A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities (NCT06023095), 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 asked whether LY3502970 could be administered to Chinese participants with obesity or overweight accompanied by weight-related comorbidities, with safety and tolerability as the main focus. It also examined how the body processes the drug and how the drug affects the body, using blood tests and pharmacodynamic measures. The registry record describes randomized, double-masked, parallel assignment to LY3502970 or placebo. LY3502970 was given orally once daily, with dose escalation in each active-treatment cohort.

The secondary objectives include pharmacokinetic measures of maximum observed concentration and area under the concentration-versus-time curve at steady state, assessed separately by cohort. Pharmacodynamic measures include changes from baseline in body mass index, body weight, waist circumference and fasting plasma glucose. Numerical results for these outcomes are not reported in the registry record, so the study question can be described, but the size or precision of any treatment-associated changes cannot be evaluated from the posted results.

3. Trial Design

This was a randomized, double-masked, parallel phase 1 study sponsored by Eli Lilly and Company. The registry record lists a total enrollment of 24 and a completed study status. The study began on 2023-09-21, and primary completion was recorded as 2024-07-29. The enrolled population comprised Chinese participants with obesity or overweight with weight-related comorbidities.

Participants received oral LY3502970 or oral placebo. The active-treatment regimen differed by cohort. In Cohort 1, dose escalation began at 1 mg and proceeded to 3 mg, 6 mg and 12 mg, administered once daily from Day 1 for 16 weeks. In Cohort 2, escalation began at 1 mg and proceeded to 3 mg, 6 mg, 12 mg, 24 mg and 36 mg, administered once daily from Day 1 for 24 weeks. The placebo description specifies oral once-daily administration but does not give a matching titration schedule.

The study description estimates that each participant's time in the study would be about approximately 22 weeks for Cohort 1 and 30 weeks for Cohort 2, including screening. The primary safety timeframe is baseline through Week 18 for Cohort 1 and Week 26 for Cohort 2. These differing cohort schedules matter when interpreting exposure and follow-up: participants in the two active-treatment cohorts did not follow the same dose-escalation sequence or treatment duration.

Randomization and double masking are recorded, but the method used to generate the allocation sequence, the allocation ratio, the masking procedures, and whether masking was maintained throughout are not reported in the registry record. The protocol's sample-size justification and any planned interim analyses are also not reported in the registry record. With a phase 1 study centered on safety, tolerability, pharmacokinetics and pharmacodynamics, the registry description does not establish that the study was designed to detect a confirmatory clinical effect.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All enrolled participants who receive at least 1 dose of study drug.

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 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 Week 18 (Cohort 1) & Week 26 (Cohort 2).

The primary endpoint is the number of participants with one or more treatment-emergent adverse events or serious adverse events that the investigator considered related to study drug administration. It is expressed as a participant count, rather than as a continuous measurement such as a laboratory value or a change in weight. The stated population includes all enrolled participants who receive at least 1 dose of study drug. Assessment runs from baseline through Week 18 in Cohort 1 and Week 26 in Cohort 2.

Safety endpoints of this kind are used to describe the occurrence of potentially important harms during exposure and follow-up. Counting participants with an event answers how many people were affected, rather than how many total episodes occurred. The endpoint's attribution requirement also matters: the primary definition focuses on events considered related to study drug by the investigator. That is a judgment about possible relationship, not proof that the drug caused an event.

The registry record says that a summary of treatment-emergent adverse events, serious adverse events and other non-serious adverse events, regardless of causality, will be reported in the adverse-events module. This broader reporting scope is not identical to the primary endpoint's investigator-related definition. The adverse-event counts posted for serious and other events therefore should not be treated as numerical results for the primary endpoint unless the record explicitly identifies them that way. Numerical results for the primary endpoint itself are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What randomization contributes. Randomization is intended to allocate participants to treatment groups using a chance-based process. In general, this can reduce systematic differences between groups at baseline, including differences that were not measured. It does not guarantee that groups will be similar in a small study, and it does not remove uncertainty from a comparison. The registry record identifies the study as randomized, but the sequence-generation method, allocation concealment procedures and allocation ratio are not reported in the registry record.

What double masking means. Masking is intended to limit the influence of treatment knowledge on participants' experience or reporting and on investigators' assessment. The registry record labels the study double-masked. It does not report which individuals were masked, how masking was implemented, or whether the success of masking was assessed. Those details cannot be inferred from the design label alone.

Parallel groups and dose escalation. A parallel design assigns participants to a group and follows that group through its assigned regimen, rather than having every participant receive each study treatment in turn. Here, active treatment involved different escalation schedules in the two cohorts: Cohort 1 reached 12 mg during its 16-week regimen, whereas Cohort 2 escalated through 36 mg during its 24-week regimen. Because the cohorts had different schedules and durations, their observations should not be treated as if they arose from an identical exposure plan. The placebo group is described as receiving oral placebo once daily.

Participant counts for safety outcomes. The primary endpoint is a count of participants with one or more events meeting its definition. A participant-level count records whether a participant experienced at least one qualifying event; it does not communicate the total number of episodes or their duration. For safety interpretation, it is also important to distinguish serious events from other events and to distinguish events considered related to treatment from those recorded regardless of causality. The posted group counts report serious and other adverse events, while the primary endpoint specifically concerns events considered related by the investigator. The record does not provide a numerical result for that primary definition.

Why event counts are uncertain. In general, an observed count is a description of the participants studied, not a guarantee of the event frequency in a wider population. When few participants are observed, the data may be compatible with a broad range of underlying event frequencies. A lack of observed serious events therefore does not demonstrate that the underlying risk is zero. Formal uncertainty intervals could help characterize the range compatible with the observed data, but such intervals for the posted safety counts are not reported in the registry record.

Pharmacokinetics and pharmacodynamics. Pharmacokinetics describes how drug concentration changes over time and is used to characterize exposure. The listed pharmacokinetic outcomes include maximum observed concentration and area under the concentration-versus-time curve from time 0 to 24 hours at steady state, separately for Cohort 1 and Cohort 2. Pharmacodynamics concerns the body's response to treatment. The listed pharmacodynamic outcomes are changes from baseline in body mass index, body weight, waist circumference and fasting plasma glucose. These are distinct outcome types: concentration measures describe exposure, while the listed body measurements and glucose measure describe responses. Their numerical estimates, variability and statistical comparisons are not reported in the registry record.

Confidence intervals and p-values. In general, a confidence interval expresses uncertainty around an estimated quantity; a narrower interval indicates greater precision under the method's assumptions. A p-value, when used, evaluates how compatible data are with a specified null model, rather than expressing the probability that a treatment works or that the null hypothesis is true. The registry record does not report confidence intervals or p-values for the primary or secondary outcomes. Without estimates and uncertainty measures, statistical precision and the strength of evidence for differences cannot be evaluated from the posted results.

Over-dispersion and count data. In general, count outcomes can vary more than a simple statistical model expects, a property called over-dispersion. If present, over-dispersion can make conventional uncertainty estimates too small unless the analysis accounts for it. The registry record does not report a model for adverse-event counts, any assessment of over-dispersion, or a method for estimating comparative effects. No particular model should therefore be attributed to this study based only on the posted record.

Sample size and power. In general, a sample-size calculation relies on assumptions about the outcome, the effect to detect, variability or event frequency, and the desired operating characteristics. It is a planning exercise, not evidence that an observed effect is precise. The registry record does not report the protocol's sample-size justification or its assumptions. No observed-power conclusion can be drawn from the enrollment count or the event counts.

Analysis populations and outcome handling. The stated primary endpoint population is all enrolled participants who received at least 1 dose. The record does not report how participants with missing assessments were handled, how deviations from assigned treatment were addressed, or whether separate analysis populations were used for pharmacokinetic and pharmacodynamic outcomes. It also lists no statistical analyses. These omissions limit assessment of whether the posted counts and any future outcome estimates reflect all randomized participants, all treated participants, or a subset defined by outcome availability.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes: pharmacokinetic measures for each active-treatment cohort and pharmacodynamic changes in body mass index, body weight, waist circumference and fasting plasma glucose. It also identifies a primary safety endpoint. When a study evaluates several outcomes, the chance of obtaining at least one apparently notable result can increase if each is tested independently. Statistical plans may address this multiplicity through outcome hierarchies, adjusted significance thresholds or other prespecified strategies. The registry record does not report a multiplicity strategy, and it lists no statistical analyses. It is therefore not possible to determine whether or how the study accounted for multiple outcome comparisons.

Missing-data methods are not reported in the registry record. The record does not explain how absent visits, unavailable blood samples, incomplete outcome measurements or early discontinuation were handled. It also does not report whether any imputation or sensitivity analyses were planned. Missingness can affect estimates when the probability of an unavailable measurement is related to a participant's condition, treatment experience or outcome; the direction and size of any such effect cannot be determined without information about the missing data and the analysis approach.

The primary endpoint population is defined as all enrolled participants who receive at least 1 dose of study drug. The registry record does not report a broader intention-to-treat population definition, the number randomized in each group, or how the listed efficacy-oriented and pharmacokinetic outcomes were analyzed. It also does not provide analysis denominators for those outcomes. As a result, the relationship between enrollment, treatment exposure and outcome-specific data availability cannot be fully assessed.

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 safety record lists 10 participants at risk in LY3502970 Cohort 1, 10 in LY3502970 Cohort 2 and 4 in the placebo group. Serious adverse events affected 0 participants in each group, and deaths were also recorded as 0 in each group. For other adverse events, the listed affected counts are 10 in Cohort 1, 10 in Cohort 2 and 3 in the placebo group. These are counts, not estimates of comparative risk adjusted for follow-up or exposure.

The serious-event figures describe what was recorded in these groups during the study. They do not establish that serious events are impossible or that the treatments have equivalent safety. The group sizes are small, and the record does not provide uncertainty intervals or a formal statistical comparison for these counts.

The primary safety endpoint is narrower in one respect: it counts participants with treatment-emergent events considered related to study drug by the investigator. The adverse-event summary is described as including events regardless of causality. Thus, zero serious adverse events in the group summaries does not by itself provide the number of participants with the primary endpoint, which also includes related non-serious events. That endpoint's numerical result is not reported in the registry record.

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

The registry record establishes that this completed phase 1 study enrolled 24 Chinese participants with obesity or overweight with weight-related comorbidities and compared oral LY3502970 regimens with oral placebo. The active-treatment cohorts followed different titration schedules and durations. The posted safety counts record zero serious adverse events and zero deaths in each group, alongside other adverse-event counts for the active-treatment and placebo groups. These are observations from the participants included in the registry record.

Those observations do not answer every safety question. The primary endpoint is based on events considered related to study drug by the investigator, but its numerical result is not reported. The broader adverse-event counts are described regardless of causality, so they cannot substitute for the primary endpoint result. Nor can a zero count in a small study demonstrate the absence of a possible event or establish that groups have the same safety profile.

The study also planned pharmacokinetic and pharmacodynamic assessments. The record names the concentration outcomes and changes in body mass index, body weight, waist circumference and fasting plasma glucose, but supplies no numerical estimates for them. It therefore does not show how these measurements changed, how variable the measurements were, or how LY3502970 compared with placebo on those outcomes. No inferential analysis or confidence interval is reported for these results.

Accordingly, the posted information supports a description of the trial design and recorded adverse-event counts, not a conclusion about the magnitude or precision of treatment effects. A completed status indicates that the study is listed as completed; it does not itself establish that all planned outcomes were reported or that the available estimates are sufficiently precise for broader conclusions. The registry record does not report the protocol's sample-size justification or detailed statistical analysis plan, further limiting assessment of what comparisons were intended and how they were to be interpreted.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why design labels and outcome definitions need to be read together. Randomization, double masking and parallel assignment describe important features of how treatment groups were organized. The two active-treatment cohorts nevertheless had different escalation schedules and durations, which affects how their observations should be understood and cautions against treating them as interchangeable replications of one regimen.

The study also illustrates the distinction between an outcome's definition and the data reported for it. The primary endpoint focuses on treatment-emergent events judged related to study drug, whereas the adverse-event summary is described as covering events regardless of causality. The posted group counts therefore do not directly report the endpoint named as primary. Recognizing that difference prevents an all-cause safety summary from being mistaken for a treatment-related endpoint result.

Enrollment was 24, and the reported group counts are limited. In general, small studies can identify descriptive patterns and contribute early information, while providing limited precision for comparisons and limited ability to characterize uncommon events. A zero serious-event count is still an observation worth reporting, but its interpretation depends on the number of participants observed, their exposure and follow-up, and the uncertainty around the estimate. The registry record does not report uncertainty intervals or formal comparative analyses.

Finally, the listed pharmacokinetic and pharmacodynamic outcomes show that the study's aims extended beyond adverse events, but numerical results for those measures are not reported in the registry record. For a statistical reader, this separation between planned outcomes and available results is consequential: endpoint names establish what was intended to be measured, not what the data ultimately demonstrate. Clear outcome-specific estimates, analysis populations and missing-data methods would be needed to assess the evidence more fully.

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 reports the primary endpoint definition and timeframe but not its numerical result. Its safety group summaries distinguish serious events from other events and describe the latter categories regardless of causality. Because the primary endpoint requires investigator attribution to study drug, the available counts do not show how many participants met that specific definition.

Although the study is listed as randomized and double-masked, procedural details are not reported in the registry record. The allocation sequence, concealment approach, masking procedures and allocation ratio are not described. The record also does not provide the number randomized to each group, although it gives at-risk counts in the adverse-event summary. These gaps restrict evaluation of the conduct and balance of the groups.

The active-treatment cohorts differed in dose-escalation sequence and duration. Their results, if available, would need to be interpreted in light of those regimen differences. The placebo regimen is described as oral once daily, but further dosing details are not reported. The registry record does not give participant-level exposure, adherence, treatment discontinuation or follow-up completeness.

Numerical results for the listed pharmacokinetic and pharmacodynamic outcomes are not reported in the registry record, nor are estimates of variability, confidence intervals, p-values or formal comparisons. The statistical analysis plan, sample-size justification, multiplicity approach and missing-data methods are also not reported. These limitations prevent assessment of the precision of outcome estimates, the handling of incomplete data, and whether the reported outcomes were analyzed according to prespecified methods.

The enrollment of 24 also means that observed safety counts should be interpreted descriptively. The record does not support precise estimates of uncommon events or definitive comparative conclusions. These limitations are specific to the information recorded and do not establish what may be available in other study documents.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities — NCT06023095.
• Registry record last updated 2026-07-17; status last verified 2026-06.
• Results first posted 2026-07-17.
• 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

NCT06023095 is a completed randomized, double-masked, parallel phase 1 study sponsored by Eli Lilly and Company. It enrolled 24 Chinese participants with obesity or overweight with weight-related comorbidities and compared oral LY3502970 with oral placebo. The active-treatment schedule escalated through 12 mg in Cohort 1 over 16 weeks and through 36 mg in Cohort 2 over 24 weeks. The record lists zero serious adverse events and zero deaths in each group, alongside other adverse-event counts. Numerical results for the primary endpoint and the listed pharmacokinetic and pharmacodynamic outcomes are not reported in the registry record. The statistical analysis plan, sample-size justification, multiplicity approach and missing-data methods are also not reported.