A Study of LY3502970 in Participants With Impaired and Normal Liver Function: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of LY3502970 in Participants With Impaired and Normal Liver Function (NCT05882032), a non-randomized phase 1 study. The primary outcome is Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970.

2. Clinical Question

This is a pharmacokinetic question: it concerns the concentration of drug in the bloodstream over time, rather than a clinical outcome. The study collected concentration measurements before dosing and at scheduled times after the Day 1 dose, through 96 hours post-dose. AUC from time zero to infinity is intended to summarize exposure across the measured period and the estimated portion extending beyond it. The record also identifies evaluation of safety and tolerability as a study purpose, but it does not report a clinical benefit question.

The groups represent different hepatic-function categories, not randomized treatment assignments. Each category received the same dose, so the intended comparison concerns pharmacokinetics across those categories. Differences between groups could reflect factors other than hepatic function; the registry record does not describe adjustment for such factors. It also does not report a prespecified contrast, an effect estimate, or uncertainty intervals for the comparison. Consequently, the registry record states the question the study was designed to address but does not establish the size or precision of any observed difference.

3. Trial Design

The registry describes a Phase 1, multicenter, parallel, single-dose, open-label, single-period study. Its allocation is listed as nonrandomized, and masking is listed as none. The record reports enrollment of 29 and a status of completed. The study start date is 2023-06-13, and the primary completion date is 2024-11-18. Participants were grouped by hepatic function: normal, mild impairment, moderate impairment, or severe impairment. The group descriptions state that each received a single oral 1 mg dose of LY3502970 on Day 1.

In a parallel design, participants in different groups are assessed in their respective groups rather than crossing through each study condition. Here, the key grouping characteristic was hepatic function. Because the study was nonrandomized, the registry record does not support treating the normal-function group as a randomized control group. The record does not explain how participants were allocated to hepatic-function categories, nor does it describe matching or statistical adjustment between groups. Those details are not reported in the registry record.

The stated study purpose was to measure how much LY3502970 enters the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function compared with normal hepatic function. Safety and tolerability were also to be evaluated. The summary says the study may last up to 6 weeks for each participant, including screening. Pharmacokinetic samples were scheduled from pre-dose through 96 hours post-dose on Day 1. The registry record does not report the full visit schedule or procedures beyond those details.

The record lists three outcome measures, identifies the AUC endpoint as primary, and contains no analysis entries. It does not report a trial-specific sample-size justification, a detailed statistical analysis plan, or planned covariates. The enrollment figure describes the study record; it should not be read as the number contributing evaluable data to the primary endpoint, because the endpoint population was restricted to participants with evaluable pharmacokinetic data.

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

Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).

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.

6. Primary Endpoint

The registry lists the primary outcome as Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970, measured over Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1.

The primary endpoint is the area under the LY3502970 concentration-versus-time curve from time zero to infinity, abbreviated AUC (0-∞), with units of nanogram *hour per milliliter (ng*h/mL). Concentration measurements were scheduled pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1. AUC combines concentration and time into a measure of overall drug exposure. Extending the interval to infinity aims to include exposure after the last measured concentration, using an extrapolated portion of the curve.

As a general statistical concept, AUC is useful in pharmacokinetic studies because it condenses a sequence of concentration measurements into a summary of exposure. It does not, by itself, describe every feature of the concentration profile, such as the peak concentration or the time of that peak. The registry lists the endpoint summary as a geometric mean, with geometric coefficient of variation as its dispersion measure. These summaries are commonly used for positive measurements that may vary multiplicatively; the record does not provide the underlying values needed to assess their distribution in this study.

The primary endpoint population is described as enrolled participants who received at least one dose and had evaluable pharmacokinetic data. The record also describes an exclusion related to vomiting at or before 2 times the median time of maximum observed drug concentration, but the wording of that eligibility statement is incomplete. No AUC group estimates, geometric coefficients of variation, confidence intervals, or comparison results are reported in the registry record. Therefore, the endpoint definition is available, but the observed result cannot be interpreted from the registry entry.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the endpoint and its intended summary statistics, but does not report the inferential methods or any analysis results. The concepts below explain how such measures are generally interpreted; they should not be taken as confirmation that a particular model, test, or adjustment was used in this study.

What does AUC measure?

As a general concept, the area under a concentration-versus-time curve represents cumulative exposure over an interval. AUC (0-∞) includes the measured portion of the curve and an estimated tail extending beyond the last observed time. The estimated tail matters because drug may remain in the body after the last scheduled sample. The accuracy of the infinite-interval estimate depends in part on the observed concentrations and the method used to extrapolate the remaining curve. The registry record names AUC (0-∞) but does not report the calculation details, the proportion extrapolated, or any participant-level concentration profiles.

AUC is not interchangeable with peak concentration or time to peak. Those are distinct pharmacokinetic features. The record's primary endpoint concerns overall exposure; it does not report results for those features as primary outcomes. Scheduled samples ran from pre-dose through 96 hours post-dose on Day 1, but the record does not explain how observations below a quantification limit, incomplete profiles, or irregular sampling were handled.

Why report a geometric mean?

The registry identifies the geometric mean as the endpoint summary. In general, a geometric mean is formed by working on a logarithmic scale and then returning the summary to the original scale. This can be suitable for positive measurements where variation is better understood in multiplicative terms than as a fixed additive amount. For example, a multiplicative difference describes proportional scaling, whereas an additive difference describes a fixed change in the measurement units. This is a general explanation, not a claim that a specific distributional assumption was checked or satisfied in this study.

The geometric coefficient of variation is the listed dispersion measure. In general, a coefficient of variation expresses variability relative to the scale of the measurements, and its geometric form is associated with analysis on the log scale. It is not a confidence interval and does not directly show the uncertainty around a group mean. Since the registry record contains no numerical geometric means or coefficients of variation, it is not possible to assess either the exposure summaries or the spread of participant values.

What can a group comparison establish?

In general, a comparison estimates how a measured outcome differs between groups, while an uncertainty interval conveys the precision of that estimate under the chosen method. A p-value, if reported, addresses compatibility of data with a specified statistical null model; it does not measure the size or clinical importance of a difference. The registry record reports no comparison estimate, confidence interval, p-value, or analysis entry for the primary endpoint. It also does not report the hypothesis or contrast that would define such a test. No inferential conclusion should be inferred from the endpoint name or the study's completion status.

The parallel, nonrandomized design means the hepatic-function groups were not created by random assignment. As a general principle, randomization can balance measured and unmeasured factors in expectation, whereas a nonrandomized comparison may retain differences between groups. Descriptive group summaries can still characterize observed pharmacokinetics, but causal interpretation would require additional design or analytic support. The registry record does not report covariate adjustment, matching, or another method intended to address group differences.

How should precision be considered?

Precision is distinct from the direction or size of an estimated effect. In general, an interval estimate gives a range of values compatible with the data and statistical method, while a standard error quantifies sampling variability on the estimator's scale. Neither is reported for the primary endpoint in this record. The group sizes listed in adverse-event reporting do not establish how many participants contributed evaluable AUC data, so they cannot be used to infer the precision of the pharmacokinetic estimates.

The registry record reports enrollment of 29, but does not provide endpoint-specific counts or a sample-size justification. A planning calculation based on an observed effect, when available, is a design illustration rather than observed power. Power is a property of a specified design and assumed effect for planning; it is not a measure of whether an observed result is reliable. No trial-specific power or sample-size rationale is reported in the registry record. In the absence of numerical endpoint results and uncertainty measures, interpretation must remain focused on the design and the outcome definition rather than the size or precision of a group difference.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies AUC (0-∞) as the primary endpoint and lists three outcome measures overall. It does not report a multiplicity strategy, a hierarchy among the other outcomes, or a family of hypotheses to be tested. Multiplicity is a general statistical issue that arises when several outcomes or comparisons are tested: without an appropriate plan, the chance of at least one apparently unusual result can increase. The registry record does not state whether any adjustment was intended, so no such procedure should be assumed.

The primary endpoint population is described as all enrolled participants who received at least one dose and had evaluable pharmacokinetic data for that outcome. It also describes exclusion in the case of vomiting at or before 2 times the median time of maximum observed drug concentration. The registry wording ends partway through that exclusion description; further details are not reported in the registry record. The record does not give the number of participants included in the primary endpoint analysis or explain how participants without evaluable data were handled.

Missing-data methods are not reported in the registry record. It does not explain whether missing concentrations were imputed, whether incomplete sampling profiles could contribute to AUC, or how any other missing outcome information was treated. The record also does not report sensitivity analyses for missing data or exclusions. Such details matter because the endpoint population may differ from the full enrolled population, and the nature of missingness can affect interpretation. The described analysis population should therefore be distinguished from enrollment, without assuming that every enrolled participant contributed to the primary endpoint.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events separately from other adverse events. In the normal hepatic-function group, serious adverse events affected 0 among 11 at risk, and other adverse events affected 2 among 11 at risk. In the mild hepatic-impairment group, serious adverse events affected 0 among 6 at risk, and other adverse events affected 1 among 6 at risk. In the moderate hepatic-impairment group, serious adverse events affected 0 among 6 at risk, and other adverse events affected 1 among 6 at risk. In the severe hepatic-impairment group, serious adverse events affected 0 among 6 at risk, and other adverse events affected 0 among 6 at risk. Deaths are reported as 0 in every group.

These are descriptive counts from the registry record. A serious adverse event is a category distinct from the other adverse-event count; a zero serious-event count does not mean that no other adverse events occurred. The counts alone do not show when events occurred, their severity apart from the serious classification, their relationship to LY3502970, or whether they were experienced by the same participants as another event. Those details are not reported in the registry record.

Because the study was nonrandomized and the groups differ in size, the counts should not be read as a controlled estimate of comparative risk. The record does not provide a statistical safety comparison or uncertainty intervals. These figures describe what the registry records in each group, not evidence that a treatment is safe or unsafe.

12. What the Result Does, and Does Not, Mean

The registry record documents a Phase 1 study intended to characterize LY3502970 exposure after a single oral dose across groups defined by hepatic function. It gives the primary endpoint definition, measurement schedule, and summary-statistic labels. It also reports adverse-event counts. These details establish what the study set out to examine and some of the observed safety reporting, but they do not supply the numerical pharmacokinetic outcome.

The record does not report group AUC estimates, a comparison of impairment categories with normal hepatic function, confidence intervals, or p-values. Therefore, it is not possible to state from this entry whether exposure was higher, lower, or similar across the groups, or how precisely any such difference was estimated. A completed study status does not substitute for posted outcome values.

The design also limits what a comparison would mean. Participants were not randomized to hepatic-function categories, and no adjustment strategy is reported. A difference in group summaries, if numerical results were available, would be an association in this study rather than proof that impaired liver function caused the difference. Other characteristics that may vary across groups could also be relevant, but their role is not assessed in the registry information.

The safety entries are similarly limited. They record serious and other adverse events and deaths by group, but do not establish event causation or provide a comparative statistical assessment. The registry record does not report detailed event descriptions or a risk estimate with uncertainty.

In general, a pharmacokinetic study can provide information about measured exposure under the study conditions. It does not by itself establish clinical benefit, long-term outcomes, or how findings apply outside the enrolled groups and dose studied. Those broader questions are not answered by the available registry information. The most defensible reading is therefore that the study's question and methods are identifiable, while its primary numerical result and inferential interpretation are not reported in the registry record.

13. Why This Trial Matters Statistically

This study addresses a pharmacokinetic comparison across hepatic-function categories, with normal hepatic function as the reference group and mild, moderate, or severe impairment as the other categories. Such a design can be statistically informative because it focuses on exposure under a common single-dose regimen, while measuring concentrations over a scheduled period. The primary endpoint, AUC (0-∞), provides a summary of overall exposure rather than relying on a single concentration measurement.

Several statistical features matter for interpreting this question. The record identifies a geometric mean and geometric coefficient of variation, which are useful concepts for summarizing positive pharmacokinetic measures when multiplicative variation is relevant. It also identifies the endpoint population, requiring at least one dose and evaluable pharmacokinetic data. Both choices affect how the estimates should be understood: the summary scale describes the data, and the analysis population defines whose data contribute.

The nonrandomized design is also important. Participants were categorized by hepatic function rather than assigned to categories at random, so comparisons may reflect differences among the groups beyond hepatic function. Clear reporting of group estimates, uncertainty, analysis methods, and participant contributions would be needed to judge the magnitude and precision of any observed contrast. Those results and methods are not reported in the registry record.

The registry entry is useful for establishing the study structure, dose, sampling schedule, endpoint definition, and recorded adverse-event counts. Its limitations are equally important: without the primary estimates and analysis, the stated pharmacokinetic question cannot be answered from this record alone. The distinction between a well-defined measurement and a reported result is central to statistical reading of clinical-trial registries.

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 this study from the registry record is that the primary pharmacokinetic estimates are not reported. The record names AUC (0-∞), its units, summary form, and dispersion measure, but gives no group values or statistical comparisons. It therefore cannot show the direction or magnitude of any difference, or its precision.

The design is nonrandomized and open-label, with no masking. Participants were grouped by hepatic function, and the record does not report matching, adjustment, or methods for accounting for differences between groups. The normal-function group is consequently not a randomized control group. The registry record does not provide the enrollment criteria in detail or a detailed account of participant characteristics, so the comparability of groups cannot be assessed from the information available.

The primary analysis population is restricted to participants with a dose and evaluable pharmacokinetic data. The record does not report how many contributed to this endpoint, how incomplete concentration profiles were handled, or whether missing data were addressed through imputation or sensitivity analyses. Its vomiting-related exclusion statement is incomplete, and further operational details are not reported in the registry record.

The registry lists three outcome measures but no analysis entries. It does not describe the statistical analysis plan, planned contrasts, multiplicity handling, sample-size justification, or interim analyses. These items are not reported in the registry record and should not be presumed. The adverse-event counts are descriptive and lack detail on event timing, attribution, and comparative uncertainty.

Finally, the study concerns a single 1 mg oral dose, with pharmacokinetic sampling scheduled through 96 hours post-dose on Day 1. The registry summary says each participant's study may last up to 6 weeks including screening, but longer-term outcomes are not reported. Conclusions about other dosing conditions, long-term safety, or clinical outcomes are outside what this registry entry establishes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study of LY3502970 in Participants With Impaired and Normal Liver Function — NCT05882032.
• Registry record last updated 2026-05-27; status last verified 2026-04.
• Results first posted 2026-05-27.
• 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.

18. Record Summary

NCT05882032 is a completed Phase 1, multicenter, parallel, nonrandomized, open-label, single-period study of LY3502970 in participants with normal hepatic function or mild, moderate, or severe hepatic impairment. The registry reports enrollment of 29, a study start date of 2023-06-13, and a primary completion date of 2024-11-18. Each group received a single oral 1 mg dose on Day 1.

The primary endpoint was AUC (0-∞) of LY3502970, summarized as a geometric mean with geometric coefficient of variation. The record defines a pharmacokinetic analysis population but does not report endpoint estimates or statistical comparisons. It also reports serious adverse-event counts of 0 in each group, other adverse-event counts of 2, 1, 1, and 0 across the normal, mild, moderate, and severe groups, respectively, and 0 deaths in each group. These safety figures are descriptive; a comparative analysis is not reported in the registry record.