A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) (NCT05656040), a randomized phase 1 study. The primary outcome is Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE).

2. Clinical Question

3. Trial Design

This was a Phase 1 randomized, single-masked, parallel-group study sponsored by Merck Sharp & Dohme LLC. The record lists a start date of 2023-02-08, primary completion on 2024-08-12, and an overall status of completed. Enrollment was 14 participants. Part 1 evaluated a single subcutaneous dose of MK-2060 in participants with CKD4, with placebo as the comparator.

The active arm received MK-2060 30 mg on Day 1, while the placebo arm received normal saline on Day 1. The primary safety outcome listed in the registry counted participants with one or more bleeding-related adverse events, with follow-up described as up to approximately 104 days. The analysis population is described as all treated participants in Part 1. The outcome counts are 0 participants in the MK-2060 arm and 0 in the placebo arm.

The study was originally intended to have three parts. The brief summary says Part 2 was intended to evaluate multiple subcutaneous doses in CKD4 participants, and Part 3 was intended to evaluate a single subcutaneous dose in participants with end-stage kidney disease. Neither Part 2 nor Part 3 was initiated, for reasons described as unrelated to safety. Their intended evaluations therefore should not be treated as completed comparisons or as evidence about those populations or dosing schedules.

The record identifies the trial as randomized and single-masked, but the method of sequence generation, allocation concealment, and identity of the masked parties are not reported in the registry record. The planned sample-size justification is not reported in the registry record. The brief summary describes a pharmacokinetic hypothesis, while the listed primary outcome is a safety event count; results for the pharmacokinetic measure 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All treated participants in Part 1 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.

6. Primary Endpoint

The registry lists the primary outcome as Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE), measured over Up to approximately 104 days.

The listed primary endpoint is the number of participants who experienced one or more bleeding-related adverse events. It is a participant-level count: a person is counted if at least one qualifying event occurred during the stated follow-up, rather than being counted once for every separate event. The definition is broad. It includes any sign or symptom of bleeding, even if no intervention by a medical or healthcare professional was needed, as well as clinically relevant nonmajor bleeding or major bleeding.

This kind of safety endpoint is used to describe whether participants experienced an event of concern during exposure and follow-up. It is not a measure of drug concentration or of the drug’s pharmacodynamic effect. Those are separate objectives in the study description: the record lists a Part 1 pharmacokinetic hypothesis involving AUC0-inf and includes activated partial thromboplastin time (aPTT) among its secondary outcomes.

The registry lists 0 participants with the primary endpoint in the MK-2060 30 mg arm and 0 in the placebo arm. The outcome population is described as all treated participants in Part 1. The timeframe is up to approximately 104 days. Because the outcome is binary at the participant level, the posted counts describe whether participants did or did not experience at least one qualifying event; they do not describe event severity, timing, or recurrence for each participant.

Although the record defines the endpoint and gives arm-level counts, it does not report additional detail about event adjudication or a statistical comparison for this outcome. The registry record’s brief summary calls AUC0-inf the focus of the Part 1 primary hypothesis, so that pharmacokinetic objective should be distinguished from the primary outcome measure listed in the outcome results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Part 1’s listed primary outcome is binary at the participant level. Each treated participant is classified according to whether at least one bleeding-related adverse event occurred during the stated follow-up. A participant with multiple qualifying events would still count once for this endpoint, because the outcome is defined as the number of participants with one or more events. The posted arm counts are 0 of 11 for MK-2060 30 mg and 0 of 3 for placebo.

What a binary outcome can show

For a binary outcome, the observed count and group size provide a direct account of how many participants had the event in each arm. A comparative analysis can estimate how event occurrence differs between groups and quantify uncertainty around that estimate. With zero events in both arms, the posted record does not give an estimable two-arm comparison; no comparative estimate or p-value is reported. This should not be replaced by a claim that the groups are equivalent. Equivalence requires a suitable design and analysis, and those are not reported in the registry record.

General statistical point: a confidence interval describes a range of values compatible with the data and the assumptions of the analysis. For rare or unobserved events in small groups, uncertainty can remain substantial even when the observed count is zero. A confidence interval for a contrast would therefore be useful context, but the registry record does not report one for this endpoint. It also does not report a statistical test for the posted arm counts.

What the design labels mean

The record describes the study as randomized, single-masked, and parallel-group. In a randomized trial, assignment to study arms is determined by a random process; the particular sequence-generation method and allocation procedures are not reported in the registry record. Single masking indicates that masking was used, but the record does not identify which people were masked. In a parallel-group design, participants are assigned to an arm and the arms are evaluated alongside one another. The record does not specify the randomization ratio, and the treated groups are reported as 11 and 3 participants.

Random assignment can help make groups comparable on average, but it does not guarantee balance in a small study. The information does not support claims about balance on individual baseline characteristics because those details are not included in the registry record analyzed. Nor does the record describe adjustment for baseline variables, stratification, or covariate modeling.

Endpoint definitions and related outcomes

The primary outcome is not a count of all adverse events. It is a count of participants with one or more bleeding-related events under a definition that includes any sign or symptom of bleeding, clinically relevant nonmajor bleeding, or major bleeding. Separately, the safety listing reports serious adverse events, other adverse events, and deaths. Those categories should not be substituted for the primary outcome or assumed to overlap in a particular way; the record does not provide participant-level cross-tabulations.

The record lists aPTT outcomes among the secondary outcomes. It does not report numerical results for those measures in the registry record for this analysis. The study description also includes pharmacokinetics and pharmacodynamics as objectives, and the brief summary gives a Part 1 AUC0-inf hypothesis. The listed primary safety event count and that pharmacokinetic hypothesis concern different measurements. A result for the stated AUC0-inf hypothesis is not reported in the registry record.

Planning figures and analysis assumptions

The record’s planning illustration is described as using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Such calculations are planning illustrations, not trial results and not observed power. They depend on assumptions about the effect and analysis method; they do not show the probability that the trial’s result is correct. The record describes sample sizes from these illustrations as participants per arm for non-time-to-event outcomes. Because the posted binary endpoint has zero events in both groups and a two-arm comparison is marked as missing or not estimable, a planning figure based on an observed effect should not be read as evidence of a detectable treatment effect for this outcome.

The statistical analysis plan, including any prespecified estimator or model for this primary safety endpoint, is not reported in the registry record. Interim analyses, stopping rules, missing-data methods, and procedures for handling multiple outcomes are also not reported in the registry record. These omissions limit what can be concluded about how the posted results relate to a prespecified inferential plan.

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.

R code and output

arm    <- c("MK-2060 30 mg", "Placebo")
n      <- c(11, 3)
events <- c(0, 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  MK-2060 30 mg  11  0  0.0  0.0  28.5  -0.0  25.9  0.2  26.5
ARM  Placebo  3  0  0.0  0.0  70.8  0.0  56.1  0.6  60.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists three secondary outcomes, all related to aPTT: a mean fold change from baseline in Part 1, and percent change from baseline in Parts 2 and 3. The record says Parts 2 and 3 were not initiated. Numerical results for these secondary outcomes are not reported in the registry record. A multiplicity strategy—such as whether any statistical testing across outcomes was adjusted or interpreted as exploratory—is not reported in the registry record. It is therefore not possible to assess how the listed outcomes were prioritized for formal inference or whether any adjustment was planned.

The outcome population for the primary measure is described as all treated participants in Part 1. The record does not describe a separate intention-to-treat population, a per-protocol population, or rules for inclusion in any pharmacokinetic or pharmacodynamic analysis. Missing-data methods and the amount or pattern of missing outcome data are not reported in the registry record. No assumptions about how missing observations were handled should be inferred from the posted counts.

The registry provides the primary endpoint counts and group sizes, but a two-arm comparison is marked as having values missing or not estimable for a binary endpoint. It does not report an inferential estimate, confidence interval, or p-value for that comparison. The record also does not report interim analyses or a detailed statistical analysis plan. As a result, the available information supports a descriptive reading of the counts, but not a reconstruction of a broader multiplicity or missing-data strategy.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: anaemia (9.1%), cardiac failure congestive (9.1%), acute kidney injury (9.1%).

For serious adverse events, the registry lists 2 of 11 participants in the MK-2060 30 mg group and 0 of 3 participants in the placebo group. For other adverse events, it lists 5 of 11 and 2 of 3 participants, respectively. No deaths are listed in either group. These are participant counts in separate safety categories; the record does not provide participant-level detail that would show how the categories overlap.

The serious adverse-event terms named in the record are Anaemia, Cardiac failure congestive, and Acute kidney injury, each reported as 9.1%. These terms should be read as the listed event terms, not as a comparative analysis. The registry information does not provide further context about timing, duration, severity beyond the serious classification, or relatedness to study treatment for these terms.

Serious adverse events are not synonymous with bleeding-related adverse events. The primary endpoint specifically concerns bleeding, and it is reported as 0 participants in each arm. The serious-event counts do not change those primary endpoint counts. Conversely, the zero bleeding-related counts do not mean that no other adverse events occurred. The safety figures are descriptive, and the small group sizes and lack of a reported comparative analysis limit conclusions about differences between arms.

13. What the Result Does, and Does Not, Mean

The posted primary endpoint results say that no treated participant in either arm was recorded as having one or more bleeding-related adverse events during follow-up of up to approximately 104 days. This is the direct observation for the listed safety endpoint. The registry also reports serious and other adverse-event counts, which show that events in those categories were recorded, but they should not be conflated with the bleeding-specific endpoint.

The results do not establish that MK-2060 and placebo have the same bleeding-event risk. A lack of observed events in both groups is not proof of equivalence, and the record supplies no confidence interval or inferential test for the comparison. The group sizes are limited, with 11 participants receiving MK-2060 and 3 receiving placebo, so the posted counts cannot precisely characterize uncommon events. No treatment-effect estimate for the primary binary outcome is reported.

The record’s brief summary describes a Part 1 pharmacokinetic hypothesis about AUC0-inf, with a stated threshold of 11300 nM*hr. That hypothesis is not answered by the posted bleeding-event counts. The AUC0-inf result is not reported in the registry record, and numerical results for the aPTT secondary outcomes are also not reported in the registry record. Thus the listed safety counts alone cannot establish whether the pharmacokinetic or pharmacodynamic objectives were met.

The study’s intended scope was broader than its completed Part 1. The planned multiple-dose CKD4 evaluation and the single-dose end-stage kidney disease evaluation were not initiated for reasons described as unrelated to safety. There are consequently no results from those planned parts to interpret. The available evidence is limited to the recorded Part 1 groups and outcomes; it should not be generalized to unstudied dose schedules or populations on the basis of this record alone.

14. Why This Trial Matters Statistically

This trial illustrates why a clinical study’s objective, listed primary outcome, and posted analysis need to be read separately. The brief summary describes a pharmacokinetic hypothesis about AUC0-inf, while the registry’s listed primary outcome is a count of participants with bleeding-related adverse events. These measures answer different questions: one concerns drug exposure, while the other records whether a qualifying safety event occurred. A result for the pharmacokinetic hypothesis is not reported in the registry record.

It also illustrates a common limitation of small safety datasets. Zero observed events in both arms is an important descriptive finding, but it does not by itself quantify how uncertain the underlying event risks are or establish that the groups are equivalent. The record does not provide a comparative estimate or interval for the primary endpoint, and it marks the binary comparison as missing or not estimable. The appropriate statistical reading is therefore bounded by the counts rather than extended to an unsupported treatment-effect conclusion.

The study was designed as a three-part program, but only Part 1 was initiated; Parts 2 and 3 were not started for reasons described as unrelated to safety. That distinction matters when interpreting the overall study title and its intended objectives. The record’s observed results concern a single-dose CKD4 evaluation, not the planned multiple-dose or end-stage kidney disease evaluations.

Finally, the safety listings show why endpoint definitions matter. The primary outcome is specific to bleeding, whereas serious adverse events and other adverse events are broader categories. Keeping those measures distinct avoids treating all safety counts as interchangeable and makes clear both what the registry reports and what remains unanswered.

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 main limitation is the small number of treated participants, particularly in the placebo group, which contains 3 participants. With the primary bleeding-related outcome recorded as zero in both groups, the registry does not report a comparative estimate or confidence interval, and the binary two-arm comparison is marked as missing or not estimable. The observed counts therefore provide little basis for quantifying the difference between groups or the uncertainty around it.

The registry record does not report baseline characteristics, the randomization method, allocation concealment, or which parties were masked. It does not report the statistical analysis plan, missing-data procedures, interim analyses, or multiplicity handling. These gaps prevent a detailed assessment of balance between arms and of how the analyses were prespecified or carried out.

The record includes a pharmacokinetic hypothesis in its brief summary but does not report the corresponding AUC0-inf result. It lists aPTT secondary outcomes without numerical results in the registry record for this analysis. The study’s planned Part 2 and Part 3 were not initiated, so the record provides no findings from the intended multiple-dose CKD4 or single-dose end-stage kidney disease evaluations. The safety counts should be understood within those limits and the stated follow-up of up to approximately 104 days.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) — NCT05656040.
• Registry record last updated 2025-09-10; status last verified 2025-09.
• Results first posted 2025-09-10.
• 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.

19. Record Summary

NCT05656040 is a completed Phase 1 randomized, single-masked, parallel-group study of MK-2060 in participants with chronic and/or end-stage kidney disease. Part 1 evaluated a single subcutaneous dose of MK-2060 30 mg against placebo in CKD4 participants. The listed primary outcome was the number of participants with one or more bleeding-related adverse events, with follow-up up to approximately 104 days.

The posted primary outcome count was 0 of 11 participants in the MK-2060 group and 0 of 3 in the placebo group. Serious adverse events were listed for 2 of 11 and 0 of 3 participants, other adverse events for 5 of 11 and 2 of 3, and no deaths in either group. The record does not report an estimable two-arm comparison for the primary binary outcome. Parts 2 and 3 were not initiated for reasons described as unrelated to safety, and results for the AUC0-inf hypothesis are not reported in the registry record.