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 LY3832479 (LY-CoV016) in Healthy Participants 1 (NCT04611789), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04611789 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 18 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy participants. The primary pharmacokinetic summaries apply to randomized participants who received study drug and had evaluable pharmacokinetic data; the registry reports 7 participants in each posted dose-group summary.
Intervention
Participants received a single subcutaneous dose of LY3832479 at 350 mg or 1000 mg. The study also included a single subcutaneous placebo dose.
Comparator
The study was randomized and placebo-controlled, and the active-dose groups provide summaries at two dose levels. The posted primary endpoint results contain values for the two LY3832479 dose groups, but not a placebo value for that endpoint.
Primary question
The primary endpoint asks how much LY3832479 exposure participants had over the measured period, using the area under the concentration-versus-time curve from time 0 to the last measured time. The registry describes the study's broader purpose as evaluating pharmacokinetics, safety, and tolerability after subcutaneous administration in healthy participants.
3. Trial Design
This was a randomized, placebo-controlled, participant- and investigator-blind Phase 1 study of LY3832479 in healthy participants. Its registered title identifies subcutaneous administration and evaluation of pharmacokinetics, safety, and tolerability. The study used a parallel-group design, with participants assigned to a single dose of 350 mg LY3832479, a single dose of 1000 mg LY3832479, or placebo.
The registry reports enrollment of 18 and lists the study as completed. The study began on 2020-11-02, and primary completion was recorded as 2021-02-10. Participation could last up to 16 weeks and could include up to six study-center visits, including a one-week overnight stay, according to the study summary.
The primary pharmacokinetic result is reported for participants who were randomized, received study drug, and had evaluable pharmacokinetic data. The posted summaries include 7 participants for each LY3832479 dose. The registry lists 4 participants at risk for the placebo safety summaries. These endpoint populations should not be treated as interchangeable: the registry does not establish that every randomized participant contributed data to every outcome.
The record lists two outcome measures and no posted secondary outcomes. It contains no posted analysis records. Details of the randomization procedure, allocation concealment, the planned sample-size justification, and any interim analyses 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.
Overall Study
| Stage | Placebo | 350 mg LY3832479 | 1000 mg LY3832479 |
|---|---|---|---|
| STARTED | 4 | 7 | 7 |
| COMPLETED | 3 | 7 | 7 |
| NOT COMPLETED | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Placebo | 350 mg LY3832479 | 1000 mg LY3832479 |
|---|---|---|---|
| Lost to Follow-up | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received study drug and had evaluable PK data.
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 randomized participants.
| Characteristic | Unit | Placebo | 350 mg LY3832479 | 1000 mg LY3832479 | Total |
|---|---|---|---|---|---|
| Participants analysed | 4 | 7 | 7 | 18 | |
| Age, Continuous | Years | 33.8 (SD 10.4) | 49.0 (SD 12.4) | 42.7 (SD 13.3) | 43.2 (SD 13.1) |
| Sex: Female, Male: Female | Participants | 0 | 4 | 3 | 7 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 4 | 11 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 2 | 4 | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 5 | 3 | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 4 | 4 | 6 | 14 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 4 | 7 | 7 | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479, measured over Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | microgram*day per milliliter (μg*day/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the concentration-versus-time curve from time 0 to the last measured time, abbreviated AUC[0-tlast]. It summarizes measured drug concentration across the observation period, rather than describing concentration at just one sampling time. The registry reports the endpoint in microgram*day per milliliter (μg*day/mL), with pharmacokinetic measurements scheduled on Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose.
AUC is used in pharmacokinetic studies to characterize drug exposure over time. The registry reports a geometric mean for each dose group, alongside a geometric coefficient of variation. These summaries describe the distribution of exposure values on a multiplicative scale, which can be useful when measurements are positively skewed. They do not, by themselves, show how individuals' concentrations changed at each visit, or establish a causal contrast between doses.
The posted primary values are 1560.0 for 350 mg and 4530.0 for 1000 mg. A placebo value for this endpoint is not reported in the registry record. Confidence intervals, individual participant data, and a formal between-group analysis are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports geometric mean AUC[0-tlast] values of 1560.0 μg*day/mL for the 350 mg LY3832479 group and 4530.0 μg*day/mL for the 1000 mg group. The corresponding geometric coefficients of variation are 80.0% and 31.0%. Each posted pharmacokinetic summary includes 7 participants. These are descriptive group summaries, not estimates accompanied by a reported confidence interval or a formal test of the difference between doses.
The two geometric means describe the observed exposure summaries at the two dose levels. They do not establish that exposure changes in direct proportion to dose, nor do they establish the size or precision of a dose contrast. No dose-comparison estimate, p-value, or confidence interval is reported in the registry record. The primary endpoint table therefore supports a description of the posted values, but not an inferential conclusion about the population-level difference between dose groups.
The geometric coefficient of variation indicates relative variability in the measurements on a multiplicative scale. The posted value is higher in the 350 mg group than in the 1000 mg group, but the summaries alone do not show why. With 7 participants in each reported group, the observed spread may be sensitive to individual values. Participant-level data and uncertainty intervals are not reported in the registry record, so the precision of these variability estimates cannot be assessed from the posted summaries.
The registry also posts safety counts. There were no serious adverse events reported in the placebo group or either active-dose group, and no deaths were reported. One participant in the 1000 mg group was recorded as affected by an other, non-serious adverse event; none were recorded in the placebo or 350 mg groups. These counts are descriptive. The record does not provide event terms or a formal safety comparison, so the counts do not establish whether an event was caused by treatment or how rates might differ in a larger population.
Overall, the posted data describe pharmacokinetic exposure summaries in two small active-dose groups and adverse-event counts across the study groups. They do not provide a comparative inferential analysis, and they do not establish the results that would be expected in populations or settings beyond this study.
9. Statistical Methods Explained
The registry presents the primary pharmacokinetic endpoint as a geometric mean and reports geometric coefficients of variation. These are descriptive summaries. The record does not post an inferential model or a formal test comparing the dose groups, so interpretation should stay with the values and variability summaries actually reported.
What the geometric mean summarizes
In general, a geometric mean summarizes measurements on a multiplicative rather than an additive scale. It is calculated from logarithms of the observed values and then expressed back on the original scale. This approach is often useful for pharmacokinetic quantities, which can vary proportionally and may have a right-skewed distribution. A geometric mean is not the same as an arithmetic average, and it does not describe the full range of participant values.
The posted geometric means are 1560.0 μg*day/mL for 350 mg and 4530.0 μg*day/mL for 1000 mg. The registry does not report individual values, confidence intervals, or a statistical comparison for these summaries. As a result, the values can be described as the reported group summaries, but their uncertainty and the strength of evidence for a difference cannot be quantified from the record.
What the geometric coefficient of variation conveys
In general, a coefficient of variation expresses variability relative to a central value. A geometric coefficient of variation is appropriate to data analyzed on a logarithmic scale and describes multiplicative dispersion. It is not a confidence interval and does not show the precision of the estimated geometric mean. A larger value indicates greater relative spread under this summary, while a smaller value indicates less relative spread.
The registry reports geometric coefficients of variation of 80.0% for 350 mg and 31.0% for 1000 mg. These figures describe the observed variability summaries; they do not explain its cause. With 7 participants in each group, they should not be taken as stable estimates of variability in a broader population without further evidence.
Why the endpoint is exposure over time
In general, AUC integrates concentration over a stated time interval and captures cumulative measured exposure during that interval. AUC[0-tlast] ends at the last measured time rather than extending to an unobserved endpoint. Its interpretation therefore depends on the sampling schedule and the measured concentrations. The registry lists measurements from Day 1 through Day 85 postdose at specified visits. The posted endpoint is not a direct measure of clinical benefit, and the registry does not report a clinical efficacy outcome.
What planning illustrations can and cannot show
In general, sample-size planning illustrations estimate how many participants per arm might be needed to detect a specified effect under stated assumptions. They are not observed trial results and are not observed power. The planning assumptions described for the illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is defined as a stated fraction of the observed effect. Such illustrations depend on those assumptions and on the chosen effect size. They do not establish the original design rationale for this trial, which is not reported in the registry record.
The record does not state that a formal analysis was conducted using these planning assumptions. Nor does it report a prespecified comparison or an inferential result for the posted AUC summaries. The displayed endpoint values and the planning illustrations therefore answer different questions: one describes the observed data, while the other illustrates sample-size implications under assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures, but it reports no posted secondary outcomes and no posted analysis records. The primary endpoint is AUC[0-tlast]. Whether the study protocol included additional planned endpoints or analyses beyond the posted record is not reported in the registry record.
Multiplicity arises when several outcomes, time points, doses, or statistical tests are considered. In general, conducting many tests can increase the chance of obtaining a nominally unusual result by chance; prespecified methods can account for that issue. The registry does not report a multiplicity strategy, a hierarchy of hypotheses, or which comparisons were planned. No inferential results are posted for the primary endpoint, so there is no reported set of p-values to interpret for multiplicity.
The primary pharmacokinetic population is described as all randomized participants who received study drug and had evaluable pharmacokinetic data. The posted dose-group summaries each include 7 participants. The record does not report how many randomized participants lacked evaluable pharmacokinetic data, why data may have been unavailable, or how missing measurements were handled. It also does not describe imputation, sensitivity analyses, or rules for excluding observations.
The analysis population used for the safety counts is represented by participants at risk in each group, but the registry does not provide a fuller account of safety-analysis conventions. Details of the statistical analysis plan, including model specifications and adjustment for covariates, are not reported in the registry record. Without those details, the reported summaries should be read as posted descriptive results rather than as a complete account of the planned or conducted analysis.
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 SC | 0 | 4 | 0.0% |
| 350 mg LY3832479 SC | 0 | 7 | 0.0% |
| 1000 mg LY3832479 SC | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo SC | 0 of 4 |
| 350 mg LY3832479 SC | 0 of 7 |
| 1000 mg LY3832479 SC | 0 of 7 |
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 SC | 0 of 4 |
| 350 mg LY3832479 SC | 0 of 7 |
| 1000 mg LY3832479 SC | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo SC | 350 mg LY3832479 SC | 1000 mg LY3832479 SC |
|---|---|---|---|---|
| Injection site reaction | General disorders | 0 of 4 | 0 of 7 | 1 of 7 |
The safety record lists serious adverse events, other adverse events, and deaths by group. No serious adverse events were reported among the 4 placebo participants at risk, the 7 participants at risk in the 350 mg LY3832479 group, or the 7 participants at risk in the 1000 mg group. No deaths were reported in any of these groups.
For other adverse events, the record reports no affected participants in the placebo group or 350 mg group, and 1 affected participant in the 1000 mg group. These are counts, not evidence of causation. The registry does not report the term for that event, its severity, timing, duration, or relationship to study drug. The record also does not provide a formal comparison between groups.
Zero serious events in a small study does not establish that serious events cannot occur. These counts describe only the participants included in the posted safety summaries and are not a precise estimate of the frequency of uncommon events in a larger population. The registry record does not provide confidence intervals for the safety counts.
12. What the Result Does, and Does Not, Mean
The posted results provide descriptive pharmacokinetic exposure summaries after single subcutaneous doses of 350 mg and 1000 mg LY3832479 in healthy participants. The geometric mean AUC[0-tlast] values are 1560.0 and 4530.0 μg*day/mL, respectively, with geometric coefficients of variation of 80.0% and 31.0%. The registry also records no serious adverse events or deaths in the listed groups and one other adverse event in the 1000 mg group.
These findings do not establish a formal difference between dose groups. No estimate of the between-group contrast, confidence interval, or p-value is reported in the registry record. The geometric means are not evidence that dose and exposure have a particular mathematical relationship, and the variability summaries do not explain participant-level patterns.
The study's stated purpose included evaluating safety and tolerability, but the posted counts alone do not provide a full account of tolerability. The event term and further details for the one other adverse event are not reported in the registry record. Absence of serious adverse events in this study does not show that such events are impossible or predict their frequency in other groups.
The results are specific to a Phase 1 study in healthy participants after single subcutaneous doses. The record does not report a clinical efficacy endpoint or support conclusions about clinical benefit. It also does not establish what would happen with repeated dosing or in populations other than those studied. The main statistical reading is therefore descriptive: the registry gives exposure summaries and observed safety counts, while important elements needed for broader or comparative conclusions are not reported.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between descriptive pharmacokinetic results and a comparative statistical analysis. A geometric mean gives a concise summary of exposure in a group, while the geometric coefficient of variation describes relative dispersion. Neither quantity, on its own, provides an uncertainty interval or a test of whether two groups differ. The registry's dose-group values can therefore be read as summaries of observed data, not as a complete inferential comparison.
The record also shows why the analysis population matters. The primary endpoint applies to randomized participants who received study drug and had evaluable pharmacokinetic data, and the posted summaries include 7 participants per active-dose group. The total enrollment is 18, but enrollment alone does not determine how many participants contribute to a particular endpoint. Reading endpoint-specific populations avoids treating all trial participants as if they necessarily had complete data for every measure.
For safety, counts of zero serious adverse events are useful descriptions of what was recorded in this study, but small group counts cannot characterize rare-event risk precisely. The one other adverse event in the 1000 mg group is also a descriptive count; without an event term or relationship assessment, it cannot be interpreted as a treatment effect.
Finally, the record distinguishes what is reported from what remains unknown. It gives the endpoint definition, summary statistics, and safety counts, but not a formal comparative analysis, confidence intervals, or detailed missing-data methods. That separation is important in early-phase research: a clear account of observed pharmacokinetics is valuable, while the limits of precision and inference must remain explicit.
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 posted primary endpoint results cover the two LY3832479 dose groups, but a placebo AUC value is not reported in the registry record. The summaries are geometric means with geometric coefficients of variation; confidence intervals, individual participant values, and formal dose comparisons are not reported. This limits assessment of both uncertainty and the extent to which participants' results varied within each group.
The primary endpoint population requires receipt of study drug and evaluable pharmacokinetic data. The registry does not report whether any participants were excluded from that population, whether any scheduled measurements were missing, or how incomplete concentration profiles were handled. Details of the randomization process, allocation concealment, and statistical analysis plan are also not reported in the registry record.
The safety summaries include 4 participants at risk in the placebo group and 7 in each active-dose group. No serious adverse events or deaths were recorded, and one other adverse event was recorded in the 1000 mg group. The registry does not report that event's term, timing, severity, or assessed relationship to study drug. The small groups and absence of uncertainty estimates constrain interpretation of safety frequencies.
The study enrolled healthy participants and evaluated single subcutaneous doses. Its findings should not be taken as evidence about repeated dosing, other populations, or clinical efficacy. The registry does not report the trial's sample-size justification, interim analyses, or planned multiplicity approach. These omissions prevent a full reconstruction of the design and analysis decisions from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of LY3832479 (LY-CoV016) in Healthy Participants 1 — NCT04611789.
- Registry record last updated 2021-12-06; status last verified 2021-11.
- Results first posted 2021-12-06.
- 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
NCT04611789 is a completed randomized, placebo-controlled, participant- and investigator-blind Phase 1 study of subcutaneous LY3832479 in healthy participants. Enrollment was 18. The study began on 2020-11-02, and primary completion was recorded as 2021-02-10.
Participants received a single dose of 350 mg LY3832479, 1000 mg LY3832479, or placebo. The primary endpoint was AUC[0-tlast], summarized as a geometric mean with a geometric coefficient of variation. The posted active-dose summaries each include 7 participants. The record lists two outcome measures, no posted secondary outcomes, and no posted analysis records.
No serious adverse events or deaths were recorded in the posted safety groups; one other adverse event was recorded in the 1000 mg group. The registry does not report a formal comparative analysis for the primary endpoint or further details about that event.