This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007) (NCT05070390), a non-randomized phase 1 study. The primary outcome is Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05070390 |
| Phase | Phase 1 |
| Condition | Moderate Renal Impairment |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with moderate renal impairment and healthy controls. The registry defines moderate renal impairment as estimated glomerular filtration rate (eGFR) ≥30 and <60 milliliter/minute/1.73 meters squared. The primary analysis population is described as allocated participants who received study intervention and had AUC0-Inf data available.
Intervention
A single dose of enlicitide chloride 10 mg. The study was open-label, and the registry identifies enlicitide chloride as a drug intervention.
Comparator
Healthy control participants who also received a single dose of enlicitide chloride 10 mg. The allocation was non-randomized, so the groups should not be treated as randomized, like-for-like comparison arms.
Primary question
What is the area under the concentration-time curve from time zero to infinity (AUC0-Inf) for MK-0616 after dosing, as measured in participants with moderate renal impairment? The study also set out to evaluate pharmacokinetic effects against healthy matched controls, but the primary endpoint estimates and comparison results are not reported in the registry record.
The study concerned pharmacokinetics: how the body handles the study drug, as reflected by its concentration in blood over time. Its listed primary endpoint is an exposure measure rather than a clinical outcome. The registry also lists safety, tolerability, urine recovery, renal clearance, and change in free PCSK9 among its secondary outcomes. It states that there was no formal hypothesis. Accordingly, the central question is descriptive and comparative: what exposure measurements were obtained in the two groups, and how precisely do those measurements distinguish their pharmacokinetic profiles? The posted registry record does not give the primary estimates needed to answer that question.
3. Trial Design
NCT05070390 is a phase one, open-label, non-randomized clinical study. Its official title describes an evaluation of the pharmacokinetics of MK-0616 after a single dose in participants with moderate renal impairment. The registry lists the study model as sequential. It does not describe the sequence in enough detail to infer how participants entered or moved between study components.
The registry reports enrollment of 18 and identifies two panels: participants with moderate renal impairment and healthy controls. Each panel description specifies a single dose of enlicitide chloride 10 mg. The study summary describes the controls as healthy matched controls. Because allocation is non-randomized, however, the panels are not randomized treatment groups. Any observed difference between them could reflect group characteristics or other factors as well as renal status; the registry record does not report enough information to assess that possibility.
Participants and investigators were not masked. The primary endpoint used blood samples collected predose and at postdose timepoints extending to 336 hours. The study is listed as completed. The registry identifies safety and tolerability, urine recovery, renal clearance, and free PCSK9 change as secondary outcome areas.
The record does not report a formal hypothesis, a sample-size justification, or a detailed statistical analysis plan. It also does not report how matching was performed, the criteria used to select controls beyond the description of them as healthy and matched, or the operational details of the sequential model. Those omissions limit how fully the design can be evaluated from the registry record alone.
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 - Moderate Renal Impairment (RI) | Panel B - Healthy Controls |
|---|---|---|
| STARTED | 10 | 8 |
| COMPLETED | 10 | 8 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All allocated participants who received a dose of study intervention and had data available for AUC0-inf.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All allocated participants.
| Characteristic | Unit | Panel A - Moderate Renal Impairment (RI) | Panel B - Healthy Controls | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 8 | 18 | |
| Age, Continuous | Years | 66.5 (SD 5.6) | 60.4 (SD 5.0) | 63.8 (SD 6.1) |
| Sex: Female, Male: Female | Participants | 5 | 3 | 8 |
| Sex: Female, Male: Male | Participants | 5 | 5 | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 4 | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 | 4 | 13 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| 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 | 0 | 4 | 4 |
| Race (NIH/OMB): White | Participants | 10 | 4 | 14 |
| 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 Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616, measured over Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | hour*nmol/Liter |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the concentration-time curve from time zero to infinity (AUC0-Inf) for MK-0616, reported in hour*nmol/Liter. The registry defines this as the area under the drug concentration-time curve from time zero to infinity. Blood samples were scheduled predose and at postdose timepoints through 336 hours to characterize concentrations over time.
As a general pharmacokinetic concept, an area under a concentration-time curve summarizes overall drug exposure across the measured and extrapolated period. It combines information about concentration and duration, rather than focusing on a single blood draw. The “to infinity” endpoint includes an estimate of exposure beyond the last measured timepoint; the registry record does not describe the calculation details used for that extrapolation.
The endpoint is summarized using a geometric mean and a 95% confidence interval. In general, a confidence interval conveys uncertainty around an estimated quantity; it is not a guarantee that an individual participant’s exposure lies within its limits. Geometric means are commonly used for positive measurements that may be distributed asymmetrically, but the registry does not explain its choice of summary statistic.
Exposure is relevant to a pharmacokinetic comparison because it describes the amount of drug measured in circulation over time. It is not itself a direct measure of clinical benefit or harm. The registry record does not report the AUC0-Inf estimates, confidence intervals, or a numerical comparison between the panels, so the magnitude and precision of the primary endpoint cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes the question, endpoint, and study groups, but it does not report the primary AUC0-Inf results. There is consequently no posted estimate or confidence interval from which to judge the observed exposure in either panel or the precision of a difference between panels. The record states that there was no formal hypothesis, so the study should not be read as a reported test of a prespecified hypothesis.
The comparison is non-randomized. In general, random allocation helps balance participant characteristics between groups, whereas a non-randomized comparison may retain differences that influence an outcome. Here both panels received the same stated dose, but their allocation was not randomized. A difference, if reported, would therefore be a descriptive contrast between the groups, not automatically an isolated effect of renal impairment. The registry record does not provide details sufficient to assess the matching procedure or possible remaining group differences.
The primary endpoint is a pharmacokinetic exposure measure, not a patient-centered clinical outcome. The listed secondary outcomes broaden the scope to safety events, urinary recovery of drug, renal clearance, and free PCSK9 change. Their presence in the registry does not establish what was observed. Except for the adverse-event counts described in the safety reading, outcome estimates and analyses are not reported in the registry record.
The safety figures report no serious adverse events in either panel and list other adverse events for participants in both panels. These counts are descriptive. The record does not provide enough detail about event types, timing, severity within the other-event category, or causal attribution to support broader conclusions about safety. It also does not report discontinuations due to adverse events in the outcome information.
Overall, the posted information supports a description of the study structure and a limited account of adverse-event counts. It does not support an estimate of the primary pharmacokinetic contrast, a conclusion about the precision of that contrast, or a claim about clinical effects. The absence of a reported result is not evidence that the groups had the same exposure; it means the registry record does not supply the estimate needed to assess their relationship.
9. Statistical Methods Explained
What does AUC0-Inf represent?
In general, a concentration-time curve traces measured drug concentrations across sampling times. The area under that curve is a summary of exposure over the period represented by the measurements. AUC0-Inf extends the summary from time zero through an extrapolated tail beyond the last measured sample. The registry identifies this as the primary endpoint and states that blood samples were collected at predose and scheduled postdose timepoints through 336 hours. It does not report the concentration values, the resulting AUC0-Inf estimates, or the specific procedure used to estimate the tail.
Why use a geometric mean?
The endpoint is specified as a geometric mean with a 95% confidence interval. As a general statistical concept, the geometric mean summarizes positive values on a multiplicative scale and can be useful when measurements are right-skewed. A confidence interval expresses uncertainty about the estimated group quantity under the analysis method; it is not a range that contains every participant’s measurement. Without the estimates and interval limits, readers cannot judge either the scale of exposure or its precision in this study.
What makes the group comparison non-randomized?
The record labels allocation non-randomized and masking as none. In general, a randomized comparison uses a chance-based allocation process to reduce systematic differences between groups. A non-randomized comparison does not provide that protection by design. The study summary describes healthy matched controls, but the matching variables and procedure are not reported in the registry record. Thus, the comparison can be understood as a comparison between the recorded panels, while the extent to which differences can be attributed specifically to renal status remains uncertain.
How should the secondary outcomes be understood?
The registry lists adverse events and discontinuations due to adverse events, urine amount recovered over the stated collection period, fraction of dose recovered in urine, renal clearance, and percent change from baseline in free PCSK9. In general, these outcomes address distinct aspects of safety, elimination, and pharmacodynamic response. They are not interchangeable measures of exposure. Their inclusion in the outcome list does not mean that their numerical results are available; most associated estimates are not reported in the registry record.
What do the planning illustrations mean?
The planning assumptions describe illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The assumed effect to detect is expressed as a stated fraction of the observed effect. In general, such calculations describe hypothetical future-study planning under specified assumptions; they are not observed power and do not establish the design rationale for this completed trial. The registry does not report a sample-size justification for the trial itself. The actual planning-illustration values are not reported in the registry record.
The stated approach distinguishes participant counts per arm for non-time-to-event outcomes from total event counts for time-to-event calculations. This distinction reflects different units of analysis: participant totals for many outcomes and event totals in the stated time-to-event framework. The primary endpoint in this study is AUC0-Inf, not a time-to-event outcome. The registry record does not give the detailed statistical plan, analysis code, model specification, or any basis for treating a planning calculation as a result of the trial.
What can be inferred from the posted methods?
The record names a primary endpoint, its summary statistic, confidence level, sampling schedule, and analysis population. These details help identify what the investigators intended to measure. They do not reveal the observed endpoint values or establish how missing samples were handled. Nor do they establish whether analyses were adjusted for covariates, how outliers were handled, or whether any additional sensitivity analyses were performed. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 8 analyses, including one primary endpoint and multiple secondary outcome areas. It states that there was no formal hypothesis. The record does not report a multiplicity strategy, such as whether or how interpretation of multiple secondary analyses was adjusted. Without that information, readers should not assume that all listed outcomes were treated as confirmatory or that a particular error-control method was used.
The primary analysis population is described as allocated participants who received a dose of study intervention and had AUC0-Inf data available. This is a defined available-data population, not a statement that every allocated participant contributed to every outcome. The registry does not report the number with available primary endpoint data or explain how missing blood samples, incomplete follow-up, or missing secondary outcome measurements were handled. Missing-data assumptions and sensitivity analyses are not reported in the registry record.
The study is non-randomized, and the record does not describe an adjustment plan for differences between the panels. Details on covariate adjustment, protocol deviations, analysis exclusions, and handling of extreme values are also not reported in the registry record. These omissions matter because they affect how confidently the posted estimates could be interpreted, even if the results were available.
The registry gives planning assumptions for illustrative sample-size calculations but does not report the trial’s sample-size justification. Such illustrations are planning tools, not observed power and not evidence that the study was designed around a particular hypothesis. The record does not report an interim-analysis plan or a detailed statistical analysis plan.
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 - Moderate RI | 0 | 10 | 0.0% |
| Panel B - Healthy Controls | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Panel A - Moderate RI | 0 of 10 |
| Panel B - Healthy Controls | 0 of 8 |
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 - Moderate RI | 3 of 10 |
| Panel B - Healthy Controls | 2 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Panel A - Moderate RI | Panel B - Healthy Controls |
|---|---|---|---|
| Palpitations | Cardiac disorders | 0 of 10 | 1 of 8 |
| Diarrhoea | Gastrointestinal disorders | 0 of 10 | 1 of 8 |
| Axillary pain | General disorders | 1 of 10 | 0 of 8 |
| Fatigue | General disorders | 0 of 10 | 1 of 8 |
| Hypokalaemia | Metabolism and nutrition disorders | 1 of 10 | 0 of 8 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 10 | 0 of 8 |
| Dizziness | Nervous system disorders | 1 of 10 | 0 of 8 |
| Headache | Nervous system disorders | 0 of 10 | 1 of 8 |
The registry reports serious adverse events separately from other adverse events. In the moderate renal impairment panel, 10 participants were at risk for serious adverse events and none experienced one; 10 were at risk for other adverse events and 3 experienced one. In the healthy control panel, 8 participants were at risk for serious adverse events and none experienced one; 8 were at risk for other adverse events and 2 experienced one. No deaths are listed in either panel.
These are descriptive counts, not a randomized safety comparison. The panels were non-randomized, and the registry does not report event-level details, timing, severity for the other-event category, or causal assessments. It also lists discontinuation due to an adverse event as an outcome, but the corresponding results are not reported in the registry record. The absence of listed serious events in these groups should not be read as proof that serious events cannot occur; it describes only the recorded observations.
12. What the Result Does, and Does Not, Mean
This trial addresses a pharmacokinetic question: the registry identifies AUC0-Inf for MK-0616 as the primary measure after a single dose of enlicitide chloride. It also describes a group of participants with moderate renal impairment and a healthy control panel, both receiving the same stated dose. This design gives context for the intended comparison, but the primary endpoint estimates are not reported in the registry record.
As a result, readers cannot determine the observed exposure in either panel, how much uncertainty surrounded those estimates, or whether the groups’ exposure profiles differed. The absence of posted numerical results does not imply that the values were equal, nor does it imply that a difference was present. It leaves the main pharmacokinetic question unresolved in the registry record.
The available adverse-event counts offer a limited description of recorded safety events. They do not establish a general safety profile or determine whether events were caused by the intervention. Because allocation was non-randomized and masking was absent, any between-panel contrast would also need to be interpreted as an observational comparison rather than a randomized estimate of the effect of renal impairment.
The study’s stated focus is pharmacokinetics, safety, and tolerability. The primary endpoint does not directly measure a clinical benefit, and the registry record does not report clinical outcome results. The record therefore supports understanding what the study set out to measure and some of the recorded adverse-event counts, but not a conclusion about the clinical consequences of treatment.
13. Why This Trial Matters Statistically
Pharmacokinetic studies examine drug exposure, and renal function is relevant to questions about how a drug is handled by the body. This study’s registry entry identifies a specific exposure endpoint and describes a comparison involving participants with moderate renal impairment and healthy controls. Those features make the intended statistical question clear even though the primary results are not reported.
Statistically, the study illustrates why design labels matter. Non-randomized groups may differ in ways that complicate interpretation, even when controls are described as matched. The record does not identify the matching variables or provide enough information to assess residual differences. Any reported contrast would therefore require careful attention to the design rather than being interpreted automatically as a causal effect of renal status.
The entry also distinguishes the primary exposure endpoint from several secondary outcomes, including safety events and measures related to urinary recovery and renal clearance. These outcomes address different questions and may require distinct summaries. The record’s statement that there was no formal hypothesis is important context: the purpose and interpretation should not be recast as a confirmatory hypothesis test without support from the registry.
Finally, reporting the endpoint definition and analysis population is not a substitute for reporting estimates and uncertainty. Without the primary AUC0-Inf values and confidence intervals, the central comparison cannot be judged for magnitude or precision. The registry record is therefore useful for understanding the study’s structure, while remaining insufficient for evaluating its main pharmacokinetic result.
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 main limitation for interpreting this record is that the primary AUC0-Inf estimates and confidence intervals are not reported. The study’s central pharmacokinetic question therefore cannot be evaluated from the posted results. Most secondary outcome results are also not reported in the registry record.
Allocation was non-randomized and masking was absent. Although the study summary describes healthy matched controls, the registry does not report how matching was done or whether the groups were comparable on relevant characteristics. These limits constrain interpretation of any between-panel contrast and prevent treating the panels as randomized arms.
The record describes an available-data population for the primary endpoint but does not report missing-data counts or handling methods. It also does not report a detailed statistical analysis plan, multiplicity approach, sample-size justification, or interim-analysis information. The sample-size assumptions listed for planning illustrations do not establish the trial’s own design rationale or provide observed evidence about statistical power.
Safety reporting is limited to counts of participants with serious and other adverse events and deaths. Event descriptions, timing, severity details for other events, and causal assessments are not reported. Results for discontinuations due to adverse events are also not reported in the registry record. These omissions limit the scope of conclusions that can be drawn about both pharmacokinetics and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007) — NCT05070390.
- Registry record last updated 2026-08-19; status last verified 2026-07.
- Results first posted 2024-09-26.
- 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
NCT05070390 is a completed phase one, open-label, non-randomized study of enlicitide chloride in participants with moderate renal impairment and healthy controls. Both panels received a single dose of 10 mg. The primary endpoint was MK-0616 AUC0-Inf, summarized as a geometric mean with a 95% confidence interval.
The registry reports enrollment of 18 and describes blood sampling from predose through 336 hours after dosing. It states that there was no formal hypothesis. Serious adverse events and deaths were not recorded in either panel; other adverse events were recorded in both.
The primary endpoint estimates, confidence intervals, and most secondary outcome results are not reported in the registry record. The available entry therefore describes the study’s purpose and structure but does not provide the main numerical result needed to assess the pharmacokinetic comparison.