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 Multiple-dose Study of LY3031207 in Healthy Participants (NCT01632566), a randomized phase 1 study. The primary outcome is Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01632566 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 39 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy Japanese and non-Japanese participants were studied. The primary-outcome population is defined as participants who received at least one dose of study drug.
Intervention
Participants received daily oral LY3031207 at doses from 25 mg up to 450 mg for 28 days. Some groups received LY3031207 with simvastatin, which was also given as a single open-label dose before and after the 28-day dosing period.
Comparator
The study included placebo, including placebo with or without simvastatin, and 400 mg celecoxib as a positive control. The registry also lists a 10 mg simvastatin group.
Primary question
The primary outcome was the number of participants with one or more drug-related adverse events or any serious adverse events. The study also aimed to assess tolerability, drug exposure and elimination, effects on simvastatin exposure, blood pressure, and urinary prostacyclin and prostaglandin metabolites.
This is a safety and pharmacology question in healthy participants, not a test of clinical benefit for a disease. The primary outcome combines events distinguished by seriousness and drug relationship, while the posted adverse-event counts are described as covering events regardless of causality. Those counts therefore do not by themselves give a direct, complete comparison for the primary outcome as titled.
The registry reports no primary-outcome analysis. It also does not report an inferential comparison between LY3031207 doses and placebo or celecoxib. The available record supports a descriptive account of the registered study and its adverse-event counts, but not a conclusion about comparative risk or the size of a treatment effect.
3. Trial Design
This was a phase 1 randomized, double-blind, parallel-group study with an enrollment of 39. It studied healthy participants and evaluated multiple doses of LY3031207. The registry lists the study status as terminated, with a start in 2012-06 and primary completion in 2013-04. The reason for termination is not reported in the registry record.
The treatment groups included placebo, LY3031207 at doses from 25 mg up to 450 mg, and 400 mg celecoxib, described as a positive control. Some groups received simvastatin in addition to LY3031207 or placebo. In those groups, participants received 75 mg or 225 mg LY3031207 daily for 28 days and a single open-label 10 mg simvastatin dose before and after that dosing period. A separate 10 mg simvastatin group is also listed. The registry does not report the allocation ratio or the number randomized to each assigned arm.
The primary safety outcome covered baseline through study completion, including treatment completion and follow-up, for up to 35 weeks. Its title refers to participants with one or more drug-related adverse events or any serious adverse events. The registry describes treatment-emergent adverse events as events that begin after dosing, or events present before dosing that become more severe after dosing. It says the primary outcome presentation includes all causalities and severities; the Reported Adverse Events module contains a summary of serious and other non-serious events regardless of causality.
Other registered outcomes concern LY3031207 and simvastatin pharmacokinetics, including maximum concentration, area under the concentration curve, and time of maximum concentration. The registry also lists changes from baseline to Day 28 in urinary prostacyclin and prostaglandin E metabolite excretion. The specific statistical analysis plan and the reason for terminating the study are not reported in the registry record.
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.
Before assignment: Study enrolled participants of both Japanese and non-Japanese decent. Participants were pooled regardless of ethnicity. Participants assigned to 75 milligrams (mg) LY3031207 and 225 mg LY3031207 underwent identical procedures as those assigned to 25 mg LY3031207 with the addition of 10 mg open-label simvastatin administration on Days -3 and 28.
Overall Study
| Stage | 25 mg LY3031207 | 75 mg LY3031207 and Simvastatin | 225 mg LY3031207 and Simvastatin | Placebo With or Without Simvastatin | 400 mg Celecoxib With or Without Simvastatin |
|---|---|---|---|---|---|
| STARTED | 8 | 10 | 9 | 6 | 6 |
| Received at Least One Dose LY3031207 | 8 | 10 | 9 | 0 | 0 |
| Received at Least One Dose Simvastatin | 0 | 10 | 9 | 4 | 4 |
| COMPLETED | 8 | 7 | 0 | 4 | 4 |
| NOT COMPLETED | 0 | 3 | 9 | 2 | 2 |
Reasons for not completing this period:
| Reason | 25 mg LY3031207 | 75 mg LY3031207 and Simvastatin | 225 mg LY3031207 and Simvastatin | Placebo With or Without Simvastatin | 400 mg Celecoxib With or Without Simvastatin |
|---|---|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
| Sponsor Decision | 0 | 2 | 9 | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: Participants who received at least one 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: Participants who received at least dose of study drug.
| Characteristic | Unit | 25 mg LY3031207 | 75 mg LY3031207 and Simvastatin | 225 mg LY3031207 and Simvastatin | Placebo With or Without Simvastatin | 400 mg Celecoxib With or Without Simvastatin | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 8 | 10 | 9 | 6 | 6 | 39 | |
| Age, Continuous | years | 37.8 (SD 11.8) | 39.0 (SD 11.5) | 45.1 (SD 14.7) | 52.7 (SD 5.8) | 44.0 (SD 7.8) | 43.0 (SD 11.9) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 4 | 2 | 0 | 9 |
| Sex: Female, Male: Male | Participants | 7 | 8 | 5 | 4 | 6 | 30 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 10 | 9 | 6 | 6 | 38 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 2 | 3 | 3 | 2 | 12 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 5 | 6 | 3 | 2 | 4 | 20 |
| Race (NIH/OMB): More than one race | Participants | 1 | 2 | 3 | 1 | 0 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 8 | 10 | 9 | 6 | 6 | 39 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs, measured over Baseline to study completion (treatment completion and follow-up, up to 35 weeks).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is a count of participants who experienced one or more drug-related adverse events or any serious adverse events. It is a participant-level safety measure: a participant is counted as having an event rather than the outcome being a measure of how many event episodes occurred. The registry identifies the outcome unit as participants and defines the analysis population as people who received at least one dose of study drug.
Safety outcomes are used in early-phase studies to describe the kinds of events observed during exposure and to assess tolerability. A participant count can summarize how many people had an event, but by itself does not describe event duration, severity beyond the serious/non-serious distinction, timing, or whether multiple events occurred in the same person. Those details require additional outcome definitions or event-level reporting.
The endpoint title combines drug-related events with any serious events, while the outcome description says the presented events include all causalities and severities. The registry directs readers to the adverse-event module for serious and other non-serious events regardless of causality. This distinction matters: counts from that module are useful safety descriptions, but they are not necessarily a direct estimate of the specifically titled composite endpoint. A full endpoint analysis and its comparison across groups are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports participants at risk and participants with serious or other non-serious adverse events for six listed groups. For serious events, the counts are 0 of 6 in placebo with or without simvastatin, 0 of 8 with 25 mg LY3031207, 0 of 10 with 75 mg LY3031207 and simvastatin, 2 of 9 with 225 mg LY3031207 and simvastatin, 0 of 6 with 400 mg celecoxib with or without simvastatin, and 0 of 27 with 10 mg simvastatin. These are descriptive counts, not adjusted or inferential comparisons.
For other non-serious events, the registry reports 1 of 6 participants in the placebo group, 3 of 8 with 25 mg LY3031207, 5 of 10 with 75 mg LY3031207 and simvastatin, 9 of 9 with 225 mg LY3031207 and simvastatin, 1 of 6 with celecoxib, and 3 of 27 with simvastatin. The record does not provide a statistical test or confidence interval for these group counts. The numbers should therefore be read as observed descriptions in the listed groups, not as proof of a difference between treatments.
The serious-event count is not uniformly zero across the groups: the registry records 2 affected participants in the 225 mg LY3031207 and simvastatin group. It also identifies drug-induced liver injury as the top serious adverse-event term, at 22.2%. The record does not report the denominator or further context for that percentage in the information available for this analysis, so it should not be converted into a participant count or interpreted as a comparative rate.
Group sizes are small, and the reported counts alone provide limited precision about event frequencies beyond the participants actually observed. General statistical interpretation: when event counts are sparse, a small change in the number of observed participants can substantially affect an estimated proportion, and uncertainty intervals may be wide. No confidence intervals or hypothesis tests are reported for the displayed safety counts.
The registry lists 39 enrolled participants, but this does not establish that every enrolled participant received study drug or contributed to each listed group. The primary-outcome population is defined as participants who received at least one dose; group-specific analysis populations beyond the adverse-event counts are not reported. The record also does not report why the trial was terminated. Taken together, the posted data describe safety observations in this study but do not establish a causal or statistically precise comparison between regimens.
9. Statistical Methods Explained
Randomization assigns participants to study groups by chance. In general, this helps reduce systematic differences between groups at the outset, although it cannot guarantee that small groups will be balanced on every characteristic. The registry identifies this study as randomized but does not report the allocation ratio, the randomization procedure, or details of how assignments were generated.
Double masking means that treatment assignment is concealed from participants and study personnel described by the masking designation. In general, masking can reduce the influence of expectations on reporting or assessment. The registry identifies the study as double masked but does not report which roles were masked, how masking was maintained, or whether it was assessed. The simvastatin doses are explicitly described as open-label, so the record does not support treating that component as masked.
A parallel-group design assigns participants to a group and follows them under that assignment rather than having each participant receive every study treatment in sequence. The listed treatment groups include several LY3031207 dose regimens, placebo, celecoxib, and simvastatin-related regimens. The distinct groups make it important to distinguish comparisons that were planned from comparisons that can actually be evaluated in the posted record. No analyzed primary-outcome comparisons are reported.
What does a participant count measure?
The primary outcome is expressed as the number of participants with one or more qualifying events. This differs from counting every event: one participant with several events can still count once for a participant-level outcome. General statistical explanation: if a participant-level outcome is reduced to event/no event, it can be described as a binary outcome. Comparisons may then consider the proportion of participants with an event in each group. The registry record does not report a primary-outcome estimate or comparison using that approach.
For safety data, the distinction between serious and non-serious events is not the same as the distinction between drug-related and unrelated events. The primary outcome title includes drug-related events and any serious events. The registry's adverse-event description says that the presented events include all causalities and severities, and that serious and other non-serious events regardless of causality are reported in the adverse-event module. Consequently, those counts are not a substitute for a clearly specified analysis of the titled primary composite.
How should uncertainty be considered?
General statistical explanation: an estimate describes the observed data, while a confidence interval describes a range of values compatible with the data under a statistical model and procedure. Intervals are useful because they show precision as well as the central estimate. The registry information for this study does not include confidence intervals for the adverse-event counts or a reported primary-outcome comparison. The counts should not be read as precise population rates.
General statistical explanation: sparse binary outcomes can make asymptotic methods less dependable, especially when groups are small or counts are close to zero. Exact methods or carefully chosen model-based approaches may be considered in such settings, but the registry does not report which method was used for the primary endpoint. No statistical analysis of the primary outcome is listed.
The record describes a sample-size illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. Such a calculation is a planning illustration, not the trial's original design justification and not observed power. The record does not report the trial's own sample-size justification. Because the primary outcome has several categories or time points, it is not reduced to one comparison in the analysis information, and there is no reported primary-outcome sample-size result to interpret.
What do the other outcomes add?
The registered pharmacokinetic outcomes include maximum concentration, area under the concentration curve, and time of maximum concentration for LY3031207 and simvastatin. In general, these measures describe different features of drug concentration over time: a peak level, cumulative exposure over a period, and the time at which the peak occurs. The registry also lists urinary metabolite excretion changes and blood-pressure assessment in the study purpose. Numerical outcome results for these measures are not reported in the registry record used for this interpretation.
These outcomes are distinct from the primary safety count. They cannot establish a safety comparison unless an appropriate analysis and its results are reported, and a pharmacokinetic measure is not itself a measure of clinical benefit. The registry lists 10 outcome measures and 0 analyses. It does not report the statistical models, handling of repeated observations, covariate adjustment, multiplicity procedure, or missing-data method.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures, including safety, LY3031207 and simvastatin pharmacokinetics, and urinary metabolite outcomes. When multiple outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. General statistical practice may address this through prespecified outcome hierarchies, adjusted significance thresholds, or other multiplicity strategies. A multiplicity procedure or hierarchy is not reported in the registry record.
The record lists 0 analyses, and the primary outcome is not reduced to one comparison because it has several categories or time points. No primary-outcome test, estimate, or confidence interval is reported. It is therefore not possible to determine from the registry whether any planned comparisons were performed or how multiple comparisons were handled.
The primary analysis population is described as participants who received at least one dose of study drug. The enrollment is 39, but the record does not state how many randomized participants received a dose, how many were included in each outcome analysis, or how any missing observations were handled. Missing-data reasons, imputation, censoring, and sensitivity analyses are not reported in the registry record.
These omissions limit interpretation of both the safety counts and the other planned outcomes. The stated analysis population helps define who could contribute to the primary outcome, but it does not establish the analysis population for each secondary outcome. The record does not report whether outcome assessors used the same population or how participants with incomplete follow-up were treated.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo With or Without Simvastatin | 0 | 6 | 0.0% |
| 25 mg LY3031207 | 0 | 8 | 0.0% |
| 75 mg LY3031207 and Simvastatin | 0 | 10 | 0.0% |
| 225 mg LY3031207 and Simvastatin | 2 | 9 | 22.2% |
| 400 mg Celecoxib With or Without Simvastatin | 0 | 6 | 0.0% |
| 10 mg Simvastatin | 0 | 27 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo With or Without Simvastatin | 1 of 6 |
| 25 mg LY3031207 | 3 of 8 |
| 75 mg LY3031207 and Simvastatin | 5 of 10 |
| 225 mg LY3031207 and Simvastatin | 9 of 9 |
| 400 mg Celecoxib With or Without Simvastatin | 1 of 6 |
| 10 mg Simvastatin | 3 of 27 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo With or Without Simvastatin | 25 mg LY3031207 | 75 mg LY3031207 and Simvastatin | 225 mg LY3031207 and Simvastatin | 400 mg Celecoxib With or Without Simvastatin | 10 mg Simvastatin |
|---|---|---|---|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | 0 of 6 | 0 of 8 | 0 of 10 | 2 of 9 | 0 of 6 | 0 of 27 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo With or Without Simvastatin | 25 mg LY3031207 | 75 mg LY3031207 and Simvastatin | 225 mg LY3031207 and Simvastatin | 400 mg Celecoxib With or Without Simvastatin | 10 mg Simvastatin |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 0 of 6 | 1 of 8 | 1 of 10 | 4 of 9 | 0 of 6 | 1 of 27 |
| Nausea | Gastrointestinal disorders | 0 of 6 | 0 of 8 | 2 of 10 | 3 of 9 | 0 of 6 | 0 of 27 |
| Drug-induced liver injury | Hepatobiliary disorders | 0 of 6 | 0 of 8 | 1 of 10 | 3 of 9 | 0 of 6 | 0 of 27 |
| Diarrhoea | Gastrointestinal disorders | 0 of 6 | 1 of 8 | 0 of 10 | 2 of 9 | 0 of 6 | 0 of 27 |
| Fatigue | General disorders | 0 of 6 | 0 of 8 | 0 of 10 | 1 of 9 | 1 of 6 | 0 of 27 |
| Oral herpes | Infections and infestations | 0 of 6 | 0 of 8 | 0 of 10 | 2 of 9 | 0 of 6 | 0 of 27 |
| Viral upper respiratory tract infection | Infections and infestations | 0 of 6 | 1 of 8 | 1 of 10 | 0 of 9 | 0 of 6 | 0 of 27 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 6 | 0 of 8 | 1 of 10 | 1 of 9 | 0 of 6 | 0 of 27 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 6 | 0 of 8 | 0 of 10 | 1 of 9 | 0 of 6 | 1 of 27 |
| Dizziness | Nervous system disorders | 0 of 6 | 0 of 8 | 0 of 10 | 1 of 9 | 0 of 6 | 1 of 27 |
Serious events with the highest arm-level rate: drug-induced liver injury (22.2%).
The serious adverse-event figures are counts of affected participants alongside the number at risk in each listed group. The registry reports 2 serious-event participants among 9 at risk in the 225 mg LY3031207 and simvastatin group, and 0 serious-event participants in each of the other listed groups. These figures are descriptive. They do not by themselves show that a regimen caused an event or that groups differ statistically.
For other non-serious adverse events, the participant counts range across the groups, including 9 affected participants among 9 at risk in the 225 mg LY3031207 and simvastatin group. The registry states that the adverse-event summaries cover events regardless of causality. Accordingly, an event count should not be interpreted as a count of events judged to be caused by treatment.
The top serious adverse-event term is listed as drug-induced liver injury at 22.2%. The registry information does not give the denominator or context needed to interpret that percentage further. These event summaries also do not describe duration, recurrence, timing, or individual clinical course. The primary endpoint's specific drug-related-event component is not accompanied by a reported analysis, so the adverse-event counts should not be treated as a complete result for that endpoint.
12. What the Result Does, and Does Not, Mean
The registry describes a randomized, double-blind, parallel phase 1 study of repeated oral LY3031207 dosing in healthy participants, with placebo, celecoxib, and simvastatin-related groups. The posted adverse-event data give participant counts for serious and other non-serious events in the listed groups. They also identify drug-induced liver injury as the top serious adverse-event term at 22.2%.
Those observations are useful as a descriptive record of events reported during the study. They do not establish how frequently events would occur in a broader population, whether the events were caused by study treatment, or whether one group differs from another. The groups are small, no inferential comparisons or confidence intervals are reported, and the serious and other non-serious summaries are described as regardless of causality.
The record does not report analyzed primary-outcome results, nor numerical results for the registered pharmacokinetic and urinary metabolite outcomes. A study purpose or registered outcome indicates what investigators intended to assess; it is not evidence of a particular result. The record also does not report the reason the study was terminated, and that status alone does not establish why it ended or what the study found.
General statistical interpretation: conclusions depend on both the observed estimates and their uncertainty, as well as the methods and populations used to produce them. In this record, the available adverse-event counts are descriptive and the precision of comparative effects is not reported. They should not be converted into claims of benefit, harm, equivalence, or absence of risk.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a registered research question and an analyzed result. The registry specifies a safety endpoint and lists multiple pharmacokinetic and metabolite outcomes, but it reports 0 analyses and does not provide a primary-outcome comparison. For statistical interpretation, knowing what was planned is not the same as having estimates, uncertainty intervals, and methods with which to assess the results.
The study also highlights why outcome definitions matter. The primary endpoint title combines drug-related adverse events with any serious adverse events, while the adverse-event module summarizes serious and other non-serious events regardless of causality. A clear distinction between these concepts is essential when translating event counts into a treatment comparison.
Small groups and sparse serious-event counts are another important statistical feature. General statistical reasoning indicates that sparse data often produce uncertain estimates, even when the observed counts appear different. Without reported intervals or tests, descriptive differences should not be mistaken for precise evidence of group differences.
Finally, the study includes several treatment regimens and several types of outcome, including pharmacokinetics and safety. This makes transparent reporting of the analysis population, multiplicity handling, and missing-data methods especially relevant. Those details are not reported in the registry record. The study is therefore a useful example of how registry completeness and statistical reporting shape what readers can responsibly infer.
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 primary limitation is the absence of a reported analysis for the primary outcome. The registry identifies a composite safety endpoint, but the posted information does not provide a group comparison, estimate, confidence interval, or statistical test. The adverse-event counts are descriptive and are not clearly equivalent to the drug-related component of that endpoint.
The enrollment was 39, with group-specific at-risk counts ranging from 6 to 27 in the adverse-event summaries. These small group sizes limit the precision available from the observed event counts. The registry does not provide confidence intervals or other measures of uncertainty for those counts.
The record does not report the allocation ratio, detailed randomization or masking procedures, analysis methods, missing-data handling, multiplicity strategy, or the trial's original sample-size justification. Although an analysis population is defined for the primary outcome, the record does not give participant flow or outcome-specific analysis populations. These gaps make it difficult to assess how the reported group counts relate to all enrolled or randomized participants.
The study status is terminated, but the reason is not reported in the registry record. The available information also does not report numerical results for the listed pharmacokinetic and urinary metabolite outcomes. These limitations constrain interpretation to the descriptive information documented in the registry and do not support conclusions about comparative treatment effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Multiple-dose Study of LY3031207 in Healthy Participants — NCT01632566.
- Registry record last updated 2019-06-27; status last verified 2019-03.
- Results first posted 2019-06-27.
- 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.
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18. Record Summary
NCT01632566 is a randomized, double-blind, parallel phase 1 study of multiple-dose LY3031207 in healthy participants. The registry lists enrollment of 39, a study start in 2012-06, primary completion in 2013-04, and status as terminated. The termination reason is not reported in the registry record.
The primary outcome concerns participants with one or more drug-related adverse events or any serious adverse events. Adverse-event counts are reported for placebo, LY3031207 dose groups, celecoxib, and simvastatin-related groups. The registry also lists pharmacokinetic and urinary metabolite outcomes, but reports 0 analyses. No analyzed primary-outcome comparison or numerical results for those other outcomes are reported in the registry record.