetrapib in participants with dyslipidemia. The stated aim is to characterize pharmacokinetics and potential accumulation after single-dose or daily dosing schedules extending for 12, 24, or 52 weeks. Enrollment is recorded as 101, with a start of 2014-05 and primary completion of 2015-12.
The primary endpoint is geometric mean AUC[0-tlast], with GCV as the dispersion measure. The posted group summaries are descriptive; inferential analyses and uncertainty intervals are not reported in the registry record. The record also names lipid-related secondary outcomes and reports adverse-event counts, but detailed secondary analyses and several safety details are not reported. No separate placebo or untreated arm is listed.