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 LY3113593 in Participants With Chronic Kidney Disease (NCT02604160), a randomized phase 1 study. The primary outcome is Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02604160 |
| Phase | Phase 1 |
| Condition | Chronic Kidney Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with chronic kidney disease receiving hemodialysis were eligible for this study. The registry record reports an enrollment of 7. The primary safety population was defined as participants who received at least one dose of study drug or placebo and had at least one post-dose safety assessment. The number in each treatment group differs: the posted primary endpoint figures include 2 participants in the placebo group and 5 in the LY3113593 group.
Intervention
The intervention was LY3113593, administered by intravenous infusion. In part A, the arm description specifies escalating doses once every 4 weeks on Day 1 and Day 29. The study summary says participants could receive up to four injections and could enroll in only one of up to three parts. The specific dose levels and the number of participants enrolled in each part are not reported in the registry record.
Comparator
The comparator was placebo, described as 0.9% saline administered by intravenous infusion once every 4 weeks on Day 1 and Day 29 in part A. The study was randomized, single-masked, and used a parallel design. The registry record does not describe the masking procedures or report the allocation method beyond identifying the study as randomized.
Primary question
The primary safety question was how many participants had one or more serious adverse events that the investigator considered related to study drug administration, from baseline through Day 29. The registry reports 1 such participant in the LY3113593 group and 0 in the placebo group. The endpoint is a count of participants, not a measure of how often events occurred or how severe they were. The result describes this small study’s posted safety observations; it does not establish a treatment effect.
3. Trial Design
This was a completed Phase 1, randomized, single-masked, parallel study of LY3113593 in participants with chronic kidney disease receiving hemodialysis. The registry lists an enrollment of 7. The study began on 2015-11-17, and primary completion was 2016-06-22. The registry record identifies Eli Lilly and Company as the sponsor.
The study summary describes up to three parts, with each participant enrolled in only one part. Participants could receive up to four intravenous injections of LY3113593 or placebo, and the overall study duration was described as up to about 26 weeks, including screening and follow-up. The arm descriptions give the schedule for part A: escalating doses of LY3113593 or 0.9% saline placebo, administered once every 4 weeks on Day 1 and Day 29. The dose levels and the design details for parts beyond part A are not reported in the registry record.
The primary outcome was a safety count: participants with one or more serious adverse events considered by the investigator to be related to study drug administration, assessed from baseline through Day 29. The analysis population was defined as participants who received at least one dose and had at least one post-dose safety assessment. The posted figures show 2 participants in the placebo group and 5 in the LY3113593 group.
The listed secondary outcomes concern pharmacokinetics, pharmacodynamics, and antibodies: maximum drug concentration, area under the concentration-versus-time curve, change from baseline to Week 8 in hemoglobin, and detection of anti-LY3113593 antibodies. The registry record does not report the detailed statistical plan, the randomization procedure, the masking procedures, or a sample-size justification. Those omissions limit what can be inferred about the study’s planned analyses and design rationale.
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: In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
Overall Study
| Stage | Placebo | LY3113593 |
|---|---|---|
| STARTED | 2 | 5 |
| Received at Least One Dose of Study Drug | 2 | 5 |
| COMPLETED | 2 | 3 |
| NOT COMPLETED | 0 | 2 |
Reasons for not completing this period:
| Reason | Placebo | LY3113593 |
|---|---|---|
| Protocol Violation | 0 | 1 |
| Physician Decision | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment.
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 | Placebo | LY3113593 | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 5 | 7 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 0 | 2 | 2 |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 2 | 5 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, measured over Baseline through Day 29.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with one or more serious adverse events that the investigator considered related to study drug administration. Its timeframe is baseline through Day 29. A participant is counted if at least one qualifying serious event occurred; multiple qualifying events in the same participant do not turn the endpoint into a count of events. The endpoint therefore describes the number of affected participants in each arm, rather than the total number of serious events.
A safety endpoint of this kind is used to organize observations about serious harms during a defined period after treatment begins. It focuses on events classified as serious and judged by the investigator to be related to study drug administration. The registry also notes that summaries of other non-serious adverse events and all serious adverse events, regardless of causality, are located in the reported adverse events section. Those broader categories are not identical to the primary endpoint, which applies both a seriousness criterion and an investigator-assessed relationship criterion.
The posted primary result is 1 participant in the LY3113593 group and 0 in the placebo group. These counts describe what was observed during the stated timeframe in the analyzed safety population. They do not by themselves quantify the probability of an event in a broader population, establish whether groups differ, or describe the clinical details of the event. A formal estimate of comparative uncertainty is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 1 participant with one or more serious adverse events considered related to study drug administration in the LY3113593 group, compared with 0 in the placebo group, from baseline through Day 29. The corresponding group sizes for this endpoint are 5 and 2. These are small counts from a study with an enrollment of 7, so the observed result is a description of the participants enrolled rather than a precise estimate of what might occur in a larger population.
The endpoint counts participants, not events. It cannot show from the count alone whether the participant experienced one qualifying event or more than one. Nor does the primary result give event severity beyond the serious classification, timing within the follow-up period, clinical course, or the investigator’s reasoning about relatedness. These details are not reported in the registry record for this endpoint.
The result should also be kept distinct from the registry’s broader adverse-event figures. The posted adverse-event summary lists other adverse events affecting 2 of 2 participants in the placebo group and 5 of 5 in the LY3113593 group. It also lists a serious adverse-event term, “Cardiac failure congestive,” at 20.0%. The term listing does not establish that the event was considered related to study drug; the primary endpoint uses an investigator-assessed relatedness criterion, while the broader serious-event summary includes serious events regardless of causality. The registry record does not provide enough detail in the stated details to connect that term to the primary endpoint result.
No comparative test or interval estimate for the binary primary endpoint is reported in the registry record. The registry record also indicates that values were missing or not estimable for a two-arm comparison. Without a reported comparative estimate and its uncertainty, the counts should not be read as evidence of a reliable difference between treatments. With so few participants, a count changing by one would have a substantial effect on the visible pattern, but no new numerical comparison should be inferred from that observation.
The study’s stated purpose was to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, rather than to treat anemia of chronic kidney disease. The posted primary result is therefore best read as an early safety observation within this study’s limited follow-up and population. It is not a conclusion about longer-term safety, efficacy, or outcomes in other groups.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: each participant either met the endpoint definition or did not. The registry reports the number meeting the definition in each arm, along with the number of participants in the endpoint population. For this endpoint, 1 of the 5 participants in the LY3113593 group and 0 of the 2 participants in the placebo group met the definition. These are descriptive counts. The registry record does not report a formal comparative estimate, confidence interval, or hypothesis test for this endpoint.
What does a participant count tell us?
A participant count answers how many people experienced at least one event meeting the endpoint definition. It does not measure the total burden of events if a person could have multiple events, and it does not preserve information about event timing or duration. Counts are straightforward to interpret, but the amount of information they contain depends on how many participants were observed. When group sizes are small, each participant represents a substantial part of the observed group, so the count can be unstable as an estimate for a wider population.
A comparative analysis of a binary outcome can be expressed in several ways, such as a difference in event proportions, a relative measure, or a model-based estimate. Each approach has assumptions and conveys a different aspect of the comparison. None should be substituted for the posted result unless it is reported or explicitly calculated as a recalculation. The registry record says values were missing or not estimable for a two-arm comparison, and there are no posted analyses. Accordingly, the result should remain a description of the observed counts rather than be presented as a comparative effect.
Why does uncertainty matter?
A confidence interval is a range of values compatible with the data under a specified statistical method. It communicates the uncertainty around an estimate; it is not a guarantee that the true value lies in the interval. With sparse binary data, uncertainty can be substantial, and different methods can behave differently. No confidence interval is reported for the primary comparison in the registry record, so its precision cannot be summarized with an interval from the posted information.
A significance test would assess how compatible the observed data are with a specified null hypothesis under a particular model. A p-value would not measure the probability that a treatment works, nor would it describe the magnitude or clinical importance of a result. No p-value or test for this primary comparison is reported in the registry record. It would be inappropriate to infer statistical significance or its absence from the raw counts alone.
How should the adverse-event categories be separated?
The primary endpoint concerns serious adverse events that the investigator considered related to study drug administration. The registry separately notes that other non-serious adverse events and all serious adverse events, regardless of causality, are summarized in the adverse events section. These definitions answer different questions. A serious event can be included in an all-causality summary without meeting the primary endpoint’s relatedness criterion. Likewise, an event term listed in the adverse-event information cannot automatically be treated as a primary endpoint event.
The posted adverse-event information lists “Cardiac failure congestive” at 20.0% among the top serious terms. That label is a registry-listed term and percentage; it is not, on its own, an adjudication of causality or a complete clinical account. The registry record does not report the relationship between that term and the primary endpoint in the registry record stated for this analysis. The reported group-level counts of other adverse events also do not establish event severity or causal attribution.
What can the design support?
Randomization is intended to allocate participants to treatment groups by chance, helping make groups comparable in expectation. It does not ensure that groups will be balanced in a small study. The posted endpoint population contains 2 placebo participants and 5 LY3113593 participants. Single masking indicates that the study is described as single-masked, but who was masked and how masking was maintained are not reported in the registry record. A parallel design means the treatment groups are followed as distinct groups; it does not itself determine which statistical model was used.
The registry identifies the study as Phase 1 and describes its aims as evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. It does not report a statistical analysis plan, interim analysis plan, or justification for the planned enrollment. A sample-size justification is not reported in the registry record. Sample-size calculations based on observed effects are planning illustrations, not observed power and not evidence that the study was designed to detect a particular effect. The stated planning framework uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect expressed as a fraction of the observed effect. Those assumptions describe the illustration, not the trial’s reported design rationale.
The listed secondary outcomes include pharmacokinetic measures, a hemoglobin change measure, and antibody detection. These outcomes use different data types and may call for methods unlike a participant-level binary count. The registry record lists four secondary outcomes but reports no analyses for them in the registry record. Their numerical results and analysis methods are not reported in the registry record.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Placebo | 2 | 0 | 0.0% | 0.0% to 84.2% | 0.0% to 65.8% | 0.8% to 70.8% |
| LY3113593 | 5 | 1 | 20.0% | 0.5% to 71.6% | 3.6% to 62.4% | 4.3% to 64.1% |
R code and output
arm <- c("Placebo", "LY3113593")
n <- c(2, 5)
events <- c(0, 1)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Placebo 2 0 0.0 0.0 84.2 0.0 65.8 0.8 70.8
ARM LY3113593 5 1 20.0 0.5 71.6 3.6 62.4 4.3 64.111. Multiplicity, Missing Data and Analysis Populations
The registry lists four secondary outcomes in addition to the primary safety endpoint: maximum drug concentration, area under the concentration-versus-time curve, change from baseline to Week 8 in hemoglobin, and detection of anti-LY3113593 antibodies. These outcomes address different questions and may involve distinct analysis methods. The registry record does not report whether the study adjusted for multiple comparisons, set a hierarchy among outcomes, or treated the secondary findings as exploratory. Without such information, a reader cannot determine how the overall chance of false-positive findings was managed across outcomes.
No analyses are listed for the posted outcomes, and the numerical results for the secondary outcomes are not reported in the registry record. The primary binary comparison is described as missing or not estimable. The registry record does not explain the reason for that status beyond the stated lack of estimable values for a two-arm comparison. It also does not report how missing outcome data were handled, whether any participants were excluded from particular outcome analyses, or whether sensitivity analyses were conducted.
The primary safety population is defined as participants who received at least one dose and had at least one post-dose safety assessment. This definition clarifies who was included for that endpoint, but does not provide the numbers screened, randomized, treated, or excluded, or the reasons for any exclusions. Details of analysis populations for the secondary outcomes are not reported in the registry record. The registry record also does not report an intention-to-treat analysis or an approach to missing data for the listed secondary measures.
12. 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 | 0 | 2 | 0.0% |
| LY3113593 | 1 | 5 | 20.0% |
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 | 2 of 2 |
| LY3113593 | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | LY3113593 |
|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | 0 of 2 | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | LY3113593 |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 2 of 2 | 4 of 5 |
| Hyperparathyroidism secondary | Endocrine disorders | 0 of 2 | 1 of 5 |
| Diarrhoea | Gastrointestinal disorders | 0 of 2 | 1 of 5 |
| Influenza | Infections and infestations | 1 of 2 | 0 of 5 |
| Sinusitis | Infections and infestations | 0 of 2 | 1 of 5 |
| C-reactive protein increased | Investigations | 0 of 2 | 1 of 5 |
| Hypercalcaemia | Metabolism and nutrition disorders | 0 of 2 | 1 of 5 |
| Hypocalcaemia | Metabolism and nutrition disorders | 0 of 2 | 1 of 5 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 2 | 1 of 5 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 0 of 2 | 1 of 5 |
Serious events with the highest arm-level rate: cardiac failure congestive (20.0%).
For the primary safety endpoint, the posted result is 1 participant in the LY3113593 group and 0 in the placebo group with one or more serious adverse events considered related to study drug administration. The reported endpoint population sizes are 5 and 2, respectively. The timeframe is baseline through Day 29. These are participant counts under a specific definition, not a comprehensive measure of all adverse events.
The broader adverse-event figures list other adverse events for 2 of 2 placebo participants and 5 of 5 LY3113593 participants. The registry also lists “Cardiac failure congestive” at 20.0% among the top serious terms. The serious-term listing should not be assumed to represent an event judged related to study drug: the primary endpoint includes an investigator-assessed relatedness condition, whereas the broader serious-event summary includes events regardless of causality. The registry record does not report the clinical details needed to reconcile the term listing with the primary endpoint.
Death counts are not reported in the registry record. The small group sizes and short primary endpoint timeframe limit how much can be concluded from these observations. The figures describe events recorded in this study; they do not establish the frequency of events in a broader population or resolve uncertainty about longer-term safety.
13. What the Result Does, and Does Not, Mean
The result establishes what the registry reports for the primary safety endpoint in this study: 1 participant in the LY3113593 group and 0 in the placebo group had one or more serious adverse events considered related to study drug administration during baseline through Day 29. It also makes clear that the endpoint was defined for participants who had received at least one dose and had at least one post-dose safety assessment. The observed group sizes were 5 and 2.
Those figures do not provide a precise estimate of the risk of an event outside this study. The groups are small, and the registry record reports no confidence interval, test, or estimable two-arm comparison. The result should therefore not be interpreted as establishing either a treatment difference or equivalence. A zero count in one group does not demonstrate that an event cannot occur, and a count in the other group does not establish that treatment caused it.
The endpoint also captures only serious events judged by the investigator to be related to study drug administration. It does not summarize all adverse events, all serious events regardless of cause, or their clinical course. The registry record separately reports other adverse-event counts and a serious-event term, but those summaries have different definitions. They should not be merged into the primary endpoint without participant-level detail and a clear relationship assessment.
The study’s stated aims include evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. It was not intended to treat anemia of chronic kidney disease, according to the study summary. The listed secondary outcomes concern drug concentration, exposure over time, hemoglobin change, and antibody detection, but their numerical results are not reported in the registry record. Thus, the primary safety count does not answer whether LY3113593 changes hemoglobin, how the drug behaves in the body, or whether it has a treatment benefit.
More broadly, the result is an early, limited observation in a Phase 1 study of participants receiving hemodialysis. The record does not establish longer-term safety, effects in other populations, or clinical effectiveness. Interpretation should remain tied to the enrolled participants, the stated endpoint definition, and the reported follow-up timeframe.
14. Why This Trial Matters Statistically
This trial illustrates why early safety results need to be read in relation to their endpoint definition, population, and precision. A count of participants with an investigator-related serious adverse event is narrower than a summary of all adverse events or all serious events. Keeping these definitions separate prevents a broad event listing from being mistaken for the primary outcome or for a causal conclusion.
The randomized, parallel design provides a framework for comparing treatment groups, but random allocation cannot eliminate uncertainty when only 7 participants are enrolled. The primary endpoint population includes 5 participants receiving LY3113593 and 2 receiving placebo. With such small groups, the posted counts are informative as observations from the enrolled participants, but they offer limited precision for generalizing to a wider population. The registry record does not report an estimable two-arm comparison or a statistical test that would quantify that uncertainty.
The listed secondary outcomes also show how a Phase 1 study can address more than one type of question. Pharmacokinetic measures concern drug concentration and exposure; pharmacodynamic assessment includes change in hemoglobin; antibody detection concerns immune response to the study drug. Different outcomes need different analysis strategies, and a multiplicity plan can affect how several results are interpreted together. Those statistical details and the secondary numerical results are not reported in the registry record.
Finally, this record underscores the distinction between a study’s purpose and what its results can establish. The stated goal was evaluation of safety, tolerability, pharmacokinetics, and pharmacodynamics, not treatment of anemia of chronic kidney disease. The primary result is consequently a bounded safety observation, not a test of clinical benefit. Transparent reporting of event definitions, analysis populations, missing data, and uncertainty is essential for readers to judge what a small early-phase study does and does not contribute.
15. 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 for interpreting the primary result is the small endpoint population: 5 participants in the LY3113593 group and 2 in the placebo group. The result is reported as counts, with no confidence interval or statistical test for the two-arm comparison. The registry record states that values were missing or not estimable for such a comparison, so comparative precision cannot be assessed from the posted result.
The primary endpoint applies only to serious adverse events considered related to study drug administration and covers baseline through Day 29. It does not represent every adverse event during the full study duration, which the summary describes as up to about 26 weeks including screening and follow-up. The record also describes up to three study parts, but the dosing and design details for parts beyond part A are not reported in the registry record. The number of participants in each part and the dose levels are not reported.
Additional limitations concern reporting detail. The registry record does not report the statistical analysis plan, sample-size justification, interim analyses, method for randomization, or who was masked. It does not give the rationale for the missing or non-estimable comparison, details of missing-data handling, or numerical secondary outcome results. The serious-event term listing does not provide enough information to determine its relationship to the primary endpoint. Death counts are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study of LY3113593 in Participants With Chronic Kidney Disease — NCT02604160.
- Registry record last updated 2019-03-21; status last verified 2018-08.
- Results first posted 2019-03-21.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT02604160 is a completed Phase 1 randomized, single-masked, parallel study of LY3113593 in participants with chronic kidney disease receiving hemodialysis. The registry lists an enrollment of 7 and identifies Eli Lilly and Company as sponsor. The study summary describes up to three parts, with up to four intravenous injections of LY3113593 or placebo and a study duration of up to about 26 weeks including screening and follow-up. Part A arm descriptions specify administrations on Day 1 and Day 29.
The primary endpoint was the number of participants with one or more serious adverse events considered related to study drug administration from baseline through Day 29. The posted counts are 1 of 5 for LY3113593 and 0 of 2 for placebo. The registry lists four secondary outcomes, but their numerical results and analyses are not reported in the registry record. A comparative analysis for the primary endpoint is not estimable in the posted information.