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 Galcanezumab (LY2951742) in Healthy Chinese Participants (NCT04085289), a randomized phase 1 study. The primary outcome is Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04085289 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 30 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy Chinese participants. The registry lists total enrollment as 30. The primary endpoint population is described as all randomized participants who received at least one dose of galcanezumab. The posted arm counts are 12 participants for each galcanezumab dose group and 6 for placebo.
Intervention
Participants assigned to galcanezumab received a single subcutaneous dose of either 120 mg or 240 mg. The study assessed pharmacokinetics, safety, and tolerability after dosing. The registry describes the study duration as up to about 24 weeks.
Comparator
The comparator was a single subcutaneous dose of placebo. The study used randomized allocation, double masking, and a parallel-group model. The posted primary endpoint values are for the two galcanezumab groups; no placebo value is posted for this pharmacokinetic endpoint.
Primary question
The primary question was what maximum concentration of galcanezumab was observed in blood after dosing. The registry reports geometric mean Cmax values of 12.6 μg/mL for 120 mg and 27.2 μg/mL for 240 mg. It also reports a geometric coefficient of variation of 23.0 for each group. No confidence intervals, p-values, or formal comparison of these dose groups are posted. The study also collected information about side effects.
3. Trial Design
This was a phase 1, randomized, double-masked, parallel-group study of galcanezumab in healthy Chinese participants. The registry lists total enrollment as 30 and describes three groups: placebo, 120 mg galcanezumab, and 240 mg galcanezumab. Both active-treatment groups received a single subcutaneous dose; the placebo group received a single subcutaneous dose of placebo. The posted counts are 12 participants in each active-treatment group and 6 in the placebo group.
The study was registered as completed. The recorded start date is 2019-11-20, and the primary completion date is 2020-05-21. The study summary describes participation as lasting up to about 24 weeks. These details establish the broad setting and dosing structure, but they do not explain how randomization was generated, how treatment masking was maintained, or what visit and blood-sampling procedures were used. Those details are not reported in the registry record.
The stated purpose was to assess how quickly galcanezumab enters the bloodstream and how long it takes the body to remove it, while also collecting side-effect information. The primary posted outcome is maximum concentration, or Cmax, for galcanezumab. The registry gives geometric means and geometric coefficients of variation for the two active-dose groups. It does not post a placebo Cmax value or an inferential comparison between active doses.
The registry record does not describe a sample-size justification, the randomization ratio as a protocol decision, or any interim analysis. Although enrollment and arm counts are available, those counts alone do not establish what the study was designed to detect. The study is therefore best read as a small, early-phase pharmacokinetic and safety assessment, with the posted numerical result focused on descriptive concentration summaries.
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 | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|
| STARTED | 6 | 12 | 12 |
| Received at Least One Dose of Study Drug | 6 | 12 | 12 |
| COMPLETED | 6 | 12 | 11 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least one dose of Galcanezumab.
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 who received at least one dose of study drug.
| Characteristic | Unit | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC | Total |
|---|---|---|---|---|---|
| Participants analysed | 6 | 12 | 12 | 30 | |
| Age, Continuous | years | 26.70 (SD 4.18) | 26.80 (SD 6.03) | 28.80 (SD 4.09) | 27.60 (SD 4.91) |
| Sex: Female, Male: Female | Participants | 2 | 4 | 1 | 7 |
| Sex: Female, Male: Male | Participants | 4 | 8 | 11 | 23 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 12 | 12 | 30 |
| 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 | 6 | 12 | 12 | 30 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: China | Participants | 6 | 12 | 12 | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab, measured over 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | micrograms per milliliter (μg/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum concentration of galcanezumab, Cmax, measured in micrograms per milliliter (μg/mL). Cmax describes the highest concentration reached in the blood after a dose, making it a pharmacokinetic measure of systemic exposure. It addresses part of the study’s stated aim of characterizing how galcanezumab enters the bloodstream. It does not, by itself, describe how long the drug remains in the body; the posted primary outcome is not a measure of removal or elimination.
The registry reports the endpoint as a geometric mean with a geometric coefficient of variation. In general, a geometric mean is a way to summarize positive measurements when values are better described on a multiplicative than an additive scale. The coefficient of variation describes relative variability around the group summary. These are descriptive summaries; without interval estimates or a formal comparison, they do not indicate the precision of a difference between doses.
The outcome timeframe lists post-dose times from 8 hours through 3360 hours. The registry does not explain the exact derivation of each participant’s Cmax, the handling of concentrations below assay limits, or the analysis method used to summarize the measurements. Those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted geometric mean Cmax is 12.6 μg/mL in the 120 mg galcanezumab group and 27.2 μg/mL in the 240 mg group. The corresponding geometric coefficient of variation is 23.0 for each group. These values describe the recorded pharmacokinetic summaries among participants in the two active-treatment groups. The registry does not post a placebo Cmax result, a confidence interval, a p-value, or a formal statistical test comparing doses.
The higher dose group has the higher listed geometric mean Cmax. That descriptive ordering is not equivalent to a statistical demonstration of a dose difference. The posted summaries do not quantify uncertainty around either mean or around a contrast between the groups. The record also does not say whether an adjusted comparison was conducted. No inferential analysis is listed, so the strength and precision of any dose-to-dose contrast cannot be assessed from the posted results.
The primary outcome is pharmacokinetic, not a measure of clinical benefit. It reports blood concentration after dosing in healthy participants. It does not establish what concentrations mean for people with a disease, how the drug performs against an active treatment, or whether one dose is preferable in clinical practice. Those questions are outside what these posted endpoint summaries establish.
The enrollment and arm counts are modest in scale, and the endpoint population is defined as randomized participants who received at least one galcanezumab dose. The registry does not provide participant-level results or confidence intervals that would show how much the summaries might vary. The geometric coefficient of variation offers information about relative variability within each group, but it does not replace uncertainty estimates for a group mean or for a between-group effect.
The safety results are also descriptive. The registry lists serious adverse events, other adverse events, and deaths by group. The small group counts mean that event counts should be read as observations within this study, not as precise estimates of event frequency in a broader population. The record does not provide a formal comparative safety analysis.
Overall, the posted results characterize Cmax and adverse-event counts in this study. They do not establish a statistically tested difference between doses, nor do they support conclusions about efficacy or treatment choices. No sponsor analysis conflicts with the posted summaries in the registry record.
9. Statistical Methods Explained
The registry describes randomized allocation, double masking, and a parallel-group model. Randomization is generally used to reduce systematic differences between groups at entry, while masking is intended to limit the influence of treatment knowledge on participant behavior, care, or outcome assessment. These are general purposes of the design features; the methods used to generate allocation and preserve masking are not reported in the registry record.
What does the geometric mean summarize?
The primary outcome is reported as a geometric mean rather than an arithmetic mean. In general, a geometric mean summarizes positive measurements on a multiplicative scale. It is often useful for concentration data when values vary proportionally, rather than by a constant additive amount. The reported geometric means are 12.6 μg/mL for the 120 mg group and 27.2 μg/mL for the 240 mg group.
The accompanying geometric coefficient of variation is 23.0 in each active-dose group. In general, a coefficient of variation expresses variability relative to the scale of the measurements, rather than in the original measurement units. It helps describe dispersion, but it is not a confidence interval and does not show how precisely a difference between group means has been estimated. The registry does not provide confidence intervals or other uncertainty estimates for these Cmax values.
Why might concentration data need a different summary?
As a general statistical point, concentration measurements can be right-skewed: many observations may be relatively low, while a smaller number are substantially higher. If the distribution is skewed or variability increases with the mean, a geometric summary can be more representative than an arithmetic average. The registry’s choice of geometric mean is stated, but the rationale for choosing it and diagnostic checks of the concentration data are not reported in the registry record.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. If a model does not account for that extra variability, its standard errors and uncertainty estimates can be too small. The registry does not describe a model for the primary outcome or report an over-dispersion assessment. Thus, no specific modeling approach or diagnostic conclusion can be attributed to this study from the posted record.
What can be inferred from the posted summaries?
The geometric means and coefficients of variation are descriptive statistics. The registry lists 12 participants in each active-dose group, but does not provide participant-level concentrations, an estimate of the contrast between the groups, or an inferential test. A confidence interval, in general, describes a range of values compatible with a statistical estimate under the assumptions of a method. No confidence interval is posted for the group summaries or their comparison. A p-value is also not posted. Therefore, the fact that one listed geometric mean is numerically higher does not by itself establish that the groups differ beyond sampling variation.
The study summary lists post-dose measurement times from 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, and 3360 hours. The registry names the endpoint Cmax and gives this timeframe, but does not detail how measurements across these times were used to determine each participant’s maximum. The exact computational procedure is not reported in the registry record.
How should planning illustrations be read?
Any sample-size planning illustrations associated with these results use the observed effect as their starting point, with a stated fraction of that effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are planning illustrations, not observed power and not evidence that the study was designed using those assumptions. The registry record does not report the trial’s own sample-size justification. Planning estimates do not change the interpretation of the observed Cmax summaries and cannot substitute for a formal analysis.
The record lists no posted statistical analyses. It also does not describe an analysis model, covariate adjustment, multiplicity procedure, or sensitivity analysis. As a result, the statistical interpretation should remain close to the reported descriptive values and avoid treating them as a tested dose comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and no posted analyses. It lists no secondary outcomes with posted results. The available result is the primary pharmacokinetic endpoint, Cmax, summarized for the two galcanezumab dose groups. A formal strategy for controlling multiplicity across outcomes or statistical tests is not reported in the registry record. Since inferential tests are not posted, there is no stated adjustment to evaluate and no basis for claiming that multiplicity was or was not controlled in an analysis.
The primary outcome population is described as all randomized participants who received at least one dose of galcanezumab. The posted counts for the active-dose arms are 12 and 12. The registry does not state how many participants contributed measurements at each post-dose time, whether any measurements were missing, or how missing observations were handled. It also does not describe imputation, exclusion rules, or sensitivity analyses for missing pharmacokinetic data. Those details are not reported in the registry record.
The record does not say whether the primary endpoint analysis followed an intention-to-treat principle, used a per-protocol population, or applied another analysis-set definition beyond the stated endpoint population. It does not give a participant flow by analysis population. The absence of those details limits assessment of whether the reported summaries reflect all eligible participants or only those with particular data available.
These gaps matter because missing measurements and analysis-population choices can affect a pharmacokinetic summary. Without further details, the safest reading is to describe the posted group summaries and not infer the influence of missing data or unreported analyses.
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 | 0 | 6 | 0.0% |
| 120 mg Galcanezumab SC | 2 | 12 | 16.7% |
| 240 mg Galcanezumab SC | 1 | 12 | 8.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 6 |
| 120 mg Galcanezumab SC | 0 of 12 |
| 240 mg Galcanezumab SC | 0 of 12 |
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 | 5 of 6 |
| 120 mg Galcanezumab SC | 12 of 12 |
| 240 mg Galcanezumab SC | 12 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|---|
| Foot fracture | Injury, poisoning and procedural complications | 0 of 6 | 0 of 12 | 1 of 12 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 0 of 6 | 1 of 12 | 0 of 12 |
| Ureterolithiasis | Renal and urinary disorders | 0 of 6 | 1 of 12 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | 0 of 6 | 3 of 12 | 5 of 12 |
| Upper respiratory tract infection | Infections and infestations | 0 of 6 | 4 of 12 | 2 of 12 |
| Heart rate increased | Investigations | 1 of 6 | 2 of 12 | 1 of 12 |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 2 of 12 | 2 of 12 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1 of 6 | 3 of 12 | 0 of 12 |
| Injection site reaction | General disorders | 1 of 6 | 1 of 12 | 1 of 12 |
| Aspartate aminotransferase increased | Investigations | 0 of 6 | 1 of 12 | 2 of 12 |
| Blood pressure increased | Investigations | 0 of 6 | 0 of 12 | 3 of 12 |
| Urinary casts present | Investigations | 1 of 6 | 0 of 12 | 2 of 12 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 2 of 6 | 1 of 12 | 0 of 12 |
Serious events with the highest arm-level rate: foot fracture (8.3%), rhabdomyolysis (8.3%), ureterolithiasis (8.3%).
The registry lists serious adverse events for 0 of 6 participants in the placebo group, 2 of 12 in the 120 mg galcanezumab group, and 1 of 12 in the 240 mg group. It lists other adverse events for 5 of 6 participants receiving placebo and 12 of 12 participants in each galcanezumab group. No deaths are listed in any group.
These are counts from the participants at risk shown in the registry. They describe what was recorded during this study; they do not establish comparative risk or identify a causal relationship to study treatment. The group counts are small, and the registry does not post a formal statistical comparison, event timing, exposure-adjusted rates, or a detailed account of how events were attributed.
The serious-event terms listed are Foot fracture, Rhabdomyolysis, and Ureterolithiasis, each with a posted value of 8.3%. The record does not clearly specify the denominator associated with these term-level percentages, so they should not be interpreted as group-specific rates without further context. Serious-event counts and term listings are distinct summaries, and the term percentages should not be added or treated as a measure of overall risk.
12. What the Result Does, and Does Not, Mean
The results show that the registry recorded geometric mean maximum concentrations of 12.6 μg/mL after 120 mg galcanezumab and 27.2 μg/mL after 240 mg galcanezumab. The geometric coefficient of variation was 23.0 for both groups. These are descriptive pharmacokinetic summaries in healthy Chinese participants who received a single dose. The record also lists serious and other adverse-event counts for the placebo and active-dose groups.
The results do not show whether the difference between the two geometric means is statistically distinguishable from sampling variation. No confidence interval, p-value, or formal dose comparison is posted. The record does not provide a placebo value for Cmax, so it cannot support a posted primary-endpoint comparison with placebo. Nor do the concentration summaries establish clinical efficacy, a preferred dose, or what would happen in a population with a medical condition.
The safety counts likewise do not show that an event was caused by treatment or establish a reliable difference in risk between groups. The trial enrolled a limited number of participants, and the registry does not provide a formal safety comparison or detailed event-level context. The counts are informative as a record of events observed in the study, but they should not be generalized as precise rates.
In general, a phase 1 pharmacokinetic study can characterize concentration patterns and collect early safety information. Here, the registry’s posted primary result addresses maximum concentration; information about how long the body takes to remove galcanezumab is described as part of the study purpose, but an elimination result is not among the posted primary values. The conclusions should therefore remain bounded by the endpoint summaries and event counts actually listed.
13. Why This Trial Matters Statistically
This trial is statistically useful as an example of a randomized, double-masked, parallel-group pharmacokinetic study with two active dose groups and a placebo group. Its primary endpoint is a concentration summary rather than a clinical outcome. That distinction helps readers separate evidence about drug exposure from evidence about patient benefit, which is not assessed by the posted Cmax values.
The use of a geometric mean and geometric coefficient of variation also illustrates how pharmacokinetic results may be summarized on a multiplicative scale. Such summaries describe typical concentration and relative variability, but they do not replace confidence intervals or a formal comparison. The record reports both group summaries while providing no inferential analysis. This makes the boundary between descriptive evidence and tested conclusions especially important.
The trial also illustrates why counts and sample sizes need context. Group sizes are stated, and adverse-event counts are posted, but event counts in small groups do not alone estimate comparative risk precisely. Similarly, a numerical ordering of geometric means does not establish a dose effect without an estimate of uncertainty and a defined analysis.
Finally, the registry distinguishes the stated study purpose from the outcomes with posted results. The stated purpose includes assessing how long it takes the body to remove galcanezumab, while the primary posted endpoint is Cmax. That distinction shows why readers should identify the endpoint actually reported before drawing conclusions about broader pharmacokinetic aims.
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 endpoint summaries are limited to the two galcanezumab groups. No placebo Cmax value is posted, and the registry provides no estimate of a contrast between the active doses. Confidence intervals, p-values, and a formal statistical test are also absent. Without those, the precision of the reported group summaries and any dose comparison cannot be evaluated from the registry record.
The endpoint population is defined as randomized participants who received at least one galcanezumab dose. The record does not give the number contributing data at each time point, explain missing observations, or describe exclusions and analysis-set rules in detail. It also does not state how the participant-level maximum was derived from the listed post-dose times.
Methods that would help assess the results are not reported in the registry record, including the sample-size justification, statistical model, any covariate adjustment, multiplicity procedure, and sensitivity analyses. The record does not describe randomization implementation or how masking was maintained. These absences limit review of the assumptions and procedures behind the posted summaries.
The study involved healthy Chinese participants and single doses of galcanezumab or placebo. Its posted Cmax and safety findings should not be assumed to apply to other populations, dosing schedules, or clinical outcomes. Safety interpretation is further limited by small group counts and the lack of a formal comparative analysis. The listed serious-event term percentages have no clearly stated denominator context.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants — NCT04085289.
- Registry record last updated 2021-06-15; status last verified 2021-05.
- Results first posted 2021-06-15.
- 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
NCT04085289 is a completed phase 1 randomized, double-masked, parallel-group study of galcanezumab in healthy Chinese participants. Enrollment was 30. Participants received a single subcutaneous dose of placebo, 120 mg galcanezumab, or 240 mg galcanezumab. The primary endpoint was maximum galcanezumab concentration, summarized as a geometric mean and geometric coefficient of variation.
The posted Cmax geometric means are 12.6 μg/mL for 120 mg and 27.2 μg/mL for 240 mg; each group has a geometric coefficient of variation of 23.0. The registry lists serious adverse events in 0 of 6 placebo participants, 2 of 12 participants in the 120 mg group, and 1 of 12 in the 240 mg group. No deaths are listed. No inferential analysis, confidence interval, or p-value is posted, and a formal comparison between doses is not reported.