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 Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) (NCT06643377), a non-randomized phase 1 study. The primary outcome is Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06643377 |
| Phase | Phase 1 |
| Condition | Healthy, Renal Impairment |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with severe renal impairment and healthy participants. The registry record lists an enrollment of 27 and describes two parallel panels. It does not report further demographic or clinical characteristics for either group.
Intervention
Participants in both panels received enlicitide once daily for 28 days. The study was open-label, so masking was not used.
Comparator
The comparison was between the severe renal impairment panel and the healthy panel. Allocation was non-randomized, so the groups should not be treated as randomized, like-for-like controls.
Primary question
The study asked how enlicitide exposure over the 24 hours after a dose, measured by plasma AUC0-24, compares between participants with severe renal impairment and healthy participants. The registry record states the researchers’ expectation that total exposure would be similar, but does not report the endpoint estimates needed to assess that expectation.
This is a pharmacokinetic question: it concerns the concentration of enlicitide in plasma over time after dosing, rather than a clinical outcome such as a change in cholesterol or a health event. The primary measure is specified for Day 28, after repeated daily dosing. Measurements were scheduled before the dose and at 1, 3, 8, and 24 hours after the dose.
The registry describes the study as Phase 1 and identifies its purpose as evaluating what happens to enlicitide in the body in the two participant groups. It does not report the actual AUC0-24 values, the estimated difference or ratio between groups, or a confidence interval for the comparison. Consequently, the registry record alone does not show how close the observed exposure estimates were, or how precisely the groups could be compared.
3. Trial Design
This completed Phase 1 study evaluated enlicitide pharmacokinetics in participants with severe renal impairment and healthy participants. The official title describes an open-label, multiple-dose study. The registry lists a parallel model, non-randomized allocation, and no masking. These features mean that participants were assigned to panels according to the study’s group structure rather than through random allocation, and that treatment identity was not concealed.
Panel A consisted of participants with severe renal impairment, who received enlicitide once daily for 28 days. Panel B consisted of healthy participants, who also received enlicitide once daily for 28 days. The primary endpoint was AUC0-24 of enlicitide in plasma on Day 28, with blood sampling scheduled predose and at 1, 3, 8, and 24 hours postdose. The registry lists an enrollment of 27.
The study began on 2024-11-22, reached primary completion on 2025-06-25, and is listed as completed. The sponsor is Merck Sharp & Dohme LLC. The registry identifies seven outcome measures and two analyses, but does not report their full results in the record.
Because allocation was non-randomized, the group comparison is not equivalent to a randomized treatment comparison. The two panels differ by renal status, and the registry record does not give enough information to assess how participant characteristics, selection, or other design features may have affected comparability. The study’s stated aim is pharmacokinetic comparison, not estimation of a treatment effect on a clinical outcome. The registry record does not report the detailed protocol, the rationale for the enrollment target, or additional design procedures.
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 | Panel A: Severe Renal Impairment Participants | Panel B: Healthy Participants |
|---|---|---|
| STARTED | 15 | 12 |
| COMPLETED | 15 | 12 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All treated participants who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
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.
| Characteristic | Unit | Panel A: Severe Renal Impairment Participants | Panel B: Healthy Participants | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 12 | 27 | |
| Age, Continuous | Years | 70.6 (SD 10.9) | 67.0 (SD 3.8) | 69.0 (SD 8.6) |
| Sex: Female, Male: Female | Participants | 7 | 5 | 12 |
| Sex: Female, Male: Male | Participants | 8 | 7 | 15 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 10 | 14 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 | 1 | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 | 1 | 5 |
| Race (NIH/OMB): White | Participants | 11 | 10 | 21 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide, measured over Day 28 predose and 1, 3, 8, and 24 hours postdose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | hr*nmol/L |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the plasma concentration-versus-time curve from time zero to 24 hours, abbreviated AUC0-24, for enlicitide. It is reported in hr*nmol/L. In general, an area-under-the-curve measure combines concentration measurements across a specified period. It therefore represents overall plasma exposure during that interval, rather than a single concentration at one sampling time.
The endpoint is specified for Day 28, after participants had received once-daily dosing for 28 days. The scheduled measurements were predose and 1, 3, 8, and 24 hours postdose. AUC0-24 is relevant to the study question because the registry’s stated aim is to compare enlicitide exposure over a 24-hour period between participants with severe renal impairment and healthy participants.
The registry describes the primary measure as a geometric mean with a 95% confidence interval. In general, geometric means summarize positive measurements on a multiplicative scale, and a confidence interval expresses uncertainty around an estimate under the analysis assumptions. The registry record does not report the geometric means, confidence intervals, or a numerical comparison between the panels. It also does not provide enough information to assess how the reported endpoint was derived from the scheduled samples.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical question is whether enlicitide exposure over the specified 24-hour interval differs between the severe renal impairment panel and the healthy panel. The registry’s brief summary states that researchers expected total exposure to be similar. That expectation is a statement of the study’s premise; it is not an observed finding.
The registry record does not report the primary AUC0-24 estimates, their 95% confidence intervals, or a direct comparison between groups. It therefore does not establish whether the observed values were similar, whether any difference was small or large, or how precisely the comparison was estimated. Without those results, the primary statistical question cannot be answered from the registry record.
A confidence interval is generally useful because it indicates the range of values compatible with the data and analysis assumptions. If the interval is wide, the estimate is less precise; if it is narrow, the estimate is more precise. For a comparison intended to assess similarity, the interval’s position and width need to be considered in relation to a prespecified definition of similarity. The registry record does not report such a definition, a threshold for an acceptable difference, or the interval for the primary endpoint. No conclusion about similarity should be inferred from the stated expectation alone.
The comparison also requires care because the study was non-randomized. Random allocation is one way to make groups comparable on average, but it was not used. The groups represent different renal-status panels, and the registry record does not report enough detail to judge the extent to which other participant characteristics were balanced or addressed analytically. Thus, even if numerical group estimates were available, interpretation would need to account for the design and the population represented.
The registry lists seven outcome measures and two analyses, but does not describe the complete statistical plan or identify how the analyses relate to the outcomes. The primary endpoint is identified, but the record does not report a statistical test, a model for the comparison, or a multiplicity strategy. These omissions limit assessment of how the primary result was intended to be evaluated and how secondary results should be interpreted.
Safety information is reported separately from the pharmacokinetic endpoint. The record lists serious adverse event counts for each panel and lists serious event terms with percentages. These figures describe recorded events in the study groups; they do not supply the missing AUC0-24 results and should not be used to infer pharmacokinetic exposure. The safety counts are also descriptive in this non-randomized study and do not establish a causal comparison between renal-status groups.
Any sample-size illustrations associated with observed effects are planning exercises, not observed power. The registry record does not report a sample-size justification for the original study or a numerical endpoint effect to evaluate. Such planning illustrations cannot substitute for the actual estimates, confidence intervals, and analysis details needed to interpret the primary comparison.
9. Statistical Methods Explained
The record identifies the primary endpoint and its summary form, but it does not report the detailed statistical analysis plan or the numerical endpoint results. The explanations below describe general statistical concepts relevant to reading this kind of pharmacokinetic study; they do not assert that a particular unreported procedure was used.
What does AUC0-24 represent?
In general, an area under a concentration-time curve combines concentration information across a defined time interval. For this study, the specified interval runs from time zero through 24 hours after dosing, and the outcome is plasma enlicitide exposure. AUC differs from a single concentration measurement: concentrations can vary over time, and the area reflects the overall profile across the interval. How the area is estimated depends on the data and analysis procedure. The registry record lists sampling before the Day 28 dose and at 1, 3, 8, and 24 hours after dosing, but does not describe the calculation method.
Why report a geometric mean?
In general, a geometric mean is useful for positive measurements that are naturally interpreted on a multiplicative scale. It is calculated by transforming observations, averaging on the transformed scale, and transforming back. This can make a summary more appropriate when values are skewed or when proportional rather than additive differences are of interest. The registry identifies the primary summary as a geometric mean, but does not report the individual observations, the distribution of the endpoint, or the exact analysis used to produce the summary.
How should a confidence interval be read?
In general, a confidence interval expresses statistical uncertainty around an estimate under a specified method and its assumptions. It is not a guarantee that the true value lies within the interval, nor does it describe the range of individual participant measurements. A point estimate alone can conceal substantial uncertainty; the interval helps readers assess precision. For the primary endpoint, the record specifies a 95% confidence interval, but does not report its bounds. It is therefore not possible to assess precision from the registry record.
What does the group comparison require?
The research question compares exposure in the severe renal impairment panel with exposure in the healthy panel. In general, a comparison may be expressed as a difference or a ratio, and the choice should align with the endpoint scale and the scientific question. The registry record does not report the form of the comparison, its estimate, or its uncertainty. It also does not describe a formal criterion for deciding what degree of difference would count as similar exposure. A stated expectation of similarity is not itself a statistical test or an equivalence margin.
Non-randomized allocation is important to interpretation. In general, randomization can reduce systematic differences between groups, while non-randomized groups may differ in characteristics beyond the factor defining the groups. Here, the panels are defined by renal status. The record does not report adjustment variables, matching procedures, or other methods for addressing differences between panels. This does not show that any particular bias occurred; it means the available record does not permit an assessment of how such differences were handled.
Why does over-dispersion matter?
In general, over-dispersion occurs when observations vary more than a statistical model expects. If it is present and ignored, standard errors and confidence intervals can be misleading. The relevance of over-dispersion depends on the outcome and model; it is often discussed for count outcomes, whereas this trial’s primary outcome is a continuous pharmacokinetic measure. The registry record does not report a model or diagnostics that would allow assessment of dispersion assumptions for the primary endpoint. This general concept should not be read as evidence that over-dispersion affected this study.
What can planning illustrations tell readers?
In general, sample-size planning uses assumptions about an effect, variability, significance level, allocation, and analysis method to illustrate how many participants might be needed for a future study. A planning calculation based on an observed effect is retrospective as an input but remains an illustration of a hypothetical design; it is not observed power and does not show the probability that the completed study detected an effect. The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also says the effect to detect is expressed as a stated fraction of the observed effect. The numerical illustrations and the observed endpoint effect are not reported in the registry record. The record does not report that these assumptions were the basis for the original trial’s enrollment target.
For time-to-event outcomes, some planning methods use event counts; for other outcomes, a planning display may express participants per arm. Those general conventions do not change the fact that planning numbers are hypothetical requirements under assumptions, not outcomes observed in this study. No planning number can fill the gap left by absent primary estimates or confidence intervals.
Finally, analysis populations matter. The primary endpoint description says that participants who were treated and complied with the protocol sufficiently to ensure the data were likely to exhibit treatment effects according to the underlying scientific model were included. This is a description of an analysis population, but the registry record does not report the number included in that population, the exclusions applied, or how deviations and missing samples were handled. Those details are necessary for assessing how the analyzed data relate to the enrolled groups.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies seven outcome measures and two analyses. It names AUC0-24 as the primary endpoint, but does not report a full hierarchy for the other measures, the relationship between the two analyses, or a strategy for controlling the chance of false-positive findings across multiple outcomes or tests. The registry record does not report whether any adjustment for multiplicity was planned or applied.
In general, multiplicity arises when several outcomes, comparisons, or analyses are examined. Without an appropriate strategy, interpreting each result independently can overstate the strength of evidence. This general concern does not imply that any reported result is false; it means readers need the analysis plan to understand how the findings were selected and interpreted. Because numerical results and detailed analysis methods are not reported in the registry record, the effect of multiplicity on this study’s interpretation cannot be assessed.
The primary population is described as treated participants who complied sufficiently with the protocol for their data to be likely to exhibit treatment effects according to the scientific model. The registry record does not report the number analyzed, how protocol compliance was defined, or which participants were excluded. It also does not report missing-data rates, reasons for missingness, methods used to handle missing samples or measurements, or sensitivity analyses.
In general, missing data can affect an estimate when the likelihood of missingness is related to participant characteristics or outcomes. The extent and direction of any effect depend on why data are missing and on the analysis assumptions. No conclusion about missing-data bias can be made from the registry record. These reporting gaps limit assessment of analysis-population selection, completeness of the endpoint data, and robustness of the primary comparison.
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 |
|---|---|---|---|
| Panel A: Severe Renal Impairment Participants | 3 | 15 | 20.0% |
| Panel B: Healthy Participants | 0 | 12 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Panel A: Severe Renal Impairment Participants | 0 of 15 |
| Panel B: Healthy Participants | 0 of 12 |
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 |
|---|---|
| Panel A: Severe Renal Impairment Participants | 4 of 15 |
| Panel B: Healthy Participants | 2 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Panel A: Severe Renal Impairment Participants | Panel B: Healthy Participants |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 1 of 15 | 0 of 12 |
| Diastolic dysfunction | Cardiac disorders | 1 of 15 | 0 of 12 |
| Influenza | Infections and infestations | 1 of 15 | 0 of 12 |
| Pneumonia | Infections and infestations | 1 of 15 | 0 of 12 |
| Hyponatraemia | Metabolism and nutrition disorders | 1 of 15 | 0 of 12 |
| Acute kidney injury | Renal and urinary disorders | 1 of 15 | 0 of 12 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 12 |
| Hypertensive urgency | Vascular disorders | 1 of 15 | 0 of 12 |
| Hypotension | Vascular disorders | 1 of 15 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Panel A: Severe Renal Impairment Participants | Panel B: Healthy Participants |
|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 1 of 15 | 0 of 12 |
| Diarrhoea | Gastrointestinal disorders | 1 of 15 | 0 of 12 |
| Vomiting | Gastrointestinal disorders | 1 of 15 | 0 of 12 |
| Urinary tract infection | Infections and infestations | 0 of 15 | 1 of 12 |
| Metabolic acidosis | Metabolism and nutrition disorders | 1 of 15 | 0 of 12 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 15 | 0 of 12 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 15 | 1 of 12 |
| Anxiety | Psychiatric disorders | 1 of 15 | 0 of 12 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 12 |
Serious events with the highest arm-level rate: acute myocardial infarction (6.7%), diastolic dysfunction (6.7%), influenza (6.7%), pneumonia (6.7%), hyponatraemia (6.7%).
The registry reports serious adverse events for the two panels. In the severe renal impairment panel, 3 of 15 participants at risk had a serious adverse event; in the healthy panel, 0 of 12 participants at risk had one. Deaths were reported as 0 in both panels. These are descriptive counts from this study, not estimates from a randomized comparison.
The record lists Acute myocardial infarction, Diastolic dysfunction, Influenza, Pneumonia, Hyponatraemia, and Acute kidney injury among the top serious event terms, each at 6.7%. The record does not provide further context for these terms in the information, such as timing, participant-level overlap, or a detailed assessment of relatedness. The percentages should be read as registry-reported figures and not converted into additional counts.
For other adverse events, the registry reports 4 of 15 participants at risk in the severe renal impairment panel and 2 of 12 in the healthy panel. The registry’s serious-event counts and other adverse-event counts are separate entries; they should not be added together or treated as mutually exclusive without further information.
In general, adverse-event summaries describe events observed and recorded during a study. In a non-randomized study with different participant groups, these counts do not by themselves establish that enlicitide caused an event or that event frequency differs because of renal status. The registry record does not report a comparative safety analysis or detailed event narratives.
12. What the Result Does, and Does Not, Mean
This study addresses a focused pharmacokinetic question: how enlicitide exposure over 24 hours compares between participants with severe renal impairment and healthy participants after repeated daily dosing. The primary endpoint, AUC0-24, is appropriate to the stated question because it summarizes plasma exposure across the interval of interest. The Day 28 assessment follows 28 days of once-daily dosing.
The registry’s brief summary says the researchers expected total exposure to be similar in the two groups. That expectation should not be mistaken for a result. The registry record does not report the primary geometric means, their 95% confidence intervals, or a numerical comparison. It therefore cannot show whether the observed estimates were similar, how large any difference was, or how precise the estimates were.
Even with numerical estimates, a conclusion about similarity would require a clear interpretation framework. In general, a confidence interval can show the uncertainty around a comparison, while a prespecified margin can define what differences are small enough to be considered acceptably similar. The registry record does not report such a margin or the relevant interval. It also does not report the detailed statistical model or adjustment methods.
The comparison is non-randomized, and the panels differ by renal status. Consequently, the design does not provide the same basis for causal group comparisons as random allocation. The record does not provide enough detail to determine how the groups’ other characteristics were addressed. This limitation does not negate the study’s pharmacokinetic purpose, but it matters when interpreting group differences.
The record also does not establish effects on LDL-C, clinical outcomes, or long-term health. It describes a pharmacokinetic study and records serious adverse events, but does not provide evidence for a clinical benefit or a comprehensive assessment of longer-term outcomes. The safety counts should be understood as descriptive observations in the study groups, not as proof of causation or as a definitive comparison of risk.
In short, the registry record identifies the study question, endpoint, design, and some safety counts, but does not report the primary endpoint results needed to answer its central exposure-comparison question. No conclusion about the amount or similarity of enlicitide exposure can be drawn from the stated expectation alone.
13. Why This Trial Matters Statistically
Renal impairment can be relevant to pharmacokinetic research because studies may ask whether drug exposure differs across groups with different kidney function. This trial addresses that kind of question by comparing plasma enlicitide exposure in participants with severe renal impairment and healthy participants. The design is focused on pharmacokinetics rather than on clinical efficacy.
Statistically, the study highlights the distinction between a research hypothesis and an observed estimate. The registry states that researchers expected similar total exposure over 24 hours, and it identifies AUC0-24 as the primary measure. But without the group estimates and confidence intervals, readers cannot evaluate the direction, size, or precision of the observed comparison. A clearly stated question and endpoint are important, but they do not substitute for reported results.
The study also illustrates why design details matter. Allocation was non-randomized, and participants were grouped by renal status. Any interpretation of a group comparison needs to recognize that the groups are not randomized controls. The registry record does not report enough detail to determine how other differences between groups were handled, which makes careful reporting of methods and analysis populations particularly important.
Reporting of uncertainty is equally central. A geometric mean and 95% confidence interval are named as the primary summary, but their values are not reported. A confidence interval would help readers judge precision; a prespecified similarity criterion would help connect the estimate to the study’s stated expectation. The registry record does not provide either the interval or such a criterion.
Finally, planning illustrations based on an observed effect should not be confused with evidence that a study was adequately powered or that an effect was detected. They describe hypothetical future sample sizes under assumptions. The study’s statistical contribution can be judged only with its actual endpoint estimates, analysis methods, and relevant limitations available. The registry record gives a useful outline of the intended comparison, but it leaves these key result and method details unreported.
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 largest limitation for interpreting the central question is that the registry record does not report the primary AUC0-24 estimates or their 95% confidence intervals. Without these, the degree of exposure in either panel, the size and direction of the comparison, and its precision cannot be assessed. The stated expectation that exposure would be similar is not a substitute for the observed results.
The non-randomized design also limits direct comparison. The panels were defined by renal status, and the record does not describe adjustment for other participant characteristics, matching, or an analysis intended to address potential group differences. It is not possible to determine from the registry record whether or how these factors influenced the comparison.
The primary endpoint description specifies a treated, protocol-compliant analysis population, but does not report how many participants were included or the operational rules for inclusion. The record does not describe missing samples, endpoint exclusions, protocol deviations, or sensitivity analyses. These omissions make it difficult to assess how representative the analyzed data were of the enrolled participants or how robust the endpoint estimate would be.
Other important statistical details are not reported in the registry record, including the full analysis plan, the method used to calculate AUC, the form of the between-group comparison, and the criterion for interpreting similarity. The record lists multiple outcomes and analyses but does not describe multiplicity handling. It also does not report a sample-size justification for the original design.
The safety reporting is limited to counts, listed event terms, and percentages. The registry record does not provide detailed narratives, timing, relatedness assessments, or a comparative safety analysis. Because the study is non-randomized, the reported counts should not be interpreted as a causal contrast between the groups.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) — NCT06643377.
- Registry record last updated 2026-10-20; status last verified 2026-07.
- Results first posted 2026-10-20.
- 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
NCT06643377 is a completed Phase 1, open-label, multiple-dose pharmacokinetic study of enlicitide in participants with severe renal impairment and healthy participants. The study used non-randomized allocation and a parallel model. Participants in each panel received enlicitide once daily for 28 days. Enrollment was 27.
The primary endpoint was plasma AUC0-24 on Day 28, summarized as a geometric mean with a 95% confidence interval. Sampling was scheduled predose and at 1, 3, 8, and 24 hours postdose. The registry record does not report the primary estimates or their confidence intervals, so the central comparison cannot be evaluated from the record.
The record reports serious adverse event counts, other adverse event counts, and no deaths in either panel. It lists seven outcome measures and two analyses, but does not report a full statistical plan, missing-data handling, or multiplicity strategy. The sponsor is Merck Sharp & Dohme LLC. The study began on 2024-11-22, reached primary completion on 2025-06-25, and is listed as completed.