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 Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis (NCT02357420), a randomized phase 2 study. The primary outcome is Change From Baseline to Week 12 in Weekly Vomiting Episodes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02357420 |
| Phase | Phase 2 |
| Condition | Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 393 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Participants had Type 1 or Type 2 diabetes mellitus and moderate to severe diabetic gastroparesis with vomiting symptoms. The Full Analysis Set included randomized participants who received at least 1 dose of study treatment and had at least 1 postbaseline primary efficacy measurement. The number analyzed at a time point was the number with data available then.
Intervention
Relamorelin was given by subcutaneous injection twice daily for 12 weeks. The three active regimens were 10 μg, 30 μg, and 100 μg.
Comparator
The comparator was placebo-matching relamorelin, given by subcutaneous injection twice daily for 12 weeks.
Primary question
The primary endpoint was change from baseline to Week 12 in weekly vomiting episodes, measured with the Diabetic Gastroparesis Symptoms Severity Diary. The registry record does not report a single primary comparison result across the treatment groups.
3. Trial Design
This was a Phase 2b, randomized, quadruple-masked, parallel-group, placebo-controlled study. The registry record lists an enrollment of 393 and a completed status. The recorded study start was 2015-01-29, and the primary completion date was 2016-06-09. Allergan is listed as the sponsor.
Participants were assigned to one of four regimens: relamorelin 10 μg, relamorelin 30 μg, relamorelin 100 μg, or placebo. Each regimen was administered by subcutaneous injection twice daily for 12 weeks. The registry describes the study as evaluating multiple dose regimens in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Participants had vomiting symptoms and moderate to severe diabetic gastroparesis.
Random allocation is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. A parallel-group design assigns each participant to a regimen rather than comparing successive regimens within the same participant. Placebo provides a comparator under the study conditions, while masking is intended to reduce the influence of treatment knowledge on participants’ reports and study conduct. The record identifies quadruple masking but does not specify which groups of people were masked.
The planned study period for each regimen was 12 weeks. The registry lists a primary endpoint and two secondary outcomes: change in a weekly four-symptom composite score and change in gastric emptying measured by the gastric emptying breath test half-time. The statistical analysis plan, including the planned treatment contrasts and any adjustment for multiple comparisons, is 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: A total 393 participants were randomized and received study treatment, and 334 participants completed the study. Five participants who received study drug but discontinued prematurely were summarized as completing the study because they fulfilled the Visit 8 (Week 12) assessments as per protocol.
Overall Study
| Stage | Placebo | Relamorelin 10 μg | Relamorelin 30 μg | Relamorelin 100 μg |
|---|---|---|---|---|
| STARTED | 104 | 98 | 109 | 82 |
| Full Analysis Set (FAS) | 104 | 98 | 109 | 81 |
| COMPLETED | 92 | 86 | 93 | 63 |
| NOT COMPLETED | 12 | 12 | 16 | 19 |
Reasons for not completing this period:
| Reason | Placebo | Relamorelin 10 μg | Relamorelin 30 μg | Relamorelin 100 μg |
|---|---|---|---|---|
| Adverse Event | 3 | 3 | 8 | 9 |
| Investigator Decision | 1 | 0 | 0 | 0 |
| Prohibited Medication | 1 | 1 | 0 | 0 |
| Protocol Non-compliance | 0 | 0 | 0 | 1 |
| Withdrawn Consent | 4 | 8 | 6 | 6 |
| Lost to Follow-up | 3 | 0 | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.
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: Safety Set (SS) included all participants who were randomized and received at least 1 dose of study treatment.
| Characteristic | Unit | Placebo | Relamorelin 10 μg | Relamorelin 30 μg | Relamorelin 100 μg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 104 | 98 | 109 | 82 | 393 | |
| Age, Continuous | years | 55.7 (SD 11.9) | 59.3 (SD 10.2) | 56.0 (SD 11.7) | 57.1 (SD 11.0) | 57.0 (SD 11.3) |
| Sex: Female, Male: Female | Participants | 64 | 59 | 65 | 57 | 245 |
| Sex: Female, Male: Male | Participants | 40 | 39 | 44 | 25 | 148 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline to Week 12 in Weekly Vomiting Episodes, measured over 7 days prior to Day 1 for Baseline to 7 days prior to Week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | vomiting episodes per week |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint was change from baseline to Week 12 in weekly vomiting episodes, expressed as vomiting episodes per week. Episodes were recorded in the Diabetic Gastroparesis Symptoms Severity Diary, a participant-reported daily diary covering core signs and symptoms of diabetic gastroparesis as well as the frequency of vomiting. Each day, participants recorded the number of episodes in the prior 24 hours. The weekly score was averaged across the 12 weeks period.
Change compares a participant’s Week 12 measure with baseline. The registry defines baseline as the 7 days prior to Day 1 and the Week 12 measure as the 7 days prior to Week 12. A negative change indicates fewer vomiting episodes relative to baseline and is described in the record as improvement. This direction is important when interpreting a mean change: negative values and positive values have different meanings under the endpoint definition.
A weekly measure is used to represent vomiting frequency over a period rather than relying on a single day’s report. Participant diaries can capture symptoms that may not be evident in a clinic assessment, though reported frequency remains dependent on diary completion and reporting. The registry record describes how the endpoint was assessed but does not report a single treatment comparison or its precision. The clinical importance of any particular change is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a direct, participant-reported primary endpoint: change in weekly vomiting episodes from baseline to Week 12. It also specifies the direction of interpretation: a negative change indicates improvement relative to baseline. However, the primary outcome has several categories or time points and is not reduced to one comparison in the record. A single treatment effect, confidence interval, or p-value for the primary comparison is therefore not reported in the registry record.
This absence matters for interpretation. The study has three relamorelin dose groups and a placebo group, but the registry record does not present a single primary contrast that can be used to summarize the randomized comparison. Without a posted primary comparison estimate and its uncertainty, readers cannot assess the size or precision of a treatment-group difference from this record. The endpoint description alone is not evidence that a group difference was observed.
The Full Analysis Set was defined as randomized participants who received at least 1 dose and provided at least 1 postbaseline primary efficacy measurement. The number analyzed at a given time point was the number with data available at that time point. Thus, the analyzed count can reflect availability of measurements, not only the total enrollment. The record does not report how many participants contributed to each primary endpoint time point or how missing measurements were handled in the efficacy analysis.
There are also two secondary outcomes: change in a weekly composite of nausea, bloating, early satiety, and abdominal pain, and change in gastric emptying breath test half-time. These measure related but distinct aspects of symptoms and gastric emptying. Their presence does not establish that they were analyzed using a particular model or that their results support or contradict the primary endpoint. Their comparison estimates and uncertainty are not reported in the registry record.
The safety counts provide descriptive information by assigned group. Serious adverse events affected 8 participants in the placebo group, 7 in the 10 μg group, 10 in the 30 μg group, and 6 in the 100 μg group. The registry also reports other adverse events and one death in the 100 μg group. These counts are not, on their own, evidence of a causal relationship to study treatment or a complete assessment of comparative safety. Attribution, event timing, and statistical comparisons are not reported in the registry record.
Overall, the record supports a description of the design, endpoint, analysis population definition, and listed safety counts. It does not provide enough primary efficacy results to characterize the magnitude or precision of the randomized treatment comparisons. No conclusion about treatment benefit should be drawn from the endpoint definition or from the absence of a reported comparison.
9. Statistical Methods Explained
What does a change score represent?
A change score expresses how an outcome differs from a participant’s baseline value at a later assessment. For this trial, the outcome was weekly vomiting episodes, and a negative change was defined as improvement. The registry identifies the baseline and Week 12 assessment windows, but does not report a single comparison of changes between a relamorelin group and placebo.
When a study reports mean change, the mean describes the average change among the participants included in that analysis. It does not show that every participant changed by the same amount. The standard deviation describes the spread of participant values around the mean; it is not the uncertainty in the estimated mean and is not a confidence interval. The registry identifies the primary outcome as a mean with standard deviation, but the corresponding primary comparison estimates are not reported in the registry record.
Why does the comparison matter?
Change from baseline within a group describes how that group’s outcome changed over time. A randomized comparison between groups addresses a different question: whether outcomes differed between assigned regimens under the trial conditions. A within-group change alone cannot separate an intervention-associated difference from changes that might also occur in the placebo group. The registry record does not reduce the primary outcome to one comparison, so it does not provide a single estimate that answers this comparative question.
A confidence interval, when reported, describes a range of values compatible with the data and the statistical method used. Its width conveys precision: a narrower interval indicates greater precision than a wider interval. It does not by itself establish clinical importance, and it does not mean that all values in the interval are equally likely. No confidence interval for a single primary comparison is reported in the registry record.
What does randomization contribute?
Randomization assigns participants to study groups by chance. In expectation, this helps balance characteristics that could influence outcomes, including characteristics that were not measured. It does not guarantee identical groups in a particular trial, and it does not address every source of bias after assignment. Masking can reduce the influence of treatment knowledge on symptom reporting, assessment, or other study processes. The registry identifies randomization and quadruple masking; details about who was masked are not reported in the registry record.
The parallel design means the study compares distinct groups assigned to the four regimens. The placebo group provides a concurrent reference under the study’s conditions. The design description does not specify the statistical model used to compare groups, whether baseline values were included as covariates, or how repeated measurements were handled. Those analysis details are not reported in the registry record.
How should the analysis population be read?
The Full Analysis Set included randomized participants who received at least 1 dose and provided at least 1 postbaseline primary efficacy measurement. This definition excludes randomized participants who did not meet those conditions. The number analyzed at each time point is the number with data available at that time point, according to the registry description. A count for a particular endpoint assessment therefore need not equal the enrollment count.
Missing data can affect estimates when the participants with observed measurements differ systematically from those without them. Statistical methods for missing measurements make assumptions about the relationship between observed and unobserved data. The registry record does not report the missing-data method or the assumptions used for the primary analysis. It is therefore not possible to assess from this record how sensitive the efficacy findings are to missing measurements.
What is multiplicity?
Multiplicity arises when a study makes several statistical comparisons or evaluates multiple outcomes. If each comparison is tested separately without an adjustment, the chance of at least one false-positive finding across the set can increase. Studies may address multiplicity through a prespecified hierarchy, adjustment procedure, or another strategy. The registry lists several dose groups and outcomes, but its statistical plan and any multiplicity strategy are not reported in the registry record. The listed outcomes alone do not establish which tests were confirmatory.
How do planning illustrations differ from trial results?
Planning illustrations based on an observed effect are not the trial’s design justification and are not observed power. The registry record does not report a sample-size justification or the assumptions used when planning the study. A planning illustration using the stated assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation is a hypothetical calculation about a future design. It does not replace the observed comparison, its uncertainty, or a prespecified analysis plan. The registry record does not report the trial’s own justification for enrollment.
In general, over-dispersion means that observed variability is greater than a model assumes. When that occurs, standard errors based on the narrower variability assumption can be too small, making intervals too narrow and tests too optimistic. This is a general statistical consideration, not a reported feature of this trial. The registry record does not identify an over-dispersion assessment or model for the vomiting episode outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple relevant outcomes: weekly vomiting episodes as the primary outcome, a weekly composite of nausea, bloating, early satiety, and abdominal pain, and gastric emptying breath test half-time. There are also three relamorelin dose groups and a placebo group. A study with several outcomes and possible treatment comparisons needs a clear analysis strategy to show which comparisons are primary and how the interpretation accounts for multiple testing. The multiplicity plan is not reported in the registry record.
The primary outcome is not reduced to a single comparison in the registry record. As a result, it is not possible to identify a reported primary contrast, its estimate, or its precision. The statistical model, covariate adjustment, and handling of repeated assessments are also not reported in the registry record. The registry’s outcome descriptions do not establish whether a particular comparison was prespecified or treated as confirmatory.
The Full Analysis Set included randomized participants who received at least 1 dose and provided at least 1 postbaseline primary efficacy measurement. The number analyzed at each time point was the number with data available at that time point. This definition and count rule describe who contributed data, but do not explain how missing outcome measurements were handled. The missing-data method, reasons for missingness, and any sensitivity analyses are not reported in the registry record.
These omissions limit assessment of whether the analysis population, multiplicity approach, and missing-data assumptions support a reliable interpretation of treatment comparisons. They do not establish that a particular analysis was inappropriate; they mean that these aspects cannot be evaluated from the registry record.
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 | 8 | 104 | 7.7% |
| Relamorelin 10 μg | 7 | 98 | 7.1% |
| Relamorelin 30 μg | 10 | 109 | 9.2% |
| Relamorelin 100 μg | 6 | 82 | 7.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 104 |
| Relamorelin 10 μg | 0 of 98 |
| Relamorelin 30 μg | 0 of 109 |
| Relamorelin 100 μg | 1 of 82 |
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 | 13 of 104 |
| Relamorelin 10 μg | 21 of 98 |
| Relamorelin 30 μg | 30 of 109 |
| Relamorelin 100 μg | 28 of 82 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Relamorelin 10 μg | Relamorelin 30 μg | Relamorelin 100 μg |
|---|---|---|---|---|---|
| Impaired gastric emptying | Gastrointestinal disorders | 2 of 104 | 1 of 98 | 0 of 109 | 1 of 82 |
| Angina unstable | Cardiac disorders | 0 of 104 | 0 of 98 | 2 of 109 | 0 of 82 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 1 of 104 | 0 of 98 | 1 of 109 | 0 of 82 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 0 of 104 | 1 of 98 | 1 of 109 | 0 of 82 |
| Renal failure acute | Renal and urinary disorders | 0 of 104 | 0 of 98 | 1 of 109 | 1 of 82 |
| Angina pectoris | Cardiac disorders | 1 of 104 | 0 of 98 | 0 of 109 | 0 of 82 |
| Arteriosclerosis coronary artery | Cardiac disorders | 0 of 104 | 1 of 98 | 0 of 109 | 0 of 82 |
| Biliary tract disorder | Hepatobiliary disorders | 1 of 104 | 0 of 98 | 0 of 109 | 0 of 82 |
| Cardiac failure congestive | Cardiac disorders | 0 of 104 | 0 of 98 | 0 of 109 | 1 of 82 |
| Cardio-respiratory arrest | Cardiac disorders | 0 of 104 | 0 of 98 | 1 of 109 | 0 of 82 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Relamorelin 10 μg | Relamorelin 30 μg | Relamorelin 100 μg |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | 7 of 104 | 7 of 98 | 8 of 109 | 6 of 82 |
| Hyperglycaemia | Metabolism and nutrition disorders | 2 of 104 | 5 of 98 | 10 of 109 | 10 of 82 |
| Diarrhoea | Gastrointestinal disorders | 0 of 104 | 4 of 98 | 7 of 109 | 6 of 82 |
| Headache | Nervous system disorders | 3 of 104 | 4 of 98 | 6 of 109 | 2 of 82 |
| Blood glucose increased | Investigations | 1 of 104 | 3 of 98 | 4 of 109 | 6 of 82 |
| Dizziness | Nervous system disorders | 1 of 104 | 0 of 98 | 1 of 109 | 5 of 82 |
Serious events with the highest arm-level rate: impaired gastric emptying (1.9%), angina unstable (1.8%), renal failure acute (1.2%), cardiac failure congestive (1.2%), diabetes mellitus inadequate control (1.2%).
The registry lists the number of participants at risk and the number affected by serious and other adverse events in each group. Serious adverse events affected 8 of 104 participants in the placebo group, 7 of 98 in the relamorelin 10 μg group, 10 of 109 in the relamorelin 30 μg group, and 6 of 82 in the relamorelin 100 μg group. Other adverse events affected 13, 21, 30, and 28 participants in those respective groups. These are descriptive counts; they do not by themselves show whether group differences are statistically meaningful or caused by treatment.
The registry reports no deaths in the placebo, 10 μg, or 30 μg groups, and 1 death in the 100 μg group. The record does not report whether the death was considered related to study treatment. The listed serious-event terms include impaired gastric emptying, unstable angina, acute renal failure, congestive cardiac failure, inadequate control of diabetes mellitus, and Escherichia urinary tract infection. The registry provides percentages alongside these terms, but the event-level details and attribution are not reported in the registry record.
Counts of participants affected do not indicate the number of event episodes, their timing, duration, severity beyond the serious classification, or relationship to treatment. Comparisons also require consideration of group sizes and study exposure. The registry record does not provide a statistical comparison of these safety counts. The figures should therefore be read as descriptive safety reporting rather than as a stand-alone causal assessment.
12. What the Result Does, and Does Not, Mean
The trial’s design addresses a clinically relevant statistical question: whether different relamorelin regimens produce different changes in weekly vomiting episodes compared with placebo among participants with vomiting symptoms and moderate to severe diabetic gastroparesis. Randomization, a concurrent placebo group, and masking are features that can support a fair comparison when implemented and analyzed appropriately. The registry record identifies these design features but does not provide a single primary treatment comparison.
That distinction separates the intended question from the evidence available in the registry record. The record explains how vomiting episodes were measured and how a negative change should be interpreted, but it does not report a primary estimate, confidence interval, or p-value for a single comparison. The magnitude of any difference, its precision, and whether the results are compatible with a range of possible effects are therefore not reported in the registry record. The endpoint description cannot substitute for those results.
The record also lists two secondary outcomes and adverse event counts. These add context about what the study evaluated and what safety information was posted, but they do not resolve the missing primary comparison. Nor do descriptive safety counts establish that events were caused by treatment. The registry record does not report event attribution or a comparative statistical safety analysis.
Even when a treatment comparison is available, statistical evidence and clinical importance are distinct. An estimate can be statistically distinguishable from no difference yet have limited practical importance, or it can be imprecise enough that the data remain compatible with materially different effects. Judging those questions requires the estimated effect, uncertainty, and a clinical context for interpreting the change. Those primary efficacy details are not reported in the registry record.
Accordingly, the record can be used to describe the trial’s population, treatment regimens, endpoint definition, analysis-population rule, and posted safety counts. It cannot establish from the information recorded whether relamorelin improved vomiting symptoms, whether one dose differed from another, or how precise any such comparison was. No treatment recommendation follows from these registry entries.
13. Why This Trial Matters Statistically
This trial illustrates why a registry entry needs more than a named endpoint to support statistical interpretation. The endpoint is clearly defined as change in weekly vomiting episodes, with diary-based assessment and an explicit direction for improvement. Yet the record does not reduce the primary outcome to a single comparison. Without a reported contrast and its uncertainty, the central randomized question cannot be answered from the registry entry.
The study also has several active regimens and secondary outcomes. That structure raises questions about which comparisons were planned as primary, how evidence across dose groups should be interpreted, and whether any multiplicity strategy was used. Those details are not reported in the registry record. A list of outcomes and treatment groups does not reveal the hierarchy of statistical claims.
The Full Analysis Set definition and time-point-specific count rule are useful for understanding who could contribute efficacy data. However, without the actual numbers analyzed at each time point and the missing-data approach, readers cannot evaluate how complete the outcome data were or how missing observations may have influenced estimates. This is especially relevant to a participant-reported endpoint collected over time.
Finally, the safety counts demonstrate the difference between descriptive reporting and causal inference. Numbers of participants affected can help readers understand what the registry recorded, but interpretation also depends on event detail, exposure, attribution, and comparative methods. The record does not report enough information to resolve those questions. Taken together, the trial is statistically informative as an example of a defined randomized design whose registry record leaves key efficacy and analysis details unavailable.
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 principal limitation for interpreting efficacy is that the registry record does not present a single primary comparison, despite describing the endpoint and analysis population. Primary estimates, confidence intervals, and p-values for such a comparison are not reported in the registry record. The posted primary outcome has several categories or time points and is not reduced to one comparison.
The record describes the Full Analysis Set and says that the number analyzed is the number with data available at a given time point. It does not report the time-point-specific analysis counts or the method used to address missing measurements. The potential influence of missing outcome data therefore cannot be assessed from the registry record.
The statistical analysis plan is not reported in the registry record. In particular, the record does not specify the planned treatment contrasts, model, covariate adjustment, handling of repeated measurements, multiplicity procedure, or whether sensitivity analyses were performed. The study’s sample-size justification is also not reported in the registry record.
Safety reporting is limited to affected-participant counts, deaths, and listed serious-event terms with percentages. The registry record does not report event attribution, timing, detailed event descriptions, or a comparative statistical safety analysis. The listed counts should not be interpreted as proof that a treatment caused or prevented an event.
These limitations concern what can be evaluated from the registry record. They do not establish that the full study lacked additional analyses or reporting; those details are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis — NCT02357420.
- Registry record last updated 2019-07-24; status last verified 2019-06.
- Results first posted 2019-07-24.
- 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
NCT02357420 is a completed Phase 2b randomized, quadruple-masked, parallel, placebo-controlled study sponsored by Allergan. The registry lists an enrollment of 393. The study evaluated relamorelin 10 μg, 30 μg, and 100 μg, each given by subcutaneous injection twice daily for 12 weeks, against placebo.
The primary outcome was change from baseline to Week 12 in weekly vomiting episodes assessed with the Diabetic Gastroparesis Symptoms Severity Diary. A negative change indicates improvement. Secondary outcomes concerned a weekly gastroparesis symptom composite and gastric emptying breath test half-time. The Full Analysis Set required randomization, at least 1 dose, and at least 1 postbaseline primary efficacy measurement.
The registry reports group-level adverse event counts and one death in the 100 μg group. It does not report a single primary efficacy comparison, the statistical analysis plan, the missing-data method, or the multiplicity approach. The listed endpoint and safety details therefore support description of the trial, but not a complete assessment of comparative efficacy or safety.