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 Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes (NCT07030868), a randomized phase 2 study. The primary outcome is Percent Change From Baseline in Body Weight.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT07030868 |
| Phase | Phase 2 |
| Condition | Obesity, Overweight, Type 2 Diabetes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Adults with obesity or overweight and type 2 diabetes were the intended population. The registry record states that 1 participant enrolled before the study was terminated for strategic business reasons. That participant did not receive study intervention or undergo post-baseline assessments.
Intervention
The study planned three LY3549492 groups: low dose, high dose with fast titration, and high dose with slow titration. Each group was described as receiving LY3549492 orally. Dose amounts and detailed titration schedules are not reported in the registry record.
Comparator
The comparator was an oral placebo group. The study was described as randomized, double-blind, and parallel-group, with four arms overall. The registry record does not report how randomization was implemented or which specific comparisons were designated for analysis.
Primary question
The primary endpoint was percent change from baseline in body weight at Week 32. The question was whether body-weight change differed among the LY3549492 treatment groups and placebo. Because the enrolled participant received no intervention and had no post-baseline measurement, the registry record contains no outcome data to answer that question.
3. Trial Design
This was a Phase 2, randomized, double-blind, parallel-group study of LY3549492 tablets compared with placebo in adults with obesity or overweight and type 2 diabetes. Its official title describes a four-arm design. The arms were LY3549492 low dose, LY3549492 high dose with fast titration, LY3549492 high dose with slow titration, and placebo. The descriptions specify oral administration, but dose levels, titration schedules, treatment duration, and other operational details are not reported in the registry record.
The study was performed under the master protocol W8M-MC-CWMM (NCT06143956). The registry record gives a planned participation duration of about 11 months. The listed start date is 2025-06-19 and the primary completion date is 2025-07-29. The study status is terminated; the stated reason was strategic business reasons.
Although randomization and double blinding were part of the design, enrollment stopped after 1 participant. That participant was not treated and did not have post-baseline assessments. Thus, the planned parallel-group comparison was not carried out in a way that generated outcome data. Details such as allocation concealment, the randomization procedure, blinding procedures, and the target enrollment are not reported in the registry record. The record does not give a statistical analysis plan or a planned 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 | LY3549492 or Placebo (Randomised, Not Treated) |
|---|---|
| STARTED | 1 |
| Received at Least One Dose of Study Drug | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
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 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.
| Characteristic | Unit | LY3549492 or Placebo (Randomised, Not Treated) |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percent Change From Baseline in Body Weight, measured over Baseline, Week 32.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was percent change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, with percent change calculated relative to the participant's baseline weight. This type of endpoint expresses change in relation to the starting measurement rather than only reporting a follow-up weight. In general, a relative measure can help describe change across participants whose baseline measurements differ, although its interpretation still depends on having both baseline and follow-up data.
The endpoint was intended to assess body-weight change during treatment and to support comparisons among the LY3549492 regimens and placebo. The registry record does not specify which treatment contrasts were to be primary, how repeated measurements would be handled, or what summary statistic would be used for the comparison.
No primary endpoint result is available. The study ended after enrollment of 1 participant, who did not receive study intervention and had no post-baseline assessments. Consequently, there was no follow-up body-weight value from which to calculate the planned change. The endpoint definition describes what the study intended to measure; it is not evidence of an observed treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record reports no outcome measures data. The study was terminated for strategic business reasons after enrollment of 1 participant. That participant did not receive study intervention and did not undergo post-baseline assessments before termination. Therefore, the planned Week 32 body-weight endpoint was not observed, and no comparison between LY3549492 and placebo can be estimated from this record.
The study's design describes a randomized, double-blind, four-arm comparison. Those design features indicate how the trial was intended to organize treatment groups, but they do not generate evidence by themselves. In the absence of treated participants with follow-up measurements, there is no estimate of the effect of any LY3549492 regimen, no uncertainty interval for such an estimate, and no statistical test of a treatment contrast reported in the registry record. The analysis count is recorded as zero.
The adverse-event record lists a group titled “LY3549492 or Placebo (Randomised, Not Treated)” and records zero events in the listed categories. Because the participant was not treated, those entries should not be read as evidence about adverse events during exposure to LY3549492 or placebo. With no treatment exposure, these entries cannot establish that either intervention is free of harm.
General statistical context: an effect estimate describes the magnitude and direction of a difference, while a confidence interval describes the precision compatible with the data and the analysis method. Neither can be obtained for the primary outcome when the outcome was not measured after baseline. A p-value likewise cannot answer the treatment question without an analysis of relevant outcome data. The record contains no such estimate, interval, or test.
The absence of results is not a finding that the regimens had equal effects, nor is it evidence that they had different effects. It means the trial did not produce the measurements needed to assess the registered primary question. Any planning illustration based on an observed effect would also lack an observed effect to use in this case; it must not be interpreted as a trial result or as observed power.
9. Statistical Methods Explained
What does randomization contribute?
General statistical context: randomization assigns participants to treatment groups using a chance-based process. When implemented as planned, it can reduce systematic differences between groups in factors that are measured or unmeasured at baseline. It does not guarantee that groups will be identical, and it cannot compensate for an absence of outcome measurements. The registry record identifies the study as randomized but does not describe the allocation procedure. With enrollment of 1 participant and no treatment or post-baseline assessments, there are no group outcome data on which to base a randomized comparison.
What does a parallel-group design mean?
In a parallel-group study, participants are assigned to a group and the groups are followed under their assigned regimens. This design was described as having four arms: three LY3549492 regimens and placebo. The listed intervention descriptions say that LY3549492 and placebo would be administered orally. The actual dose amounts and titration schedules are not reported in the registry record. The record also does not provide treatment exposure or follow-up outcome results, so the planned group structure does not yield an estimate of relative effects.
What does double blinding mean statistically?
General context: masking is intended to limit the influence of knowledge about treatment assignment on participant behavior, care, outcome assessment, or analysis. The registry record labels the study double-blind, but does not explain who was masked, how masking was maintained, or how it would be assessed. Since the participant was not treated and no post-baseline outcome was collected, masking cannot support interpretation of a treatment comparison in this study record.
How should the body-weight endpoint be read?
The primary measure was percent change from baseline in body weight at Week 32. In general, a change-from-baseline endpoint compares a follow-up measurement with a starting measurement; a percentage expresses that change relative to the starting value. The record says body weight was intended to be measured in kilograms. It does not report a baseline measurement or a Week 32 measurement for the enrolled participant. There is therefore no observed endpoint value to summarize or compare.
Why do estimates and uncertainty matter?
General statistical context: an estimate gives a numerical summary of the treatment contrast, and a confidence interval indicates the range of values reasonably compatible with the data under the stated method. A p-value evaluates the compatibility of the observed data with a specified null hypothesis under an analysis model. These quantities depend on outcome data and a defined analysis. None is reported for the primary endpoint, and the record lists zero analyses. The statistical analysis plan, including the intended model, covariate adjustment, handling of repeated measurements, and hypothesis-testing procedures, is not reported in the registry record.
What about variability and model assumptions?
General context: statistical models make assumptions about how measurements vary and how outcomes relate to treatment and other variables. Those assumptions influence estimated effects and their uncertainty. For a continuous outcome such as body weight or its change, a model might account for variation across participants, but the specific approach must come from a trial's analysis plan. No model or dispersion estimate is available in this record. Since there are no post-baseline body-weight observations, no assessment of variability, model fit, or over-dispersion can be made for the primary endpoint.
Can planning calculations be interpreted as evidence?
No. A sample-size illustration based on an observed effect is a planning exercise, not a finding from the trial and not observed power. In general, such illustrations require an effect estimate and assumptions about significance level, allocation, and the statistical approximation. The stated planning framework refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. But this study has no observed primary effect to anchor such an illustration, and the design includes four arms rather than one reported two-arm primary comparison. The registry record also notes that the primary outcome has fewer than two arms available for the relevant comparison. The sponsor's analysis takes precedence if a recalculated analysis conflicts with it; no sponsor outcome analysis is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists the primary endpoint as percent change from baseline in body weight at Week 32. It also lists secondary outcomes concerning change in body weight, participants achieving body-weight reductions of at least 5% and at least 10%, change in hemoglobin A1c, and the average concentration of LY3549492. The record gives 6 outcome measures, but the listed secondary outcomes do not provide results. No analyses are recorded.
Multiplicity concerns arise when a study tests several outcomes, treatment contrasts, time points, or subgroups. General statistical context: testing multiple hypotheses can increase the chance of a false-positive result unless the analysis plan addresses that issue. Whether and how multiplicity was to be controlled is not reported in the registry record. The planned primary treatment contrasts and any hierarchy among outcomes are also not reported.
There are no post-baseline outcome measurements for the enrolled participant, so the primary and secondary outcomes have no collected follow-up data in this record. This is not the same as a set of observed outcomes with some values missing; the registry specifically states that no outcome measures data was collected. The record does not report an imputation method, a missing-data sensitivity analysis, or rules for handling participants without follow-up.
The analysis populations are not reported in the registry record. In particular, the record does not describe how participants would be included in an intention-to-treat, per-protocol, or safety analysis. The only participant was randomized but not treated, and no post-baseline assessments were performed. These circumstances do not support estimating treatment effects or evaluating the consequences of an analysis-population choice.
11. What the Result Does, and Does Not, Mean
The result that can be stated is a study-status and data-availability result: the trial was terminated for strategic business reasons after enrollment of 1 participant, and that participant did not receive intervention or have post-baseline assessments. As a consequence, the registry record reports no outcome measures data. The primary body-weight question therefore remains unanswered by this trial record.
This does not show that LY3549492 reduced body weight, increased body weight, or had the same effect as placebo. It does not show that one titration approach was better than another. There is no observed Week 32 body-weight change, treatment contrast, confidence interval, or hypothesis test to support any of those conclusions.
Likewise, the adverse-event entries for the randomized, not-treated group do not establish the safety profile of LY3549492 or placebo during treatment. No participant received study intervention, according to the registry description, so the zero event entries should not be interpreted as evidence about events under exposure.
General statistical context: a trial may be well described in its protocol or registry and still fail to provide an estimate if it does not collect the outcome data needed for analysis. Design labels such as randomized, double-blind, and parallel-group describe intended features; they are not substitutes for observed outcomes. Here, termination before treatment and follow-up prevents assessment of both the magnitude and the precision of a treatment effect.
The record also cannot establish that the study was underpowered, because no sample-size justification or completed analysis is reported. A planning calculation is not observed power and cannot recover an effect that was never measured. The appropriate interpretation is limited: the planned comparison was not evaluated using collected outcome data, and no conclusion about efficacy or treatment-related safety follows from the missing results.
12. Why This Trial Matters Statistically
This study illustrates the distinction between a trial's intended design and the evidence it actually generates. Randomization, double blinding, and a parallel-group structure can be important features of a comparative study. Their value for estimating treatment effects depends, however, on participants receiving the assigned interventions and relevant outcomes being measured. In this case, the registry record reports that the study stopped after enrollment of 1 participant, who was not treated and had no post-baseline assessments.
That distinction matters for statistical interpretation. A registered endpoint is a plan for measurement, not an observed result. Without a Week 32 body-weight outcome, there is no effect estimate and no way to assess its precision. A zero in an adverse-event listing for a not-treated group is also fundamentally different from a finding of no events during treatment exposure.
The record further demonstrates why analysts should distinguish the existence of a trial from the availability of analyzable evidence. The study's four-arm structure and intended comparison of several LY3549492 regimens with placebo do not provide comparative results when no post-baseline outcomes were collected. Nor can generic planning assumptions replace observations from the trial.
For biostatisticians and clinical researchers, the key lesson is to make the boundary of inference explicit. The record documents an intended study and its termination, but it does not support a claim about the effects of LY3549492 on body weight or about treatment-related adverse events. Clear reporting of that boundary prevents design information and empty outcome records from being mistaken for clinical findings.
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 the study produced no outcome measures data. The registry record states that it ended for strategic business reasons after enrollment of 1 participant. That participant did not receive study intervention and did not undergo any post-baseline assessments. The primary endpoint at Week 32 therefore has no observed value, and none of the listed secondary outcomes can be interpreted as a treatment result.
The record does not report the intended target enrollment or a sample-size justification. It also does not report the detailed statistical analysis plan, planned treatment contrasts, model specification, multiplicity approach, missing-data strategy, or analysis populations. These omissions prevent evaluation of how the study would have estimated effects if follow-up data had been collected.
The intervention descriptions do not state dose amounts or detailed titration schedules. The registry record does not describe randomization implementation or the practical procedures used to maintain double blinding. Those details cannot be inferred from the design labels.
The adverse-event entries refer to a randomized, not-treated group. They cannot characterize events during exposure to either intervention. In addition, no outcome comparison can be reconstructed from the available record, and no efficacy or safety conclusion should be drawn from the absence of collected data.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes — NCT07030868.
- Registry record last updated 2026-08-31; status last verified 2026-08.
- Results first posted 2026-08-31.
- 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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17. Record Summary
NCT07030868 was a Phase 2 randomized, double-blind, parallel-group study comparing three oral LY3549492 regimens with oral placebo in adults with obesity or overweight and type 2 diabetes. The primary endpoint was percent change from baseline in body weight at Week 32.
The study was terminated for strategic business reasons after enrollment of 1 participant. The participant did not receive study intervention and had no post-baseline assessments. No outcome measures data or analyses are reported. The record therefore does not provide an estimate of the effect of LY3549492 on body weight or a treatment-exposure safety assessment.