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 To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity (NCT04621227), a na phase 1 study. The primary outcome is Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04621227 |
| Phase | Phase 1 |
| Condition | Obesity |
| Allocation | Not applicable (single group) |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Otherwise healthy adult participants with obesity. The registry record reports an enrollment of 16 participants. The primary pharmacokinetic analysis population was defined as participants who received at least one dose of rosuvastatin and had at least one of the pharmacokinetic parameters of interest calculated.
Intervention
PF-06882961 at two dose levels: 120 mg twice daily and 200 mg twice daily. The sequence also included periods of PF-06882961 alone and periods combining it with rosuvastatin or midazolam. The registry describes titration periods before the higher-dose combination periods.
Comparator
Single doses of rosuvastatin or midazolam without PF-06882961, compared with their use alongside PF-06882961 in later study periods. The primary endpoint specifically concerns rosuvastatin in Periods 1, 4 and 7. The study was open-label and fixed-sequence, not a randomized comparison.
Primary question
How did the area under the plasma concentration-time profile for rosuvastatin, from time 0 to the last quantifiable concentration, compare across the specified periods? The endpoint was intended to describe rosuvastatin exposure when given alone and with the two PF-06882961 dose levels. Numerical endpoint results are not reported in the registry record.
3. Trial Design
This was a Phase 1, open-label, fixed-sequence study with a crossover model. It enrolled 16 otherwise healthy adult participants with obesity, was sponsored by Pfizer, and is listed as completed. The recorded study start was 2020-12-15, and primary completion was 2021-05-13. Allocation is listed as NA and masking as none.
The sequence included rosuvastatin alone in Period 1, midazolam alone in Period 2, and PF-06882961 titration up to 120 mg twice daily in Period 3. Period 4 combined PF-06882961 120 mg twice daily with rosuvastatin 10 mg, and Period 5 combined the 120 mg twice-daily dose with midazolam 2 mg. Period 6 was titration up to 200 mg twice daily; Periods 7 and 8 paired that dose with rosuvastatin 10 mg and midazolam 2 mg, respectively. Rosuvastatin alone was listed as a single dose of 10 mg, and midazolam alone as a single dose of 2 mg.
The primary endpoint compared rosuvastatin AUClast in Periods 1, 4 and 7. The stated sampling schedule ran from the predose time through 72 hours after rosuvastatin dosing. These period-based measurements fit the crossover model, but the fixed order means treatment conditions were not assigned in a randomized order. Washout arrangements, sequence rationale, and details about how period effects were addressed are not reported in the registry record.
The registry lists secondary safety and tolerability outcomes, including treatment-emergent adverse events, laboratory abnormalities, vital signs, body weight, electrocardiogram findings, Columbia Suicide Severity Rating Scale responses, and Patient Health Questionnaire scores. Numerical results for these secondary measures are not reported in the registry record beyond the adverse-event figures.
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.
Period 1 (5 Days)
| Stage | All Participants |
|---|---|
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Period 2 (2 Days)
| Stage | All Participants |
|---|---|
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Period 3 (29 Days)
| Stage | All Participants |
|---|---|
| STARTED | 16 |
| COMPLETED | 14 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | All Participants |
|---|---|
| Physician decision due to inappropriate behavior and noncompliance | 1 |
| Adverse Event | 1 |
Period 4 (4 Days)
| Stage | All Participants |
|---|---|
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The PK parameter analysis population was defined as all participants who received at least 1 dose of rosuvastatin and had at least 1 of the PK parameters of interest calculated.
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: All enrolled participants who received at least 1 dose of study intervention
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | Years | 49.0 (SD 11.34) |
| Age, Customized: <18 Years | Participants | 0 |
| Age, Customized: 18-44 Years | Participants | 5 |
| Age, Customized: 45-65 Years | Participants | 11 |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 8 |
| Race/Ethnicity, Customized: White | Participants | 12 |
| Race/Ethnicity, Customized: Black or African American | Participants | 3 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7, measured over At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanogram*hour per milliliter (ng*hr/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the plasma concentration-time profile from time 0 to the last quantifiable concentration, abbreviated AUClast, for rosuvastatin. It is expressed in nanogram*hour per milliliter (ng*hr/mL). The registry describes the endpoint as a geometric mean, with geometric coefficient of variation as its dispersion measure. Measurements were scheduled at 0 hours before dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours after the rosuvastatin dose in Periods 1, 4 and 7.
In general, an area under a concentration-time profile captures drug exposure over the measured interval: it reflects both concentrations and how long they are observed. AUClast is limited to the last quantifiable concentration rather than necessarily extending to an extrapolated end of the concentration profile. The geometric mean is commonly used for positive pharmacokinetic measurements that can be analyzed on a multiplicative scale. The geometric coefficient of variation describes relative variability around that geometric mean; it is not a confidence interval and does not by itself show the precision of a treatment comparison.
Comparing the endpoint across the periods was intended to describe rosuvastatin exposure alone and alongside PF-06882961 at the two dose levels. The registry record gives the endpoint definition and analysis population, but not the period-specific geometric means, coefficients of variation, treatment contrasts, or confidence intervals. Therefore, the size and precision of any difference in exposure cannot be assessed from the recorded endpoint information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and design, but it does not report numerical results for the primary pharmacokinetic endpoint. In particular, no period-specific AUClast estimates, comparison estimates, confidence intervals, or p-values are included in the record. The primary endpoint is defined as a geometric mean for rosuvastatin in Periods 1, 4 and 7, with geometric coefficient of variation as the dispersion measure. That definition alone does not reveal whether the measured exposure differed between periods or how precisely any difference was estimated.
The study's treatment sequence makes the intended comparisons identifiable at the descriptive level: rosuvastatin alone was scheduled in Period 1, and rosuvastatin was paired with PF-06882961 120 mg twice daily and 200 mg twice daily in Periods 4 and 7. Midazolam was also studied alone and alongside the two PF-06882961 dose levels, but no numerical midazolam pharmacokinetic results are reported in the registry record. The inclusion of both probe drugs does not mean their results can be inferred from the rosuvastatin endpoint.
The posted adverse-event counts give a separate description of safety observations across periods. No serious adverse events were recorded for Periods 1 through 7; one participant was recorded with a serious adverse event in Period 8. No deaths were recorded in any period. Other adverse events were recorded for 0 participants in Period 1, 2 in Period 2, 13 in Period 3, 6 in Period 4, 5 in Period 5, 11 in Period 6, 7 in Period 7, and 8 in Period 8. The corresponding numbers at risk were 16 for Periods 1 through 3 and 14 for Periods 4 through 8. These counts are period-specific and are not a randomized comparison of treatment groups.
In general, a treatment contrast is easier to interpret when its estimate is accompanied by an uncertainty interval. A confidence interval conveys a range of values compatible with the data and analysis assumptions; its width reflects precision. Without the estimates and intervals, neither the magnitude of an exposure contrast nor its uncertainty can be assessed. A p-value, if reported, would address compatibility with a specified null model, but would not by itself establish the size or practical importance of a contrast.
The record lists 16 enrolled participants, but does not provide a numerical result for the primary analysis population or explain the difference between the 16 participants at risk in early periods and the 14 at risk in later periods. Reasons for that change are not reported in the registry record. Taken together, the record supports an account of the planned pharmacokinetic question and the posted safety counts, not a conclusion about the direction or size of the primary endpoint result.
9. Statistical Methods Explained
What does the endpoint estimate?
The primary measure is AUClast, the area under the plasma concentration-time profile from time 0 to the last quantifiable concentration. In general, an area-under-the-curve measure summarizes exposure over the observed sampling interval, rather than focusing on a single concentration at one time. The registry specifies a geometric mean for this pharmacokinetic parameter and a geometric coefficient of variation for dispersion. It does not report the numerical geometric means or variability estimates for the three periods named in the primary endpoint.
Concentration samples were scheduled before the rosuvastatin dose and through 72 hours after dosing, at the times listed in the endpoint definition. The concentration-time measurements are the basis for the area, but the registry record does not report individual concentration profiles, the last quantifiable time for participants, or details of how values below quantification were handled. Those details matter because the observed interval and the handling of unquantifiable measurements can affect an exposure summary.
Why use a geometric summary?
General statistical explanation: pharmacokinetic parameters are positive and can have a right-skewed distribution. A geometric mean summarizes measurements on a multiplicative scale and can be useful when proportional changes are the scientific focus. A geometric coefficient of variation expresses variability relative to the geometric mean. It is not an uncertainty interval for a treatment effect, and it does not replace a confidence interval around a contrast.
The registry identifies the summary and dispersion measures, but does not state the transformation or model used to produce the primary comparison, whether the comparison was a ratio, or the method used to calculate uncertainty. These analytical details are not reported in the registry record. Accordingly, a particular model or contrast should not be inferred from the use of geometric means alone.
How should the crossover structure be understood?
In general, a crossover design measures participants under more than one treatment condition. Within-participant comparisons can account for stable differences between participants, which may be helpful when pharmacokinetic measurements vary across people. However, observations in different periods may also be affected by period-related changes or carryover from a prior treatment. The registry labels this study a crossover and gives a fixed sequence, but does not report washout details or how period and carryover effects were assessed.
Because the sequence was fixed and masking was absent, treatment conditions were not assigned in a randomized, blinded order. This matters when interpreting contrasts: the treatment condition and its position in the sequence are not independently varied in the way they would be in a randomized sequence. The record does not describe an adjustment for period effects or provide enough analysis results to evaluate such an adjustment.
What do the safety counts describe?
The adverse-event figures are counts of participants at risk and participants affected within each period, separated into serious and other adverse events, with deaths also listed. They are not estimates of the primary pharmacokinetic endpoint. In general, a participant count does not indicate the number of events if a participant could have more than one event; the registry's figures should be read as participant counts as labeled, not as event totals.
All listed serious-event counts are 0 except for Period 8, which records 1 participant affected among 14 at risk. The recorded death count is 0 in every period. Other adverse-event counts vary by period, and the number at risk is 16 in Periods 1 through 3 and 14 in Periods 4 through 8. These changing period denominators should be kept in view. The record does not state why the denominator changed, nor does it give a participant-level account of overlap across periods.
What analysis details remain unclear?
The registry record identifies a pharmacokinetic analysis population: participants who received at least one dose of rosuvastatin and had at least one pharmacokinetic parameter of interest calculated. It does not report how many participants met that definition for the primary endpoint, how missing concentration measurements were handled, or whether any participants were excluded from particular period comparisons.
The record lists 9 outcome measures and 4 analyses, but does not provide the full analysis specifications or numerical primary results. It also does not report a confidence level, inferential test, covariate adjustment, model diagnostics, or a prespecified equivalence or interaction margin. Without those details and results, the analysis cannot be reconstructed or independently evaluated from the registry entry alone.
The study's planning assumptions are described as a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. Those are planning-illustration assumptions, not the observed endpoint analysis. The associated numerical planning illustrations and the fractions are not reported in the registry record. Such illustrations should not be interpreted as observed power or as evidence that the study had a particular probability of detecting its result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures and 4 analyses. Its named secondary outcomes cover treatment-emergent adverse events, laboratory abnormalities, vital signs, body-weight change, electrocardiogram findings, Columbia Suicide Severity Rating Scale responses, and Patient Health Questionnaire scores. The primary pharmacokinetic endpoint also involves measurements across three periods, and the study includes midazolam pharmacokinetic assessments. However, a complete list of the statistical hypotheses and contrasts is not reported in the registry record.
In general, multiplicity arises when several hypotheses, outcomes, doses, or time points are examined. If each is tested separately, the chance of at least one result appearing noteworthy by chance can increase. Common approaches include designating a single primary contrast, adjusting significance thresholds, or using a testing hierarchy. The registry record does not report whether any such approach was specified or used. It also does not report a prespecified interpretation threshold for pharmacokinetic comparisons.
The primary pharmacokinetic analysis population is defined as participants who received at least one dose of rosuvastatin and had at least one pharmacokinetic parameter of interest calculated. The number included in each period comparison, and the handling of missing or incomplete pharmacokinetic data, are not reported in the registry record. The record likewise does not say whether all enrolled participants contributed to each safety outcome or how repeated observations across periods were handled in statistical analyses.
These omissions limit assessment of the analysis population, the potential effects of missing data, and how multiplicity may affect interpretation. They do not establish that a particular method was absent from the study protocol; they mean only that the method is not reported in the registry record.
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 |
|---|---|---|---|
| Rosuvastatin 10mg (Period 1) | 0 | 16 | 0.0% |
| Midazolam 2mg (Period 2) | 0 | 16 | 0.0% |
| PF-06882961 Titration up to 120mg BID (Period 3) | 0 | 16 | 0.0% |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 0 | 14 | 0.0% |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 0 | 14 | 0.0% |
| PF-06882961 Titration up to 200mg BID (Period 6) | 0 | 14 | 0.0% |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 0 | 14 | 0.0% |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 1 | 14 | 7.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rosuvastatin 10mg (Period 1) | 0 of 16 |
| Midazolam 2mg (Period 2) | 0 of 16 |
| PF-06882961 Titration up to 120mg BID (Period 3) | 0 of 16 |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 0 of 14 |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 0 of 14 |
| PF-06882961 Titration up to 200mg BID (Period 6) | 0 of 14 |
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 |
|---|---|
| Rosuvastatin 10mg (Period 1) | 0 of 16 |
| Midazolam 2mg (Period 2) | 2 of 16 |
| PF-06882961 Titration up to 120mg BID (Period 3) | 13 of 16 |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 6 of 14 |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 5 of 14 |
| PF-06882961 Titration up to 200mg BID (Period 6) | 11 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Rosuvastatin 10mg (Period 1) | Midazolam 2mg (Period 2) | PF-06882961 Titration up to 120mg BID (Period 3) | PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | PF-06882961 120mg BID + Midazolam 2mg (Period 5) | PF-06882961 Titration up to 200mg BID (Period 6) |
|---|---|---|---|---|---|---|---|
| Transaminases increased | Investigations | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 0 of 14 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rosuvastatin 10mg (Period 1) | Midazolam 2mg (Period 2) | PF-06882961 Titration up to 120mg BID (Period 3) | PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | PF-06882961 120mg BID + Midazolam 2mg (Period 5) | PF-06882961 Titration up to 200mg BID (Period 6) |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 8 of 16 | 5 of 14 | 0 of 14 | 4 of 14 |
| Constipation | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 10 of 16 | 0 of 14 | 0 of 14 | 1 of 14 |
| Vomiting | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 3 of 16 | 1 of 14 | 0 of 14 | 3 of 14 |
| Glomerular filtration rate decreased | Investigations | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 14 | 3 of 14 | 3 of 14 |
| Headache | Nervous system disorders | 0 of 16 | 0 of 16 | 6 of 16 | 0 of 14 | 0 of 14 | 1 of 14 |
| Dyspepsia | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 4 of 16 | 0 of 14 | 0 of 14 | 1 of 14 |
| Early satiety | General disorders | 0 of 16 | 0 of 16 | 5 of 16 | 0 of 14 | 0 of 14 | 0 of 14 |
| Abdominal pain | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 1 of 16 | 1 of 14 | 0 of 14 | 1 of 14 |
| Abdominal distension | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 3 of 16 | 0 of 14 | 0 of 14 | 0 of 14 |
| Dizziness | Nervous system disorders | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 14 | 1 of 14 | 1 of 14 |
Serious events with the highest arm-level rate: transaminases increased (7.1%).
The safety figures are reported by study period and distinguish serious adverse events from other adverse events. The number at risk was 16 in Periods 1 through 3 and 14 in Periods 4 through 8. Serious adverse events affected 0 participants in Periods 1 through 7 and 1 participant in Period 8. Deaths were recorded as 0 in every period. Other adverse events affected 0 participants in Period 1, 2 in Period 2, 13 in Period 3, 6 in Period 4, 5 in Period 5, 11 in Period 6, 7 in Period 7, and 8 in Period 8.
The registry also lists “Transaminases increased” as a top serious term, with 7.1%. It does not provide enough detail in the entry to connect that term to a particular period or to explain its relationship to the period-level participant count. The reason the number at risk changes from 16 to 14 is not reported in the registry record.
In general, these are descriptive counts, not randomized comparisons. Participants contributed observations across a fixed sequence, and the same participant may have been at risk in more than one period. The counts therefore should not be treated as independent group-level estimates or as proof of a causal difference between treatments. The registry record does not report a formal comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The record describes a Phase 1 study designed to examine rosuvastatin and midazolam pharmacokinetics when PF-06882961 was given at two dose levels. It identifies rosuvastatin AUClast in Periods 1, 4 and 7 as the primary endpoint and defines the pharmacokinetic analysis population. The posted safety figures provide period-specific participant counts for serious and other adverse events and deaths.
Those design details and safety counts do not establish what happened to rosuvastatin exposure. Numerical primary endpoint results, including geometric means and a treatment contrast, are not reported in the registry record. The record also does not report numerical midazolam pharmacokinetic results. It is therefore not possible to determine the direction, magnitude, or precision of the pharmacokinetic comparisons from the registry entry.
In general, a pharmacokinetic contrast answers a question about measured drug exposure under the conditions studied. It is not, by itself, evidence about clinical outcomes, effectiveness, or safety in other populations. This study concerned otherwise healthy adult participants with obesity and used an open-label fixed sequence. The record does not justify extending findings beyond the study population or treating period-based counts as randomized treatment effects.
The observed safety counts have a descriptive meaning: they report how many participants were recorded as affected in each period. They do not show the severity, timing, duration, or full clinical context of each event, and the record does not provide participant-level detail. The one serious adverse event recorded in Period 8 should be read alongside the period denominator and the fact that reasons for the change in at-risk counts are not reported.
In general, a result is more informative when its estimate, uncertainty, analysis population, and prespecified interpretation criteria are all available. Here, the endpoint definition and sequence are clear, but the numerical pharmacokinetic estimates and key inferential details are not reported in the registry record. The available information supports describing the study question, design, and posted safety counts; it does not support a conclusion about the size or clinical importance of a pharmacokinetic effect.
13. Why This Trial Matters Statistically
This study raises a focused statistical question: whether exposure to rosuvastatin, measured by AUClast, differed across periods in which rosuvastatin was given alone or alongside PF-06882961 at two dose levels. The repeated, period-based structure is relevant because pharmacokinetic measurements can vary between participants. A crossover design can make within-participant comparisons possible, while a fixed sequence makes period and treatment conditions difficult to separate unless the analysis addresses those features.
The registry record also illustrates why endpoint definitions and outcome estimates serve different purposes. Naming AUClast, its units, sampling schedule, summary scale, and analysis population clarifies what was intended to be measured. But without period estimates and an uncertainty measure, readers cannot judge the size or precision of the planned comparison. The endpoint definition alone is not a result.
Safety counts likewise require attention to their structure. The numbers at risk differ between early and later periods, and the sequence is not a randomized comparison. Reporting raw participant counts is useful descriptively, but it does not establish that any difference in counts is attributable to one treatment condition. The registry does not report the reasons for the denominator change or a formal comparative safety analysis.
More broadly, the record highlights the distinction between a planning illustration and observed evidence. The stated planning assumptions concern an illustrative calculation based on a fraction of an observed effect; they are not observed power. The numerical illustrations and observed endpoint effect are not reported in the registry record. For statistical interpretation, the central missing elements are the primary estimates, uncertainty intervals, and sufficient analysis details to assess the comparisons.
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 main limitation for interpreting the primary question is that numerical rosuvastatin AUClast results are not reported in the registry record. The record gives the endpoint definition, sampling schedule, summary measure, and analysis-population definition, but not period estimates, treatment contrasts, confidence intervals, or p-values. Midazolam pharmacokinetic results are also not reported in the registry record.
The fixed-sequence, open-label crossover design does not use randomized order or masking. A crossover can support within-participant comparisons in general, but fixed ordering makes period effects and treatment conditions difficult to disentangle without suitable design or analysis details. Washout periods, carryover assessment, and the handling of period effects are not reported in the registry record. The study therefore cannot be assessed for those features from the entry alone.
Although the registry reports enrollment of 16 and period-specific at-risk counts of 16 in Periods 1 through 3 and 14 in Periods 4 through 8, it does not explain the change. It does not report the number included in each pharmacokinetic comparison or describe missing observations and exclusions in detail. The listed analysis-population definition does not resolve those questions.
Safety information is similarly limited to period-level participant counts, a listed serious-event term with 7.1%, and death counts. Event timing, duration, severity details, overlap across periods, and a formal comparative analysis are not reported in the registry record. The counts should not be read as independent randomized groups. Finally, the registry entry does not report multiplicity handling or the full statistical analysis plan, limiting assessment of how the multiple outcomes and comparisons were interpreted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity — NCT04621227.
- Registry record last updated 2023-12-01; status last verified 2023-02.
- Results first posted 2023-12-01.
- 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
This completed Phase 1, open-label, fixed-sequence crossover study enrolled 16 otherwise healthy adult participants with obesity. It examined PF-06882961 at 120 mg twice daily and 200 mg twice daily in a sequence that included rosuvastatin and midazolam alone and in combination periods. The primary endpoint was rosuvastatin AUClast in Periods 1, 4 and 7, summarized as a geometric mean with geometric coefficient of variation.
The registry record does not report numerical primary or midazolam pharmacokinetic results. Its safety figures record no serious adverse events in Periods 1 through 7 and 1 participant affected in Period 8; deaths are recorded as 0 across periods. Other adverse-event counts and changing period denominators are descriptive and not randomized comparisons. Washout details, reasons for the denominator change, missing-data handling, and multiplicity methods are not reported in the registry record.