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 Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities (NCT04167553), a randomized phase 1 study. The primary outcome is To Evaluate the Incidence of AEs.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04167553 |
| Phase | Phase 1 |
| Condition | Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 52 |
| Arms in the primary outcome | 7 |
| Lead sponsor | Hanmi Pharmaceutical Company Limited |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes overweight or obese participants with comorbidities, including type 2 diabetes. Enrollment was 52. The posted primary outcome describes assessment from baseline to the end of treatment after multiple subcutaneous doses for 12 weeks.
Intervention
Participants were assigned to HM15136 at 0.02 mg/kg, 0.04 mg/kg, or 0.06 mg/kg in the listed study parts. The registry describes a planned cohort period of 22 weeks, including screening, treatment, and follow-up.
Comparator
The comparator was matching placebo. Placebo groups are listed for Part 1 and Part 2. The registry identifies the trial as randomized, double-masked, and parallel-group, but details of the allocation process and masking procedures are not reported in the registry record.
Primary question
The primary outcome concerns the incidence of adverse events classified as skin and subcutaneous tissue disorders. The posted results are participant counts in the listed dose and placebo groups. They do not include an estimated treatment contrast or an inferential test of HM15136 against placebo.
The central statistical question is therefore descriptive: how many participants in each listed group were reported with the specified category of adverse event? The registry also describes the broader study objectives as evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. Serum lipid profiles are listed as a secondary outcome. The available outcome counts do not answer every objective, and they should not be read as a complete account of all safety, pharmacokinetic, or pharmacodynamic findings.
3. Trial Design
This was a Phase 1 randomized, double-masked, parallel-group study of multiple doses of HM15136 and matching placebo. The registry reports enrollment of 52 and lists participants as overweight or obese with comorbidities, including type 2 diabetes. It records the study as completed. The recorded start date is 2019-08-30, and the primary completion date is 2020-12-09.
The listed HM15136 dose groups were 0.02 mg/kg, 0.04 mg/kg, and 0.06 mg/kg. The arm descriptions and posted outcomes distinguish Part 1 and Part 2, with placebo groups in both parts. Part 1 lists all three HM15136 dose levels, while Part 2 lists 0.02 mg/kg and 0.06 mg/kg. The registry record does not report the rationale for these parts or for which dose groups were included in each.
The planned period for each cohort is described as 22 weeks, including screening, 12 weeks of treatment, and follow-up. The primary outcome timeframe refers to multiple subcutaneous doses for 12 weeks and assessment from baseline to the end of treatment. The registry does not report the allocation sequence, the procedures used to maintain masking, or the exact timing and frequency of outcome assessments.
The stated study objectives include safety, tolerability, pharmacokinetics, and pharmacodynamics. The posted primary outcome is a count of participants with skin and subcutaneous tissue disorders. Serum lipid profiles are listed as a secondary outcome. The registry reports six outcome measures, but only one secondary outcome is identified in the record summarized for this analysis. Further details of the other measures 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: During cohort 0.06mg/kg in Part 2(cohort 5), enrolled subjects safety data were evaluated, and decided to stop the cohort. The following cohorts, cohort 6-7, were not conducted since those were optional.
Only the first 6 of 7 groups are shown.
Overall Study
| Stage | HM15136 0.02 mg/kg Part 1 | HM15136 0.04 mg/kg Part 1 | HM15136 0.06 mg/kg Part 1 | Placebo Part 1 | HM15136 0.02 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 |
|---|---|---|---|---|---|---|
| STARTED | 9 | 9 | 9 | 9 | 9 | 3 |
| COMPLETED | 8 | 9 | 6 | 7 | 6 | 1 |
| NOT COMPLETED | 1 | 0 | 3 | 2 | 3 | 2 |
Reasons for not completing this period:
| Reason | HM15136 0.02 mg/kg Part 1 | HM15136 0.04 mg/kg Part 1 | HM15136 0.06 mg/kg Part 1 | Placebo Part 1 | HM15136 0.02 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 1 | 2 | 1 | 0 |
| Physician Decision | 0 | 0 | 0 | 0 | 2 | 2 |
| Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: To evaluate Skin and subcutaneous tissue disorders occurance from baseline to end of treatment
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: During Part 2 0.06mg/kg(cohort 5), the safety profile of enrolled subjects were evaluated, and decided to stop enrolling subjects. Planned cohorts, cohort 6 to 7, were not conducted since those were optional.
Only the first 6 of 8 groups are shown.
| Characteristic | Unit | HM15136 0.02 mg/kg Part 1 | HM15136 0.04 mg/kg Part 1 | HM15136 0.06 mg/kg Part 1 | Placebo Part 1 | HM15136 0.02 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 |
|---|---|---|---|---|---|---|---|
| Participants analysed | 9 | 9 | 9 | 9 | 9 | 3 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 | 9 | 9 | 9 | 9 | 3 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 7 | 3 | 4 | 4 | 6 | 1 |
| Sex: Female, Male: Male | Participants | 2 | 6 | 5 | 5 | 3 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 2 | 2 | 1 | 1 | 0 |
| Race (NIH/OMB): White | Participants | 8 | 7 | 6 | 6 | 8 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 1 | 1 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 9 | 9 | 9 | 9 | 9 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as To Evaluate the Incidence of AEs, measured over after multiple subcutaneous (SC) doses for 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the incidence of adverse events classified as skin and subcutaneous tissue disorders. Its unit is participants, and the posted values are counts of participants with an event in each listed group. The timeframe is after multiple subcutaneous doses for 12 weeks, with the outcome description specifying assessment from baseline to the end of treatment.
Counting participants with at least one event in a defined category is a way to describe how often that type of event was reported within a group. The count is not a measure of how many separate episodes occurred, how long events lasted, or how severe they were. Those details are not reported for this endpoint in the registry record. Nor does the count alone establish whether events were judged related to study treatment.
In general, an adverse-event outcome is used in a safety-focused study to describe events arising during the observation period. Interpretation depends on the event definition, the period of observation, and the number of participants assessed. The registry gives a timeframe and group counts, but does not provide an adjusted comparison, confidence interval, or p-value for this outcome. Accordingly, the posted counts support a descriptive reading rather than a formal conclusion about differences between HM15136 and placebo.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome counts are 1 participant in HM15136 0.02 mg/kg Part 1, 2 in HM15136 0.04 mg/kg Part 1, 4 in HM15136 0.06 mg/kg Part 1, and 2 in Placebo Part 1. For Part 2, the counts are 2 in HM15136 0.02 mg/kg, 0 in HM15136 0.06 mg/kg, and 3 in Placebo. These are counts of participants with the specified skin and subcutaneous tissue disorder outcome, not counts of all adverse events.
The group sizes listed with these primary outcome counts vary. The posted values do not include percentages, uncertainty intervals, or tests comparing a dose group with placebo. No two-arm comparison was estimable in the posted analysis record, and no inferential analyses are reported. Consequently, the counts should not be treated as estimates of a treatment effect or as evidence that an apparent difference between groups is beyond chance variation.
In general, counts need their denominators and a clearly defined comparison to support a fair assessment of group differences. Even when group counts differ, interpretation requires attention to how many participants were assessed, the event definition, and the uncertainty around the comparison. A confidence interval, when reported, describes the precision of an estimate under the statistical model used; none is posted for this primary outcome. The registry also does not report an adjusted effect estimate or a prespecified statistical test for it.
There are distinctions between the primary outcome counts and the separate serious-adverse-event summary. The serious-event summary lists zero participants with serious events and zero deaths in each posted group. It also reports counts for other, non-serious adverse events. Those are different safety summaries and should not be substituted for the primary endpoint, which is specifically skin and subcutaneous tissue disorders.
The registry describes the trial as completed, but completion does not itself show that every planned outcome or analysis is available in the posted record. The stated study objectives include safety, tolerability, pharmacokinetics, and pharmacodynamics; the counts address only one specified safety outcome. Results for other objectives cannot be inferred from these counts. The appropriate reading is therefore limited: the record reports participant counts for this event category in the listed arms, without an inferential comparison or an accompanying measure of precision.
9. Statistical Methods Explained
The posted primary endpoint is binary at the participant level: a participant either appears in the count for the specified skin and subcutaneous tissue disorder outcome or does not. The reported result is a count, rather than a mean, median, or time-to-event estimate. This makes the outcome naturally interpretable as a number of participants with the event in each arm. The record does not provide an estimated risk difference, risk ratio, odds ratio, or other treatment contrast.
What does a count tell the reader?
A count communicates how many participants met the endpoint definition within a group. It does not, by itself, describe the proportion of the group affected unless a denominator and a calculated proportion are also given. Nor does a count describe event severity, duration, recurrence, or timing. The posted endpoint counts therefore answer a narrow descriptive question, not every question a reader might ask about adverse events.
In general, comparing binary outcomes requires a defined contrast between groups and a method for quantifying uncertainty. A confidence interval is a range of values compatible with the observed data under the assumptions of the method; it conveys precision as well as the direction and scale of an estimated contrast. A p-value, when used, measures how incompatible the data are with a specified null hypothesis under the test assumptions. Neither an interval nor a p-value is reported for this primary endpoint. The registry reports no analysis for a two-arm comparison of the binary endpoint.
Why are there no comparative estimates?
The posted record indicates that values were missing or not estimable for a two-arm comparison of this binary endpoint. It also reports no analyses. This means the displayed counts cannot be expanded into a sponsor-reported comparative result. It would be inappropriate to infer a formal finding from visually comparing the counts, or to treat the absence of an estimable comparison as evidence of equivalence. A small or sparse set of events can make estimates unstable, but the registry does not report a specific reason beyond the stated missing or non-estimable comparison.
In general, sparse binary outcomes can lead to wide uncertainty and may challenge methods that rely on large-sample approximations. Possible analytical choices include exact methods or models suited to sparse data, but the registry does not state which approach was planned or used. These are general statistical considerations, not a description of the trial's analysis. The record does not report its statistical analysis plan, a choice of test, or a rationale for the absence of an estimable comparison.
How should the planning illustrations be read?
Planning illustrations based on an observed effect are not the same as the trial's original sample-size justification. The registry's stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations are conditional on those assumptions and on the observed effect used as a reference. They are not observed power, and they do not establish that the study was designed to detect a particular effect. The trial's own sample-size justification is not reported in the registry record.
In general, a planning calculation describes the sample size that a hypothetical future study might require under specified assumptions. It does not change what the completed study observed, and it cannot supply missing uncertainty estimates or an unreported analysis. The posted record also specifies that time-to-event illustrations use total events, while other illustrations refer to participants per arm. Those conventions matter when interpreting a planning output, but no planning output should be confused with the observed participant counts.
What does the study structure imply?
Randomized, double-masked, parallel-group describe the broad design. Randomization can, in general, reduce systematic differences between groups at assignment, while masking can reduce certain measurement or behavior biases. These design labels do not establish how well procedures were implemented, and the registry does not report the sequence-generation or masking details. The multiple dose groups and separate study parts also mean that each group count should be read in its own listed context. The record does not report a pooled dose analysis or a prespecified dose-response model.
Overall, the statistical information available for the primary outcome is descriptive. There is no reported estimate of comparative effect, no uncertainty interval, and no reported inferential test. Statistical interpretation should remain within those limits, rather than treating the arm counts as a complete analysis.
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 |
|---|---|---|---|---|---|---|
| HM15136 0.02 mg/kg Part 1 | 9 | 1 | 11.1% | 0.3% to 48.2% | 2.0% to 43.5% | 2.5% to 44.5% |
| HM15136 0.04 mg/kg Part 1 | 9 | 2 | 22.2% | 2.8% to 60.0% | 6.3% to 54.7% | 6.7% to 55.6% |
| HM15136 0.06 mg/kg Part 1 | 9 | 4 | 44.4% | 13.7% to 78.8% | 18.9% to 73.3% | 18.7% to 73.8% |
| Placebo Part 1 | 9 | 2 | 22.2% | 2.8% to 60.0% | 6.3% to 54.7% | 6.7% to 55.6% |
| HM15136 0.02 mg/kg Part 2 | 6 | 2 | 33.3% | 4.3% to 77.7% | 9.7% to 70.0% | 9.9% to 71.0% |
| HM15136 0.06 mg/kg Part 2 | 2 | 0 | 0.0% | 0.0% to 84.2% | 0.0% to 65.8% | 0.8% to 70.8% |
R code and output
arm <- c("HM15136 0.02 mg/kg Part 1", "HM15136 0.04 mg/kg Part 1", "HM15136 0.06 mg/kg Part 1", "Placebo Part 1", "HM15136 0.02 mg/kg Part 2", "HM15136 0.06 mg/kg Part 2")
n <- c(9, 9, 9, 9, 6, 2)
events <- c(1, 2, 4, 2, 2, 0)
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 HM15136 0.02 mg/kg Part 1 9 1 11.1 0.3 48.2 2.0 43.5 2.5 44.5
ARM HM15136 0.04 mg/kg Part 1 9 2 22.2 2.8 60.0 6.3 54.7 6.7 55.6
ARM HM15136 0.06 mg/kg Part 1 9 4 44.4 13.7 78.8 18.9 73.3 18.7 73.8
ARM Placebo Part 1 9 2 22.2 2.8 60.0 6.3 54.7 6.7 55.6
ARM HM15136 0.02 mg/kg Part 2 6 2 33.3 4.3 77.7 9.7 70.0 9.9 71.0
ARM HM15136 0.06 mg/kg Part 2 2 0 0.0 0.0 84.2 0.0 65.8 0.8 70.811. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary safety outcome and serum lipid profiles as a secondary outcome. It also reports six outcome measures, while only one secondary outcome is identified in the summarized record. The relationship between those measures and the listed outcome is not reported in the registry record. The statistical analysis plan, including any approach to multiplicity, is not reported.
In general, multiplicity arises when several outcomes, dose comparisons, time points, or statistical tests are considered. Without a stated plan, readers cannot determine whether an adjustment was intended, which comparisons were considered primary, or how any false-positive risk was handled. No multiplicity-adjusted results are reported for the posted primary outcome.
The registry does not report missing-data methods, analysis populations, or details on participant-level completeness for the primary endpoint. The listed arm denominators and counts describe the posted results, but do not explain whether all randomized participants were included in each analysis or how any missing outcome assessments were handled. The record also does not state whether analyses followed an intention-to-treat, per-protocol, or safety population definition.
These omissions limit assessment of the analysis process. They do not establish that data were missing or that a particular analysis population was used. The safest interpretation is that those methods are not reported in the registry record.
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 |
|---|---|---|---|
| HM15136 0.02 mg/kg Part 1 | 0 | 9 | 0.0% |
| HM15136 0.04 mg/kg Part 1 | 0 | 9 | 0.0% |
| HM15136 0.06 mg/kg Part 1 | 0 | 9 | 0.0% |
| Placebo Part 1 | 0 | 9 | 0.0% |
| HM15136 0.02 mg/kg Part 2 | 0 | 9 | 0.0% |
| HM15136 0.06 mg/kg Part 2 | 0 | 3 | 0.0% |
| Placebo Part 2 | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HM15136 0.02 mg/kg Part 1 | 0 of 9 |
| HM15136 0.04 mg/kg Part 1 | 0 of 9 |
| HM15136 0.06 mg/kg Part 1 | 0 of 9 |
| Placebo Part 1 | 0 of 9 |
| HM15136 0.02 mg/kg Part 2 | 0 of 9 |
| HM15136 0.06 mg/kg Part 2 | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HM15136 0.02 mg/kg Part 1 | 1 of 9 |
| HM15136 0.04 mg/kg Part 1 | 2 of 9 |
| HM15136 0.06 mg/kg Part 1 | 4 of 9 |
| Placebo Part 1 | 2 of 9 |
| HM15136 0.02 mg/kg Part 2 | 2 of 9 |
| HM15136 0.06 mg/kg Part 2 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HM15136 0.02 mg/kg Part 1 | HM15136 0.04 mg/kg Part 1 | HM15136 0.06 mg/kg Part 1 | Placebo Part 1 | HM15136 0.02 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 |
|---|---|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | 1 of 9 | 2 of 9 | 4 of 9 | 2 of 9 | 2 of 9 | 0 of 3 |
The serious-adverse-event summary lists zero serious events among the participants at risk in each posted group, and zero deaths in every group. The listed at-risk counts vary by arm; these figures should be read alongside the corresponding group labels rather than combined into a single estimate. The record does not list serious adverse-event terms.
The same summary separately reports other adverse events: 1 in HM15136 0.02 mg/kg Part 1, 2 in HM15136 0.04 mg/kg Part 1, 4 in HM15136 0.06 mg/kg Part 1, and 2 in Placebo Part 1. In Part 2, the other-event counts are 2 in HM15136 0.02 mg/kg, 0 in HM15136 0.06 mg/kg, and 3 in Placebo. These are not serious-event counts and are not necessarily identical in definition to the primary endpoint.
In general, a reported zero means no event was recorded in that summary for the listed group; it does not prove that an event is impossible or establish comparative safety. With no comparative estimate or uncertainty interval, these data are descriptive. Some at-risk denominators in the serious-event summary differ from the group sizes listed for the primary endpoint. The registry record does not explain the denominator differences.
13. What the Result Does, and Does Not, Mean
The posted results establish that the registry reports participant counts for skin and subcutaneous tissue disorders in each listed HM15136 dose and placebo group. They also report no serious adverse events and no deaths in the listed groups in the separate serious-event summary. These are descriptive statements about the recorded outcomes, not a formal comparison of treatment groups.
The counts do not establish whether HM15136 changed the chance of this event relative to placebo. No comparative effect estimate, confidence interval, or p-value is posted for the primary endpoint. A difference between raw counts can reflect group size, random variation, or other factors; without a reported analysis, the record does not quantify the relative event frequency or its precision. The absence of a statistically reported comparison should not be interpreted as proof that groups were the same.
The endpoint is limited to skin and subcutaneous tissue disorders. It does not represent all adverse events, and its count does not show event severity, duration, or recurrence. The serious-event summary is distinct from this endpoint and likewise does not provide an inferential comparison.
The registry describes a Phase 1 study with broader safety, tolerability, pharmacokinetic, and pharmacodynamic objectives. The posted counts cannot answer all of those questions. Serum lipid profiles are listed as a secondary outcome, but no result for that measure is included in the registry record discussed in this interpretation. Outcomes not described in the registry record cannot be inferred from the primary safety counts.
In general, a completed study can still have results that are incomplete for a particular analytical question in the public record. Here, the evidence available supports a descriptive account of recorded participant counts, while the effect estimate, precision, and analysis methods needed for a stronger comparative interpretation are not reported in the registry record.
14. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical statistics: reporting outcome counts is not the same as reporting a treatment comparison. For a binary safety endpoint, counts show how many participants were recorded with an event in each group. A comparative estimate and its uncertainty are needed to assess how compatible the observed data are with a range of possible differences between groups. Neither is reported for this primary outcome.
The multiple dose levels and study parts make clear labeling especially important. The HM15136 dose groups and matching placebo groups are listed separately, and their posted participant counts differ. Keeping the groups distinct avoids implying a pooled or dose-response analysis that the registry does not report. It also highlights why raw counts cannot be compared without considering the relevant denominators and analysis methods.
The record also separates the primary endpoint from the serious-adverse-event summary. The primary outcome concerns a specified category of skin and subcutaneous tissue disorders, while the serious-event summary reports serious events, other events, and deaths. These measures answer different descriptive questions. Treating them as interchangeable would obscure what each result represents.
Finally, planning calculations based on observed effects are not a substitute for the trial's own design justification or for an analysis of the completed data. The registry's stated illustration assumptions can help frame hypothetical planning, but they do not provide observed power or demonstrate that the trial was adequately sized for a particular comparison. This case underscores the value of transparent endpoint definitions, denominators, analysis populations, and uncertainty estimates when reporting clinical trial results.
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 primary outcome is presented as participant counts without comparative estimates or measures of uncertainty. No inferential analysis is reported for the two-arm binary endpoint, and the record states that values were missing or not estimable for that comparison. This prevents estimation of the magnitude and precision of any difference between HM15136 and placebo from the posted primary results.
The registry does not report the statistical analysis plan, the sample-size justification, the planned handling of multiplicity, or missing-data methods. It also does not specify the analysis populations or provide details on the allocation sequence and masking procedures. These gaps make it difficult to assess how the analysis was intended to relate to the trial design.
Several listed group denominators in the primary outcome and serious-adverse-event summary differ. The registry record does not explain those differences, so the counts should be interpreted within their respective summaries rather than reconciled by assumption. Event severity, duration, recurrence, and attribution to study treatment are also not reported for the primary outcome.
The record identifies serum lipid profiles as a secondary outcome and reports six outcome measures, but the results and details for other measures are not available in the registry record. Therefore, the posted primary safety counts do not describe all study objectives or all possible outcomes. The trial's Phase 1 setting and group-specific counts further counsel against extrapolating beyond the recorded descriptive findings.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities — NCT04167553.
- Registry record last updated 2025-01-27; status last verified 2025-01.
- Results first posted 2025-01-27.
- 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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19. Record Summary
NCT04167553 is a completed randomized, double-masked, parallel-group Phase 1 study of multiple HM15136 doses and matching placebo in overweight or obese participants with comorbidities, including type 2 diabetes. Enrollment was 52. The planned period for each cohort was 22 weeks, including screening, 12 weeks of treatment, and follow-up.
The primary outcome counts participants with skin and subcutaneous tissue disorders from baseline to the end of treatment. Counts are posted by dose group and study part, but no two-arm comparison, effect estimate, confidence interval, or p-value is reported. The separate serious-event summary lists zero serious events and zero deaths in the posted groups. Serum lipid profiles are listed as a secondary outcome.
The registry record does not report the statistical analysis plan, sample-size justification, multiplicity approach, missing-data methods, or analysis populations. The findings available for the primary outcome are descriptive and do not establish a comparative treatment effect.