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 Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants (NCT05515601), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05515601 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 396 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants were eligible for the study. The primary pharmacokinetic analysis included participants who received at least one dose of mirikizumab and had evaluable pharmacokinetic data. The registry record also lists exclusions from that analysis for device malfunction, receipt of only one of the two autoinjector doses, or an incorrect administration; the final exclusion description is truncated in the registry record.
Intervention
The test treatment was 200 mg of mirikizumab in the test formulation, delivered as two 1-mL subcutaneous injections through an investigational 1-mL autoinjector on Day 1. The injection could be administered into the arm, thigh, or abdomen.
Comparator
The comparator was 200 mg of mirikizumab in the reference formulation, also delivered as two 1-mL subcutaneous injections through an investigational 1-mL autoinjector on Day 1. The available arm descriptions list the same possible injection sites for both formulations.
Primary question
The study compared maximum mirikizumab concentration in blood, or Cmax, after the test and reference formulations. The posted comparison is a ratio of geometric least-squares means: 0.986, with a 90% confidence interval from 0.929 to 1.05. The registry record does not report an equivalence margin, so this estimate alone does not establish whether a prespecified equivalence criterion was met.
3. Trial Design
This was a Phase 1 randomized, single-masked, parallel-group study in healthy participants. Its stated purpose was to compare the amount of mirikizumab reaching the bloodstream and how long it takes the body to eliminate it when the test and reference formulations are delivered by autoinjector. The study also collected information about adverse effects and tolerability. The posted primary endpoint concerns maximum concentration, rather than the full set of pharmacokinetic questions described in the study summary.
Participants were assigned to a reference-formulation arm or a test-formulation arm. Both arm descriptions specify 200 mg administered subcutaneously on Day 1, using two 1-mL autoinjectors, with administration to the arm, thigh, or abdomen. The registry lists a total enrollment of 396. The primary pharmacokinetic results list 196 participants for the reference arm and 192 for the test arm; those are the arm counts associated with the posted Cmax summaries. The registry record does not explain the difference between the enrollment count and the counts in this analysis.
The listed study start was 2022-08-31, and primary completion was 2023-02-20. The study is marked completed. Screening was required within 35 days before enrollment, and the brief summary describes an overall duration of about 17 weeks per participant, including screening. Blood sampling for the primary endpoint was listed from predose on Day 1 through Day 85 postdose, with specified visits on Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, and Day 71 as well as Day 85. The registry record does not report additional protocol details such as the allocation procedure, masking procedures, or a sample-size justification.
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.
Overall Study
| Stage | 200 Milligram (mg) Mirikizumab (Reference): Abdomen | 200 mg Mirikizumab (Reference): Arm | 200 mg Mirikizumab (Reference): Thigh | 200 mg Mirikizumab (Test): Abdomen | 200 mg Mirikizumab (Test): Arm | 200 mg Mirikizumab (Test): Thigh |
|---|---|---|---|---|---|---|
| STARTED | 63 | 69 | 67 | 66 | 66 | 65 |
| Received at Least 1 Dose of Study Drug | 63 | 69 | 67 | 66 | 66 | 65 |
| COMPLETED | 62 | 66 | 65 | 65 | 64 | 64 |
| NOT COMPLETED | 1 | 3 | 2 | 1 | 2 | 1 |
Reasons for not completing this period:
| Reason | 200 Milligram (mg) Mirikizumab (Reference): Abdomen | 200 mg Mirikizumab (Reference): Arm | 200 mg Mirikizumab (Reference): Thigh | 200 mg Mirikizumab (Test): Abdomen | 200 mg Mirikizumab (Test): Arm | 200 mg Mirikizumab (Test): Thigh |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 1 | 3 | 2 | 1 | 1 | 1 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
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 randomized participants.
| Characteristic | Unit | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|---|
| Participants analysed | 199 | 197 | 396 | |
| Age, Continuous | years | 40.7 (SD 13.0) | 41.1 (SD 12.2) | 40.9 (SD 12.6) |
| Sex: Female, Male: Female | Participants | 98 | 104 | 202 |
| Sex: Female, Male: Male | Participants | 101 | 93 | 194 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 36 | 33 | 69 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 163 | 164 | 327 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 11 | 6 | 17 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 29 | 30 | 59 |
| Race (NIH/OMB): White | Participants | 150 | 152 | 302 |
| Race (NIH/OMB): More than one race | Participants | 9 | 9 | 18 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 199 | 197 | 396 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab, measured over Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | micrograms per milliliter (μg/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the maximum concentration, Cmax, of mirikizumab, measured in micrograms per milliliter. Cmax represents the highest measured drug concentration in blood over the pharmacokinetic sampling period. It is one way to describe how much drug reaches the bloodstream after administration; it does not by itself describe the entire concentration-time profile or the time taken for the body to eliminate the drug.
The registry lists geometric means and geometric coefficients of variation for the two formulation groups. A geometric mean is used for data analyzed on a multiplicative scale, as is common for pharmacokinetic measures that may be skewed. The coefficient of variation describes relative variability around the group summary, rather than the spread in the original measurement units. For the reference formulation, the posted geometric mean was 13.0 μg/mL and the geometric coefficient of variation was 42, based on 196 participants. For the test formulation, the corresponding values were 12.9 μg/mL and 40, based on 192 participants.
Cmax is relevant to comparing exposure after the two formulations, but it is only one endpoint. The registry record describes a broader interest in the amount entering the bloodstream and the time required for elimination, while the posted primary result specifically addresses Cmax. The registry record does not report a complete set of pharmacokinetic results in the material, nor does it state the clinical or regulatory equivalence bounds used for the primary comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted Cmax summaries are close in numerical value: the reference group geometric mean was 13.0 μg/mL and the test group geometric mean was 12.9 μg/mL. These are descriptive summaries for the respective pharmacokinetic analysis groups, not the primary comparative estimate. The registry reports the comparison as a ratio of geometric least-squares means of 0.986, with a 90% confidence interval from 0.929 to 1.05. The interval describes uncertainty in the estimated ratio under the analysis used. It is not a range containing a known proportion of individual participants’ concentrations.
For a ratio, a value of 1 represents equal estimated geometric least-squares means. The point estimate of 0.986 is close to that reference value. The confidence interval extends from below 1 to above 1, so the reported interval includes the equal-ratio value. Whether the interval satisfies a formal bioequivalence criterion depends on prespecified acceptance limits. Those limits are not reported in the registry record. Therefore, the posted ratio and interval should be read as the reported estimate and its precision, not as a stand-alone declaration that a formal equivalence criterion was met or not met.
The arm-level geometric coefficients of variation, 42 for the reference formulation and 40 for the test formulation, indicate that variability is substantial relative to the geometric means. A coefficient of variation is a relative measure; it is not an absolute range and does not show how each participant’s concentration compared with another participant’s. The group sample sizes associated with the primary summaries are 196 and 192. Those counts describe the analysis groups, not necessarily everyone enrolled or randomized.
The registry record does not report a p-value for the comparison, and a p-value is not needed to interpret the confidence interval as an estimate with uncertainty. Nor does the record provide an equivalence margin, a detailed analysis method, or a narrative conclusion from the sponsor. As a result, the most defensible reading is limited to the posted numerical comparison: the estimated ratio is 0.986, and the 90% confidence interval ranges from 0.929 to 1.05. This does not answer every question about pharmacokinetics, safety, or equivalence.
The primary endpoint is a measured pharmacokinetic outcome in healthy participants. It should not be interpreted as a clinical benefit or as evidence about treatment effects in people with a disease. The record also does not report comparative results for every pharmacokinetic characteristic described in the study summary. Interpretation should remain specific to Cmax and the population included in its analysis.
9. Statistical Methods Explained
The primary result is expressed as a ratio of geometric least-squares means. This type of comparison is suited to outcomes analyzed on a multiplicative scale. A ratio conveys relative rather than absolute separation: a ratio of 1 corresponds to equal estimated group values, while values on either side represent estimates below or above that reference. The posted ratio is 0.986.
What does the confidence interval express?
The reported 90% confidence interval runs from 0.929 to 1.05. In general, a confidence interval communicates the precision of an estimate under the statistical model and analysis used. A narrower interval indicates greater precision than a wider interval, all else equal. It does not describe the range of individual participant measurements, and it does not mean that there is a 90% probability that the true value lies in this particular calculated interval. The registry record does not describe the model details used to construct this interval.
For a bioequivalence question, an interval is commonly evaluated against prespecified acceptance bounds. The bounds determine how close the estimated relative exposure must be for the intended conclusion. The registry record does not report those bounds or the decision rule. Consequently, the interval can be described and compared with the ratio reference point, but it cannot be used from the registry information alone to confirm whether the trial met its formal equivalence criterion.
Why use geometric summaries?
Pharmacokinetic measures often behave multiplicatively: proportional differences can be more meaningful than differences on the raw measurement scale. A geometric mean summarizes values after accounting for this scale, and geometric least-squares means are model-based group estimates. General statistical practice often analyzes such outcomes after a logarithmic transformation and then expresses the comparison on the original scale as a ratio. The registry record does not report enough methodological detail to confirm the exact transformation, model, covariates, or estimation procedure used in this analysis.
The reported geometric coefficients of variation are 42 for the reference group and 40 for the test group. In general, a coefficient of variation expresses variability relative to the scale of the measurement. It is useful when comparing variation across groups with different means, but it does not give the minimum and maximum values or show the distribution of observations. It is also distinct from a confidence interval around a group comparison.
Why do variability and analysis population matter?
Greater variability can make a group comparison less precise, even when the group summaries are close. This is one reason pharmacokinetic studies report both central estimates and measures of spread. The analysis population also affects interpretation: the primary endpoint was evaluated among participants who received at least one dose and had evaluable pharmacokinetic data. The record lists exclusions related to device malfunction, receipt of only one of the two injections, and incorrect administration, but its exclusion description is incomplete. It does not fully explain the handling of missing concentration measurements or other deviations.
The posted Cmax counts are 196 for the reference formulation and 192 for the test formulation. These are not interchangeable with the registry enrollment total of 396. In general, participants may be enrolled but not contribute evaluable measurements to a particular analysis. The registry record does not explain the disposition of all participants or give enough detail to assess how excluded or unevaluable participants may affect the comparison.
What can a planning calculation tell the reader?
Sample-size calculations based on an observed effect are planning illustrations, not evidence that a completed trial had a particular probability of success. The registry record describes a general approach for such illustrations: a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of an observed effect. It does not report the resulting participant counts in the material. Those illustrations cannot be treated as the trial’s original sample-size justification, and the registry record does not report that justification.
More generally, power is a design property tied to a specified effect, variability, analysis, and decision rule. It cannot be inferred just by observing the final estimate or by comparing the enrolled count with a later planning illustration. The posted confidence interval is a more direct account of the uncertainty around the reported comparison, while the absent equivalence limits and protocol-level justification leave important design context unavailable.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Ratio of Geometric least squares mean 0.986 | 0.929 to 1.05 | not reported |
The registry reports the sponsor’s comparison as a ratio of geometric least-squares means of 0.986, with a 90% confidence interval from 0.929 to 1.05. This is the comparative result to use when describing the posted analysis. The arm-level geometric means are 13.0 μg/mL for the reference formulation and 12.9 μg/mL for the test formulation; they are descriptive group summaries and should not be substituted for the reported comparative estimate.
No separate recalculated comparative result is reported in the registry record. The record does not provide the inputs and method needed to reconstruct an independent ratio and interval from the arm summaries alone, and a recalculation should not be inferred from rounded summaries. The registry record does not report a p-value for this comparison. It also does not state the formal equivalence margin or include a sponsor narrative explaining how the result was judged against a prespecified criterion.
There is no reported discrepancy between a sponsor result and a recalculated result. Accordingly, there is no conflicting recalculation to prioritize. The interpretation remains focused on the sponsor-reported ratio and its confidence interval, with the important qualification that the registry record does not report the acceptance limits required to assess a formal bioequivalence decision.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and three analyses, but it does not report a multiplicity adjustment or explain how the analyses relate to one another in a testing hierarchy. The primary Cmax comparison is the only comparative result described in detail in the available record. A detailed statistical analysis plan, including whether any formal correction for multiple testing was intended, is not reported in the registry record. It is therefore not possible to determine from the posted information whether the confidence interval or any decision rule was adjusted for multiplicity.
The registry identifies the primary pharmacokinetic analysis population as participants who received at least one dose and had evaluable pharmacokinetic data. It also identifies circumstances for exclusion, including device malfunction and administration of only one of the two autoinjector doses. The description of one exclusion circumstance ends before it is complete. The registry record does not report a complete participant flow, the number excluded for each reason, or how missing pharmacokinetic measurements were handled.
In general, missingness can matter if participants without evaluable measurements differ systematically from those included. Excluding observations can also affect the population to which a result applies. These are general statistical concerns, not evidence that a particular bias occurred in this trial. The available record does not provide enough detail to assess the direction or size of any effect from missing data or exclusions.
The registry record does not report the full statistical analysis plan, interim analyses, or a sample-size justification. It also does not describe the analysis populations for the other outcomes in enough detail to evaluate whether they used the same inclusion rules. The enrollment count is 396, while the Cmax analysis reports 196 participants in the reference group and 192 in the test group. The record does not account for all participants between enrollment and those analysis counts. These limitations do not change the numerical Cmax result, but they constrain assessment of how it was produced and how broadly it should be interpreted.
12. 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 |
|---|---|---|---|
| 200 mg Mirikizumab (Reference): Abdomen | 0 | 63 | 0.0% |
| 200 mg Mirikizumab (Reference): Arm | 0 | 69 | 0.0% |
| 200 mg Mirikizumab (Reference): Thigh | 0 | 67 | 0.0% |
| 200 mg Mirikizumab (Test): Abdomen | 0 | 66 | 0.0% |
| 200 mg Mirikizumab (Test): Arm | 0 | 66 | 0.0% |
| 200 mg Mirikizumab (Test): Thigh | 0 | 65 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 200 mg Mirikizumab (Reference): Abdomen | 0 of 63 |
| 200 mg Mirikizumab (Reference): Arm | 0 of 69 |
| 200 mg Mirikizumab (Reference): Thigh | 0 of 67 |
| 200 mg Mirikizumab (Test): Abdomen | 0 of 66 |
| 200 mg Mirikizumab (Test): Arm | 0 of 66 |
| 200 mg Mirikizumab (Test): Thigh | 0 of 65 |
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 |
|---|---|
| 200 mg Mirikizumab (Reference): Abdomen | 11 of 63 |
| 200 mg Mirikizumab (Reference): Arm | 12 of 69 |
| 200 mg Mirikizumab (Reference): Thigh | 13 of 67 |
| 200 mg Mirikizumab (Test): Abdomen | 7 of 66 |
| 200 mg Mirikizumab (Test): Arm | 11 of 66 |
| 200 mg Mirikizumab (Test): Thigh | 12 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 200 mg Mirikizumab (Reference): Abdomen | 200 mg Mirikizumab (Reference): Arm | 200 mg Mirikizumab (Reference): Thigh | 200 mg Mirikizumab (Test): Abdomen | 200 mg Mirikizumab (Test): Arm | 200 mg Mirikizumab (Test): Thigh |
|---|---|---|---|---|---|---|---|
| Injection site reaction | General disorders | 10 of 63 | 10 of 69 | 12 of 67 | 4 of 66 | 6 of 66 | 9 of 65 |
| Headache | Nervous system disorders | 2 of 63 | 4 of 69 | 2 of 67 | 3 of 66 | 7 of 66 | 3 of 65 |
The registry reports serious adverse effects for participants grouped by formulation and injection site. The listed at-risk counts range from 63 to 69 across the six site-by-formulation groups, and the serious adverse effect count is 0 in every listed group. Deaths are also recorded as 0 in each group. No serious adverse effect terms are listed in the record.
For other adverse effects, the counts are 11 for reference formulation in the abdomen group, 12 for reference in the arm group, and 13 for reference in the thigh group. For the test formulation, the corresponding counts are 7 for abdomen, 11 for arm, and 12 for thigh. Each group’s at-risk count is also reported. These figures are organized by injection site as well as formulation; they should not be collapsed into an overall comparison without knowing whether participants could be represented in more than one site group and how the record defines the counts.
Zero recorded serious adverse effects means none were reported in these listed groups; it does not establish that serious effects are impossible or that the formulations have identical safety profiles. The registry record does not provide event descriptions for the other adverse effects in this summary, nor does it give a statistical comparison for safety. These results describe the posted safety counts and should not be read as a treatment recommendation.
13. What the Result Does, and Does Not, Mean
The results describe a pharmacokinetic comparison of two mirikizumab formulations administered by autoinjector to healthy participants. For Cmax, the posted geometric means were 13.0 μg/mL for the reference formulation and 12.9 μg/mL for the test formulation. The sponsor-reported ratio of geometric least-squares means was 0.986, with a 90% confidence interval from 0.929 to 1.05. These figures summarize the estimated relative maximum concentration and the uncertainty reported around that estimate.
They do not establish a formal bioequivalence conclusion on their own. Such a conclusion depends on prespecified acceptance limits and the analysis plan, neither of which is reported in the registry record. The interval includes a ratio of 1, but that fact alone is not a substitute for evaluating the interval against the relevant limits. Nor does the estimate show that the formulations are identical for every participant or for every pharmacokinetic characteristic.
The result is specific to Cmax and to the analysis population with evaluable pharmacokinetic data. It is not, by itself, a comparison of clinical outcomes, long-term effects, or the full time course of drug concentration. The study summary describes interest in elimination as well as the amount entering the bloodstream, but a comparative result for elimination is not included in the primary result. The record also does not support conclusions about people with a medical condition because the listed population was healthy participants.
The safety figures show zero serious adverse effects and zero deaths in each listed site-by-formulation group, alongside reported counts of other adverse effects. These counts do not prove absence of risk, and the record does not provide enough detail to interpret the nature of the other effects or make a formal comparative safety assessment. Overall, the posted data support a narrow description of the Cmax estimate, its interval, the analysis group counts, and the reported safety counts. They do not supply all protocol and decision-rule information needed for broader conclusions.
14. Why This Trial Matters Statistically
Bioequivalence studies ask whether different formulations or delivery approaches produce sufficiently similar drug exposure under the study conditions. Statistical interpretation depends not just on how close two point estimates appear, but also on the precision of the comparison and the acceptance limits set for the intended decision. This record illustrates that distinction: the estimated ratio is 0.986 and its 90% confidence interval ranges from 0.929 to 1.05, while the registry record does not report the formal equivalence bounds.
The study also illustrates why endpoint-level reporting matters. The brief summary refers both to how much mirikizumab enters the bloodstream and how long the body takes to eliminate it. The posted primary outcome is specifically Cmax. Readers should distinguish this maximum concentration measure from other pharmacokinetic properties rather than treating one endpoint as a complete account of exposure.
Analysis populations are another important part of interpretation. The registry lists 396 enrolled participants, while the Cmax summaries are based on groups of 196 and 192. Eligibility for the pharmacokinetic analysis depended on receiving study drug and having evaluable data, with certain administration problems listed as exclusions. Without complete participant accounting and details about missing measurements, readers cannot fully assess the relationship between enrollment and the analyzed sample.
Finally, the safety results are grouped by both treatment formulation and injection site. That presentation matters because group counts and at-risk counts vary, and a simple overall comparison cannot be reconstructed without knowing how the groups were formed and whether observations overlap. Careful reading keeps the statistical claim aligned with what the registry actually reports: a particular pharmacokinetic estimate, an uncertainty interval, and descriptive safety counts, rather than a broad claim about clinical outcomes or all aspects of safety.
15. 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 registry record leaves important design and analysis details unavailable. It does not report the equivalence margins, the detailed statistical model, the method used to calculate the confidence interval, or a full statistical analysis plan. The record also does not report the sponsor’s sample-size justification. Without these details, the comparative estimate can be described, but the formal decision process cannot be independently assessed from the registry record.
The primary pharmacokinetic analysis is restricted to participants with at least one dose and evaluable data. The listed exclusion description is incomplete, and the record does not give a full accounting of participants who were enrolled, randomized, treated, excluded, or missing outcome measurements. The analysis counts are 196 for reference and 192 for test, compared with total enrollment of 396; the registry record does not explain the participant flow that connects these figures.
The endpoint reported in detail is Cmax. Although the study purpose also refers to drug elimination, a detailed comparative result for that question is not reported in the primary result. The record lists three outcomes and three analyses, but does not provide enough detail to assess their relationship, the analysis populations for each, or any adjustment for multiple comparisons.
The study was conducted in healthy participants, so the posted findings are not a direct estimate of outcomes in a patient population. The safety information is grouped by injection site and formulation, but the record does not describe the other adverse effects in this summary or provide a comparative safety analysis. The absence of reported serious events in the listed groups should not be interpreted as proof of no risk. These limitations define the scope of interpretation rather than invalidate the posted estimates.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants — NCT05515601.
- Registry record last updated 2024-07-05; status last verified 2024-01.
- Results first posted 2024-07-05.
- 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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19. Record Summary
The registry record describes a completed Phase 1 randomized, single-masked, parallel-group study of reference and test mirikizumab formulations administered subcutaneously by investigational 1-mL autoinjector to healthy participants. Total enrollment was 396. The primary endpoint was Cmax, measured in micrograms per milliliter over sampling visits from predose on Day 1 through Day 85 postdose.
The reference group had a geometric mean Cmax of 13.0 μg/mL and a geometric coefficient of variation of 42, based on 196 participants. The test group had a geometric mean of 12.9 μg/mL and a coefficient of variation of 40, based on 192 participants. The reported ratio of geometric least-squares means was 0.986, with a 90% confidence interval from 0.929 to 1.05. The registry record does not report the equivalence margins needed to assess a formal bioequivalence decision.
Serious adverse effect counts and deaths were recorded as 0 in all listed formulation-by-site groups. Other adverse effect counts varied across those groups. The record does not report enough detail to make broader conclusions about comparative safety, other pharmacokinetic outcomes, or clinical effects.