A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus (NCT05086445), a randomized phase 1 study. The primary outcome is Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

2. Clinical Question

The study’s stated main purpose was to learn about side effects of LY3502970 in Japanese participants with type 2 diabetes. Blood tests were also intended to examine how the body processes the drug and how the drug affects the body. The registry lists pharmacokinetic outcomes, including maximum concentration and area under the concentration-versus-time curve, as well as changes in fasting glucose, glycated hemoglobin, and body weight.

The primary question is about safety events, not whether LY3502970 improves diabetes outcomes. The registry record does not provide a single treatment-versus-placebo estimate for the primary endpoint. It also does not report values for the listed pharmacokinetic and metabolic outcomes in the information. Those results should therefore not be inferred from the study’s purpose or design.

3. Trial Design

This was a phase 1 randomized, double-masked, parallel study, with an enrollment of 62. The registry marks the study as completed. It began on 2021-11-12, and primary completion was 2022-09-05. The record identifies Japanese participants with type 2 diabetes mellitus as the population of interest.

The study had two parts. In Part A, participants received single oral doses of LY3502970 or oral placebo. In Part B, participants received multiple oral doses of LY3502970 or oral placebo. The Part B arm descriptions include different dose sequences, including groups labelled 2(or 3)/3/6/12 mg, 2/3/6/8/12/24 mg, and 2(or 3)/3/6/12/24/36/45 mg LY3502970 QD. The record does not describe the rationale for these sequences or provide a single pooled dose comparison.

For each participant, the study was planned to last up to 24 weeks, including screening, and involved 10 study-center visits. The primary safety endpoint timeframe was baseline through follow-up, up to Week 15. These timeframes describe different features of the study and should not be treated as interchangeable.

Randomized allocation and double masking are stated in the record, but the randomization procedure, allocation ratio, and details of who was masked are not reported in the registry record. The record also does not report a sample-size justification. Its enrollment count describes the study overall; it does not by itself establish the number of participants in each dose group or support a precise comparison between every group.

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.

Only the first 6 of 12 groups are shown.

Part A

Reasons for not completing this period:

Part B

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants from Part A and Part B who received at least one dose of study drug. For Part B, as specified in the statistical analysis plan, analyses were performed for the pre-specified treatment groups: placebo, 2(or 3)/3/6/12 mg LY3502970, 2/3/6/8/12/24 mg LY3502970, and 2(or 3)/6/12/24/36/45 mg LY3502970.

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 participants who were enrolled in Part A, Part B. A total of 62 participants were enrolled in the trial. Part A consisted of 23 participants of which 21 completed. Part B consisted of 60 participants inclusive of the 21 completers from Part A as per the Protocol.

Only the first 6 of 10 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, measured over Baseline Through Follow-Up (Up To Week 15).

The primary endpoint counts participants who had one or more treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) that the investigator considered related to study drug administration. The measurement is a count of people meeting the endpoint, rather than a count of every event. A participant with more than one qualifying event would still contribute as a participant with one or more events.

The registry defines a TEAE as an untoward medical occurrence that emerges during a defined treatment period after being absent before treatment, or that worsens relative to the pretreatment state. A TEAE does not necessarily have a causal relationship with treatment. An SAE is defined by specified serious consequences, including death, inpatient hospitalization, a life-threatening experience, persistent or significant disability, congenital anomaly or birth defect, and certain important medical events that may require intervention. The primary endpoint further limits the events of interest to those the investigator considered related to study drug administration.

Counting participants with at least one qualifying event is a way to summarize how many people experienced a safety event during the stated observation period. It does not describe the number, duration, severity, or timing of all events. The registry also says that an overall summary of SAEs and other non-serious adverse events, regardless of causality, is reported in the adverse-events module. That broader summary is not the same measure as the related-event primary endpoint.

The primary endpoint results are not reported in the registry record in a form that supports one summary comparison. The posted group safety figures should therefore be read as descriptive information, not substituted for the endpoint’s investigator-related event definition.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the design as randomized, double-masked, and parallel. These are design labels, not a complete statistical analysis plan. The record does not report the randomization method, allocation ratio, analysis model, handling of repeated measurements, or procedures for adjusting comparisons. The descriptions below explain general statistical concepts and do not assert that a particular unreported method was used in this study.

What does a participant-count endpoint represent?

In general, a binary participant-level safety endpoint classifies each person according to whether they did or did not meet a specified event definition during a specified period. A count of participants with at least one event answers a different question from a count of all events. The participant count is not increased each time the same person experiences another event. For this trial, the primary endpoint is defined by at least one qualifying TEAE or SAE considered related to study drug administration, over baseline through follow-up up to Week 15.

The definition matters. TEAEs are events emerging during the defined treatment period or worsening from the pretreatment state; the registry notes that they do not necessarily have a causal relationship to treatment. The primary endpoint adds the investigator’s assessment of relatedness. An all-causality adverse-event summary therefore has a broader scope than the primary endpoint. The summary counts should not be treated as interchangeable unless the event definition and attribution criteria match.

Why are the study groups important?

In general, randomization is intended to assign participants to groups by chance, while masking is intended to limit knowledge of treatment assignment during study conduct. These design features can help reduce certain sources of bias, but they do not remove uncertainty or guarantee that every comparison is informative. The registry reports that this study was randomized and double-masked, but does not describe the procedures in enough detail to assess their implementation.

The parallel design means the record describes different treatment groups rather than a crossover comparison in which each participant receives multiple assigned treatments in sequence. Here, Part A and Part B differ in whether dosing was single or multiple, and the listed LY3502970 arms have distinct dose sequences. A comparison should therefore identify which groups and time period it concerns. A pooled comparison across parts or dose sequences should not be assumed without a reported analysis plan.

How should uncertainty be assessed?

In general, an effect estimate summarizes the observed contrast between groups, while a confidence interval describes the uncertainty around that estimate under the chosen statistical model. A narrow interval indicates greater precision than a wide interval, but neither the interval nor the estimate alone determines clinical importance. A p-value, when used, summarizes how compatible the data are with a specified null model; it does not measure the probability that a treatment works or that the null hypothesis is true.

No primary endpoint effect estimate, confidence interval, or p-value for a single treatment-versus-placebo comparison is reported in the registry record. The posted outcome has several categories or time points and is not reduced to one comparison. The statistical model and inferential procedure are also not reported. It is therefore not possible to explain a trial-specific p-value or interval, or to characterize a treatment contrast as statistically significant or not significant.

What do the safety counts leave out?

In general, a count of participants with events does not convey the event’s severity, duration, recurrence, or clinical course. A participant-level count also does not reveal the number of total events. The registry defines SAEs by specified serious consequences and separately identifies investigator-related events for the primary endpoint. The serious-event group counts are useful descriptive information, but the endpoint-specific related-event results are not reported in a way that allows a full group-by-group interpretation.

For uncommon outcomes, the absence of observed events in a group does not show that the underlying event risk is zero. The amount of uncertainty depends in part on the number observed and the number of participants followed, as well as on the analysis and observation period. These general considerations are especially relevant when reading small early-phase studies, but the registry record does not provide an interval estimate for the serious-event counts.

What can planning calculations say?

In general, sample-size calculations estimate how many participants may be needed to detect a specified effect under stated assumptions. The record describes planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. Such calculations are hypothetical planning illustrations, not observed power and not trial outcomes. The sample-size justification used to design this study is not reported in the registry record. The multiple groups and the absence of one reduced primary comparison also limit how directly a two-arm illustration can represent this study.

More generally, statistical interpretation depends on the endpoint definition, analysis population, follow-up, and handling of missing observations. The registry identifies the primary endpoint population as participants in Parts A and B who received at least one dose. It gives specific Part B treatment groups for analysis, but does not report the full analysis procedures. The methods cannot be reconstructed from the design labels and outcome definitions alone.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 8 outcome measures and 9 analyses. The outcomes span safety, pharmacokinetics, and changes in fasting glucose, glycated hemoglobin, and body weight. When several outcomes, groups, time points, or dose comparisons are examined, the chance of finding an apparently notable result by chance can increase. In general, a prespecified multiplicity strategy may define which comparisons are confirmatory and how inference is adjusted. Such a strategy is not reported in the registry record.

The primary outcome is described as having several categories or time points and is not reduced to one comparison in the posted analysis. The record does not specify which pairwise comparisons, if any, were intended to be primary, how dose groups were to be compared, or how any multiplicity was handled. A single overall statistical conclusion should not be inferred from the listed outcomes.

The primary endpoint population includes participants from Parts A and B who received at least one dose. For Part B, the record identifies prespecified treatment groups for analysis. The detailed analysis populations for the secondary outcomes, including whether they differ by outcome, are not reported in the registry record.

Missing-data methods are also not reported in the registry record. The record does not describe how missing measurements, withdrawals, or incomplete follow-up were handled in the outcome analyses. This matters because the amount and pattern of missing data can affect the interpretation of estimates, particularly for outcomes measured over time. No imputation or sensitivity analysis should be assumed.

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 posted group safety figures show zero participants affected by serious adverse events in each listed group. They also report deaths as zero in each group. These are descriptive counts for the study groups; they do not establish that the underlying risk of a serious event is zero.

The same figures include counts of participants with other adverse events. Those counts are part of the broader safety summary and are not, by themselves, the primary endpoint result. The primary endpoint requires a TEAE or SAE considered by the investigator to be related to study drug administration. The overall adverse-event summary includes events regardless of causality, so its counts do not necessarily match that endpoint definition.

The serious-event counts should be interpreted alongside the number of participants at risk in each group and the study’s follow-up period. In general, a zero count in a group means no such event was observed in the posted data for that group; it cannot rule out an event occurring in a larger population or over a different observation period. The registry does not provide an interval estimate for these counts or enough endpoint-specific detail to determine related-event rates by group. The figures are safety descriptions, not a standalone comparison of treatment effects.

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

The posted information supports a limited description of the study: it was a randomized, double-masked, parallel phase 1 study in Japanese participants with type 2 diabetes, with single-dose and multiple-dose parts and oral placebo groups. The group safety figures list no participants affected by serious adverse events and no deaths. Those observations describe what was recorded in this study’s groups over the relevant observation period.

They do not establish that serious adverse events cannot occur, that the risk is zero, or that one treatment group is safer than another. The study includes multiple groups and dose sequences, and the registry does not report a single adjusted comparison with an effect estimate and uncertainty interval. The primary endpoint’s focus on investigator-related events also differs from the broader all-causality adverse-event summary.

The study’s stated purpose and listed secondary outcomes do not substitute for reported outcome values. The record identifies pharmacokinetic measures and changes in fasting glucose, glycated hemoglobin, and body weight, but the results for those measures are not reported in the registry record. No conclusion about those outcomes follows from the safety counts.

More broadly, a phase 1 study can describe safety and drug-related measurements in its enrolled participants, but the registry entries do not support a claim about treatment effectiveness or about outcomes beyond the observed groups and follow-up. The sample-size information and design labels also do not supply missing estimates or statistical tests. The appropriate reading is therefore descriptive: note what the registry reports, distinguish related from all-causality events, and recognize that the comparative and outcome-specific evidence is not reported in sufficient detail for stronger conclusions.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its primary question concerns safety across a study with more than one dosing pattern and several treatment groups. Part A examines single oral doses, whereas Part B examines multiple oral doses with several dose-sequence labels. That structure makes the choice of comparison important: the study cannot be summarized adequately by assuming one pooled LY3502970 group and one placebo group.

The endpoint also illustrates why outcome definitions matter. The primary endpoint counts participants with at least one TEAE or SAE considered related by the investigator, while the broader adverse-event summary includes events regardless of causality. These are distinct estimands: they describe different event sets and answer different questions. Reading one as if it were the other could overstate what the posted counts establish.

The record further shows the difference between a study’s design and its reported analysis. Randomization and masking are design features, but they do not provide an effect estimate, confidence interval, or p-value. The registry lists multiple outcome measures and analyses, yet does not report a single primary comparison or the methods for handling multiplicity and missing data. Those omissions make the posted counts more useful for descriptive context than for comparative inference.

Finally, the zero serious-event counts show why precision matters in safety reporting. A zero in observed data is a factual count, not proof of no underlying risk. Confidence intervals or other uncertainty summaries would help characterize what the data can support, but they are not reported. The study therefore offers a useful example of how to separate observed safety counts, endpoint definitions, and conclusions that require more complete statistical results.

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 registry record does not report the primary endpoint results as a single comparison, and its skip information indicates that the outcome has several categories or time points. The posted group-level safety figures do not provide the endpoint-specific counts of investigator-related TEAEs and SAEs needed to interpret that primary measure fully. They should not be treated as though they answer a single treatment-versus-placebo question.

There are multiple dose groups across Parts A and B, and the record does not provide a pooled comparison or enough statistical detail to assess how groups were compared. It does not report effect estimates, confidence intervals, p-values, or an analysis model for the primary endpoint. The randomization procedure and allocation ratio are also not reported in the registry record.

The registry lists pharmacokinetic and metabolic outcomes, but the outcome values and comparative results are not reported. Multiplicity procedures, missing-data handling, and the detailed analysis populations for secondary outcomes are not reported in the registry record. The sample-size justification used for the study is also not reported, so planning illustrations should not be mistaken for evidence about the study’s actual precision or power.

Finally, the study was conducted in Japanese participants with type 2 diabetes, and the record describes follow-up up to Week 15 for the primary safety endpoint. The posted information does not establish how findings would apply to other populations or longer observation periods. These limitations restrict interpretation to the descriptive information available for this study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus — NCT05086445.
• Registry record last updated 2026-07-16; status last verified 2026-06-01.
• Results first posted 2026-07-16.
• 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

This completed phase 1 study enrolled 62 Japanese participants with type 2 diabetes mellitus. It was randomized, double-masked, and parallel, with oral single-dose LY3502970 and placebo groups in Part A and oral multiple-dose LY3502970 and placebo groups in Part B. Each participant’s study duration was up to 24 weeks, including screening, with 10 study-center visits.

The primary endpoint counted participants with one or more investigator-related TEAEs and SAEs from baseline through follow-up up to Week 15. The posted group safety figures list zero participants affected by serious adverse events and zero deaths in each group. These descriptive counts do not provide a single comparison for the primary endpoint. The registry also lists pharmacokinetic, fasting-glucose, glycated-hemoglobin, and body-weight outcomes, but their results are not reported in the registry record.