A Study of LY3549492 in Healthy Weight Adult Participants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of LY3549492 in Healthy Weight Adult Participants (NCT07085468), a randomized phase 2 study. The primary outcome is Number of Participants With One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration.

2. Clinical Question

The registry describes a Phase 2 study designed to investigate the safety and tolerability of LY3549492 compared with placebo in adults with a healthy BMI. The planned comparison involved two LY3549492 dose groups and a placebo group. The primary endpoint focused on serious adverse events considered related to study drug administration. The record also lists percent change from baseline in body weight and adverse events leading to permanent discontinuation of study intervention or withdrawal as secondary outcomes.

The intended clinical question cannot be answered with observed trial results. The study was terminated for strategic business reasons after the enrollment of 1 participant. That participant did not receive study intervention and did not undergo post-baseline assessments before termination. Consequently, the registry record reports that no outcome measures or safety data were collected. The record therefore describes the question the study was designed to address, but offers no participant-level treatment experience with which to compare LY3549492 and placebo.

3. Trial Design

The registry identifies this as a randomized, double-blind, parallel-group Phase 2 study. The planned arms were 15 mg LY3549492, 60 mg LY3549492, and matching placebo. Each intervention was planned as an oral once-daily regimen for 48 weeks. The official title specifies adults aged 55 to 80 years with a BMI of 22 to 25 kg/m2; the condition is listed as healthy. Participation was described as lasting about 13 months.

The study began on 2025-07-21, and the listed primary completion date is 2025-08-14. Its status is terminated. The registry states that termination occurred for strategic business reasons after the enrollment of 1 participant. That participant did not receive any study intervention and did not undergo post-baseline assessments before the study ended.

These details describe the intended design, not a completed comparison of the planned groups. Although the study was randomized and double-blind by design, the record does not report any participant receiving an assigned intervention. The allocation ratio and the operational details of randomization and masking are not reported in the registry record. There are no reported outcome analyses, and the record states that no outcome measures or safety data were collected. Thus, the planned parallel-group design cannot be evaluated for balance, adherence, masking success, or comparative treatment effects using observed study results.

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: The study was terminated for strategic business reasons after the enrollment of 1 participant. The enrolled participant did not receive any study intervention and did not undergo any post-baseline assessments prior to study termination. Therefore, no outcome measures or safety data was collected and no analyses could be performed.

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 Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration, measured over Baseline through Week 48.

The primary endpoint was the number of participants with one or more serious adverse events that the investigator considered related to study drug administration. Its stated timeframe was baseline through Week 48. The endpoint was intended to capture serious harms and to attribute their relationship to study drug according to the investigator's assessment.

As a general statistical concept, a count of participants experiencing an event can summarize how often a safety outcome occurs in a defined group and period. The relatedness criterion narrows the endpoint to serious events judged by the investigator to be connected to administration of study drug. This type of measure is relevant to a study whose stated purpose is evaluating safety and tolerability.

However, an endpoint can be defined without being observed. In this record, the enrolled participant did not receive intervention or complete post-baseline assessments, and no safety data were collected. The registry therefore contains no observed endpoint value or comparative estimate. The primary endpoint's intended meaning should not be confused with evidence about the frequency of serious adverse events under either LY3549492 dose or placebo.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-blind, parallel-group design, but no statistical analysis of trial outcomes is reported. The record states that the study ended after the enrollment of 1 participant, who received no study intervention and had no post-baseline assessments. The methodological discussion below distinguishes the intended design from general statistical principles; it does not imply that these analyses were carried out.

What does randomization contribute?

In general, randomization assigns participants to treatment groups using a chance-based process. When enough participants are enrolled and the process is implemented as intended, it can help balance measured and unmeasured participant characteristics across groups. That balance supports interpretation of differences in outcomes as treatment-group comparisons rather than as simple differences in who entered each group. The registry identifies randomization as planned, but does not report the allocation ratio or the details of sequence generation and concealment. Since the participant did not receive an intervention, the record supplies no randomized treatment experience to analyze.

What does double blinding mean statistically?

In general, blinding is intended to reduce the influence of treatment knowledge on participant behavior, clinical care, and outcome assessment. A double-blind designation indicates that blinding was part of the planned design, but it does not by itself show whether masking was maintained or successful. The registry record does not report operational masking details or an assessment of masking. With no intervention administered and no outcomes collected, the record cannot show whether blinding affected outcome measurement.

How should the primary endpoint be analyzed?

The primary outcome was a count of participants with one or more serious adverse events judged by the investigator to be related to study drug administration, within the baseline-through-Week-48 timeframe. In general, a group-level analysis of such an endpoint would require observed safety follow-up and a defined analysis population. Depending on the prespecified method, results could be expressed as group-specific event counts or as a comparison between groups. The registry record does not report a statistical analysis plan, a method for handling event attribution, or an analysis population. Most importantly, it reports that no safety data were collected, so there are no endpoint observations to analyze.

Why do denominators matter?

In general, an event count is interpreted in relation to the participants observed and the duration or completeness of their follow-up. A count alone cannot establish how common an event was if the number of participants at risk and their observation time are unknown or absent. Here, the registry's adverse-event listing records no participants at risk in the planned groups, while the narrative explains that no intervention or safety data were collected. The zero entries therefore do not function as event rates or as evidence of safety during treatment. There is no observed treated-group denominator from which to estimate the frequency of events.

What can a confidence interval or test add?

As a general principle, a confidence interval communicates the range of values reasonably compatible with an estimate under specified statistical assumptions. A hypothesis test evaluates how compatible the observed data are with a stated null model. Both rely on data and a defined analysis. Because the registry reports no collected outcomes and 0 analyses, it gives no estimate, confidence interval, or test result for the planned endpoints. No conclusion about the direction or precision of a treatment effect can be drawn.

How should planning calculations be read?

The registry describes its planning illustration as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a fraction of the observed effect. It also distinguishes participant-per-arm calculations from total event counts for time-to-event calculations. These are planning assumptions, not observations from the trial and not observed power. The registry record reports no outcome measures or safety data from which an observed effect could be obtained, so such a planning illustration cannot serve as evidence of an effect in this study. The trial's own sample-size justification is not reported in the registry record.

The registry does not report the statistical plan for the primary or secondary outcomes, the treatment of missing data, adjustment for multiple outcomes, or the definitions of analysis populations. These omissions matter for interpreting a completed trial, but they do not change the central issue: no post-baseline outcome data were collected for statistical analysis.

10. Multiplicity, Missing Data and Analysis Populations

The record lists a primary safety endpoint and secondary outcomes concerning percent change from baseline in body weight and adverse events leading to permanent discontinuation or withdrawal. A multiplicity strategy for interpreting results across these outcomes is not reported in the registry record. In general, when a study tests several outcomes, a statistical plan may specify how to control the chance of false-positive findings across those tests. No such plan or outcome tests are reported, and the absence of collected outcomes means that multiplicity does not lead to any reported inferential result.

The registry reports that the enrolled participant did not receive study intervention and did not undergo post-baseline assessments before termination. It also states that no outcome measures or safety data were collected. This is not a case in which an outcome value is reported with some follow-up values missing: the record says that outcome data were not collected. A method for handling missing outcome data, including any imputation approach or sensitivity analysis, is not reported in the registry record.

Analysis populations such as an intention-to-treat or safety population are not defined in the registry record. The record does not report how participants would have been included in each analysis, nor does it report a statistical analysis plan. As a general principle, an analysis population defines which participants contribute to a particular estimate and helps readers understand how departures from the planned treatment process are handled. In this record, there are no intervention exposures or post-baseline outcomes to form a treatment-effect analysis. The lack of a reported population definition should therefore be noted, but it cannot be resolved by assuming a conventional approach.

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

The record's result is that the planned study ended before treatment or outcome assessment. It does not report evidence about the effects of 15 mg LY3549492, 60 mg LY3549492, or placebo on the listed safety outcomes or body weight. The participant's non-exposure to study intervention means the study did not generate the intended comparison between treatment groups.

The zero entries in the adverse-event listing do not mean that no serious adverse events or other harms occur with LY3549492. There were no participants at risk in the planned arms in the listing, and the registry explicitly states that no safety data were collected. The same reasoning applies to deaths and the secondary adverse-event outcome: absence of collected observations is not the same as a measured outcome with no events.

As a general statistical concept, a study can be uninformative about an effect when its intended measurements are never obtained. In that situation, it is not possible to estimate the size of an effect or how precisely it has been estimated. The record therefore cannot establish either a benefit or a lack of benefit, and it cannot establish either the presence or absence of a safety concern.

The termination reason is reported as strategic business reasons. The record does not attribute termination to an observed safety result, an efficacy finding, or a statistical analysis. It also does not report enough information to assess the original sample-size justification or the planned statistical analysis. The appropriate interpretation is limited: the registry documents a planned trial and its early termination, but offers no outcome evidence from which to infer a treatment effect.

12. Why This Trial Matters Statistically

This record illustrates the distinction between a trial's planned question and the evidence it actually produces. The design specified randomized, double-blind comparisons of two LY3549492 doses with placebo, with a safety endpoint assessed through Week 48 and secondary outcomes also listed. Yet the study ended after the enrollment of 1 participant, before that participant received intervention or completed post-baseline assessments. The central statistical result is therefore the lack of collected outcome data, not a treatment estimate.

This distinction matters because registry displays can include outcome definitions and group-level entries even when no trial observations support a comparison. An event count of zero is only informative when the relevant participants were observed and the outcome was assessed. Here, the record explicitly says that no safety data were collected. Reading the zero entries as proof of no events would confuse an empty observation record with a measured absence of events.

The record also demonstrates why design labels do not guarantee analyzable results. Randomization and blinding describe the intended methods; they cannot substitute for intervention exposure, follow-up, and outcome measurement. Likewise, a planning calculation does not show that the intended precision or power was achieved. Statistical interpretation depends on the data collected, the analysis plan, and the population observed. With those elements unavailable for outcome analysis, the study cannot answer its clinical question.

13. 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 is that no outcomes or safety data were collected. The registry says that the study was terminated for strategic business reasons after the enrollment of 1 participant, who did not receive any study intervention or undergo post-baseline assessments. As a result, there is no observed treatment comparison, no estimate of the primary endpoint, and no reported result for the secondary outcomes.

The planned follow-up period and interventions do not describe what the participant experienced. The regimens were planned for 48 weeks, and participation was described as about 13 months, but the registry reports no intervention exposure or post-baseline measurement. The primary endpoint's baseline-through-Week-48 timeframe is thus a planned assessment period, not a period with reported safety observations.

The registry does not report the allocation ratio, detailed randomization or masking procedures, the statistical analysis plan, analysis populations, missing-data methods, multiplicity procedures, or the study's sample-size justification. These limitations constrain assessment of the planned methods. They are secondary, however, to the absence of collected outcomes: even a fully specified statistical plan could not yield a treatment-effect estimate without outcome observations.

The planned sample-size assumptions refer to detecting a fraction of an observed effect, but the record reports no observed outcome data from this study. No planning illustration can be interpreted as achieved power or as evidence about treatment effects. The registry record supports a description of the intended trial and its termination, but not a quantitative conclusion about LY3549492's safety or effect on body weight.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: A Study of LY3549492 in Healthy Weight Adult Participants — NCT07085468.
• Registry record last updated 2026-09-21; status last verified 2026-09.
• Results first posted 2026-09-21.
• 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.

17. Record Summary

NCT07085468 was a Phase 2 randomized, double-blind, parallel-group study planned to investigate LY3549492 versus placebo in healthy-weight adults aged 55 to 80 years with a BMI of 22 to 25 kg/m2. The planned arms were 15 mg LY3549492, 60 mg LY3549492, and matching placebo, each taken orally once daily for 48 weeks.

The study began on 2025-07-21 and has a listed primary completion date of 2025-08-14. Its status is terminated. The registry reports termination for strategic business reasons after the enrollment of 1 participant. That participant received no study intervention and had no post-baseline assessments before termination. The record states that no outcome measures or safety data were collected.

The primary endpoint concerned serious adverse events considered related to study drug administration. The registry also lists body-weight change and adverse events leading to permanent discontinuation or withdrawal as secondary outcomes. No outcome analyses are reported, so the record does not establish comparative safety or treatment effects.