A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004) (NCT00847197), a randomized phase 2 study. The primary outcome is Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL).

2. Clinical Question

The clinical question is about a short-term change in a laboratory measure, not a clinical event or a long-term outcome. The registry also lists percent change from baseline in triglycerides as a secondary outcome. These lipid measures address different aspects of the trial's stated lipid-modifying question, but the primary endpoint is LDL-C. The record describes the trial as evaluating both lipid-modifying effect and tolerability. The posted results therefore need to be read as estimates for the recorded outcomes and timeframes, rather than as a comprehensive account of every possible benefit or harm.

3. Trial Design

The registry describes a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 study. It is listed as completed, with enrollment of 191. The record gives a start date of 2008-06 and a primary completion date of 2009-09. Participants were assigned to MK1903 or placebo, and the listed population had dyslipidemia without statin or other lipid-modifying therapy, as described in the brief summary.

The primary outcome was percent change from baseline in LDL-C, measured from baseline to Week 4. The registry reports group means and standard deviations for this continuous outcome. The posted analysis population is the Full Analysis Set, described as excluding randomized participants who did not receive at least one dose of study treatment or lacked post-randomization endpoint data. The record does not give further detail about the implementation of randomization, concealment, dosing, adherence, or visit procedures; these details are not reported in the registry record.

The primary outcome results list 112 participants in the MK1903 group and 75 in the placebo group. These are the reported group sizes for that outcome, not a statement about the original allocation plan. The adverse-event results use different at-risk counts, so those figures should be read within their own outcome context. The registry's total enrollment and the analysis-specific counts describe different aspects of the record and should not be combined into a newly calculated total.

The record lists triglyceride percent change as a secondary outcome, with a timeframe of baseline and 4 weeks. It also reports a mixed-model analysis for the primary outcome and a Wilcoxon's Rank Sum Test analysis for the secondary outcome. Details of the full statistical analysis plan, including any prespecified covariate adjustments or missing-data procedures, are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants had a 2-week placebo run-in period prior to randomization. 402 participants were screened of which 211 participants were excluded (194 participants did not meet inclusion criteria, 15 participants withdrew, 1 participant was lost to follow-up and 1 participant had an adverse event).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL), measured over Baseline and Week 4.

The primary endpoint is percent change from baseline in low-density lipoprotein cholesterol (LDL-C), with the timeframe given as baseline and Week 4. LDL-C is a continuous laboratory measure. Expressing the result as percent change places the observed change relative to each participant's baseline value, rather than describing only the final concentration. The registry identifies the group summary as a mean and reports a standard deviation to describe variation among participants.

In general, a continuous endpoint can summarize how a measurement shifts across a group and can be compared between randomized groups. The between-group contrast is important because changes observed within one group alone cannot separate treatment-period changes from changes that might also occur under the comparator condition. Here, the registry's primary question is whether the average percentage change differs between MK1903 and placebo over the recorded short-term timeframe.

The endpoint is a biomarker measure, not a direct measure of symptoms, clinical events, or long-term health outcomes. Its use aligns with the stated aim of assessing lipid-modifying effect, but the result only describes this measurement at the specified assessment. The registry record does not report additional timepoints for the primary endpoint or a clinical outcome linked to the LDL-C change.

7. Results Posted in the Registry

• MK1903: mean -0.30 versus -1.50 on control; difference 1.20 (95% CI -3.00 to 5.40), standardized effect d = 0.08; z-test p = 0.575.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percent Change From Baseline in Triglycerides (mg/dL)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • MK1903: mean -13.20 versus -2.00 on control; difference -11.20 (95% CI -22.00 to -0.40), standardized effect d = -0.31; z-test p = 0.042.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for MK1903 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry posts one secondary endpoint: percent change from baseline in triglycerides. It reports both group summaries and a rank-based sponsor analysis, while also providing an unadjusted recalculation based on group summaries. These analytical approaches summarize the data differently, so the secondary result should be interpreted within the method attached to each estimate rather than treating the estimates as interchangeable.

Across the outcomes, the primary endpoint and the secondary endpoint do not provide the same statistical picture. The primary LDL-C analyses have intervals that include no difference, whereas the reported secondary analysis has a confidence interval that does not include zero and a p-value below 0.05. This contrast does not change the identity of the primary endpoint or make the secondary result confirmatory. The secondary finding can be considered alongside the primary result, but it is not a substitute for it.

In general, multiple outcome testing raises the possibility of chance findings when many hypotheses are examined. A nominal or unadjusted p-value does not account for that multiplicity unless an adjustment is specified. The registry record does not report a multiplicity procedure or a hierarchy for the endpoints. Therefore, the secondary result carries less weight than a result from a clearly prespecified primary analysis with a documented testing strategy. The record also does not report the full set of analysis-plan details needed to judge how the secondary endpoint was prioritized.

The secondary endpoint is another laboratory measure over a short timeframe, not evidence about clinical events or longer-term outcomes. Its interpretation is limited to the recorded triglyceride measure and analysis. It does not establish a general pattern across unlisted outcomes, and the registry record does not report additional secondary results in this record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Percent Change From Baseline in Triglycerides (mg/dL)

9. Statistical Interpretation

10. Statistical Methods Explained

Two kinds of results appear for the primary endpoint: summaries for each group and a sponsor-reported comparison. The group summaries give the mean percent change and standard deviation. A mean describes the center of the observed values, while a standard deviation describes how spread out those values are around their mean. Neither summary alone gives the uncertainty in the difference between groups.

What does the recalculated comparison represent?

The unadjusted recalculation contrasts the posted MK1903 mean with the posted placebo mean. Its estimate is a mean difference of 1.2, and its 95% confidence interval runs from -3.0 to 5.4. The calculation uses the reported group summaries and is not the trial's mixed-model analysis. In general, an unadjusted comparison summarizes a difference without incorporating model-based adjustments that may have been used in a trial's primary analysis. The registry does not report enough detail to reconstruct the sponsor's model.

The unadjusted p-value is 0.575. In general, a p-value measures how compatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. A p-value also does not communicate the full range of values compatible with the data; that is one role of a confidence interval.

Why are the reported and recalculated estimates different?

The registry's primary analysis is a mixed-model analysis of mean difference in final values. It reports an estimate of 0.2, a 95% confidence interval from -3.9 to 4.3, and p=0.926. The recalculated comparison instead uses the posted group-level means and standard deviations for percent change from baseline. The estimate and uncertainty can differ because these are not the same reported analytical procedure or necessarily the same estimand. The registry does not report the full model specification, so further reconciliation is not possible from the record.

In general, a mixed model can account for relationships among repeated observations or other modeled structure, depending on how it is specified. That is a general description, not a claim about which particular terms or repeated measurements were included in this trial's model. The registry names a mixed-model analysis but does not report its full specification.

What does the secondary test summarize?

For triglycerides, the registry reports a Wilcoxon's Rank Sum Test and a median difference in final values. In general, a rank-based test compares the ordering of observations between groups rather than relying on the same mean-and-standard-deviation framework as a standard mean comparison. Its interpretation depends on the distributions being compared and the test's assumptions. The registry does not provide the underlying participant-level distributions, so the test cannot be independently reconstructed from the posted summary values alone.

The secondary outcome also has group means and standard deviations, and an unadjusted recalculation is posted alongside the reported rank-based analysis. These should not be conflated: the mean difference derived from group summaries is not the same estimand as a reported median difference from a rank-based analysis. The registry record identifies the methods and estimates but does not give additional details about the rationale for choosing the rank-based test.

How should confidence intervals be read?

In general, a confidence interval is a range generated by a statistical procedure that reflects uncertainty in an estimate. Its width depends on factors such as variability and the amount of information available. A wider interval indicates less precision than a narrower interval on the same scale. A 95% confidence interval is not a guarantee that the particular interval contains the true value, nor is it a range of individual participant outcomes. It describes uncertainty about a group-level estimate under the method used.

For the primary recalculation, the interval includes zero, as does the sponsor-reported primary interval. This indicates that both intervals include no between-group contrast as one value compatible with their respective analyses. It does not establish equivalence, because no equivalence margin or corresponding analysis is reported in the registry record.

What is and is not known about the analysis population?

The primary efficacy analysis uses the Full Analysis Set. The registry describes exclusions for failure to receive at least one dose of study treatment and lack of post-randomization endpoint data. It does not specify how partially missing repeated measures were handled, how missing values were imputed, or whether sensitivity analyses were performed. General statistical practice recognizes that missing-data assumptions can affect estimates, but the assumptions used for this trial are not reported in the registry record.

The reported primary outcome group sizes are 112 for MK1903 and 75 for placebo. Adverse-event at-risk counts are reported separately and should not be substituted for these efficacy analysis counts. Statistical methods should be interpreted in relation to the population and endpoint actually analyzed, not by assuming all reported counts refer to the same analysis set.

Finally, the registry lists an unadjusted p-value for the recalculated comparisons and reports p-values for the sponsor analyses. It does not report whether or how the trial controlled the chance of false-positive findings across multiple endpoints or analyses. That missing information matters especially when considering secondary outcomes, which are generally interpreted with greater caution when multiplicity handling is unclear.

11. Confidence Intervals and Precision

The primary unadjusted mean difference is 1.2, with a 95% confidence interval from -3.0 to 5.4. The interval spans negative and positive values and includes zero. This indicates uncertainty about both the direction and size of the unadjusted group contrast. The estimate is not precise enough to rule out a range of possible differences, including no difference, under this calculation.

The sponsor-reported mixed-model estimate is 0.2, with a 95% confidence interval from -3.9 to 4.3. This interval also includes zero. It is the interval associated with the trial's reported model-based analysis, whereas the other interval comes from a simple unadjusted recalculation of the posted summaries. Each interval should be read with its own estimate and analytical method.

In general, confidence intervals communicate uncertainty more directly than a p-value alone. Their width reflects the precision of an estimate: narrower intervals indicate greater precision, while wider intervals indicate less. A confidence interval is not a prediction interval for individual values, and it does not show the range in which most participants' changes occurred. Group standard deviations describe participant-level variability; confidence intervals describe uncertainty in an estimated group contrast.

The registry record does not report a clinically important threshold or an equivalence margin for the primary endpoint. Consequently, the intervals cannot be used to determine whether the estimated differences are clinically meaningful or to establish equivalence. They show the range of contrasts compatible with each analysis at the stated confidence level, subject to the method and assumptions used.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial's original design calculations. For these continuous outcomes, the figures are participants per arm. The registry's general planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The original trial design assumptions are not reported in the registry record.

The rows describe planning for 100%, 75%, or 50% of the observed effect. The columns give participants per arm for 80% power and participants per arm for 90% power. In plain terms, the 80% column illustrates the per-arm sample size associated with an 80% chance of detecting the specified effect under the planning assumptions if that effect is real; the 90% column uses a higher target chance of detection and therefore requires more participants for the same effect.

For the primary endpoint, the illustrations range from 2,464 participants per arm for 80% power and 3,298 for 90% power when planning for 100% of the observed effect, to 9,854 and 13,192 when planning for 50% of the observed effect. For the secondary triglyceride endpoint, the corresponding figures range from 159 and 213 at 100% of the observed effect to 634 and 849 at 50% of the observed effect. The intermediate rows plan for 75% of the observed effect, as recorded in the sample-size results.

Smaller effects are harder to distinguish from random variation and therefore require more participants under the same assumptions. These figures are not observed power: they are prospective planning illustrations calculated from the observed effects, not a measure of the probability that the completed trial detected an effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.200; pooled standard deviation σ = 15.033.
2. n = 2 × (1.96 + 0.842)² × 15.033² / 1.200² = 2,463.4, rounded up to 2,464 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.2                      # observed difference in means
sigma <- 15.0325646514492                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(847197)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2,464 (80% power), 3,298 (90% power)
 75% of observed effect: n per arm = 4,380 (80% power), 5,863 (90% power)
 50% of observed effect: n per arm = 9,854 (80% power), 13,192 (90% power)
power.t.test: 2464.4 
Simulated power at n = 2,464 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's own primary analysis is a mixed-model analysis of mean difference in final values. It reports an estimate of 0.2, a 95% confidence interval from -3.9 to 4.3, and p=0.926. This is the sponsor-reported result and should be distinguished from the unadjusted recalculation using the posted group means and standard deviations.

The recalculated primary comparison gives a mean difference of 1.2, with a 95% confidence interval from -3.0 to 5.4 and an unadjusted p-value of 0.575. Both sets of primary results have confidence intervals that include zero, but their estimates and methods are not identical. The registry does not provide the full mixed-model specification, so the difference between the two estimates cannot be fully explained from the record.

A recalculation is a simple comparison of posted summary statistics; it does not reproduce an analysis that may use additional model structure or data. The sponsor's own analysis is the trial's reported analysis and takes precedence for describing the prespecified trial result. The recalculation is useful as a transparent, independent unadjusted reference, but it is not a replacement for the reported analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary LDL-C endpoint and a secondary triglyceride endpoint, and it reports multiple analyses across these outcomes. However, a procedure for controlling multiplicity is not reported in the registry record. It is therefore not possible to determine whether the secondary p-value was adjusted for testing more than one outcome or whether the trial used a prespecified testing hierarchy.

In general, testing multiple hypotheses increases the chance that at least one result appears statistically unusual by chance. Adjustments or a clearly ordered testing plan can address this issue, but no such approach should be attributed to this trial without documentation. The unadjusted recalculations should be treated as descriptive comparisons, and the secondary result should be interpreted cautiously rather than as independent confirmation of the primary result.

The registry describes the primary efficacy population as the Full Analysis Set, excluding participants who failed to receive at least one dose or lacked post-randomization endpoint data. The record does not explain the handling of other missing observations, the assumptions used for missing data, or whether imputation or sensitivity analyses were conducted. It also does not report whether participants with partial outcome data contributed to the mixed-model analysis.

These details matter because missing-data methods can influence the population represented by an estimate and the uncertainty around it. In general, analyses may rely on assumptions about why data are missing and how observed information relates to unobserved values. The registry record does not state those assumptions for this trial, so the robustness of the estimates to missing data cannot be assessed from the posted information.

The original statistical analysis plan, including the intended multiplicity strategy, is not reported in the registry record. The available descriptions identify an analysis population and name the reported methods, but they do not provide enough detail to reconstruct every analytical decision.

16. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 2% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse-event figures report zero affected participants in both the MK1903 and placebo groups. The at-risk counts are 116 for MK1903 and 75 for placebo. The registry does not list serious adverse-event terms for these results. These are the posted serious-event counts; they do not by themselves describe the types, timing, severity, or relationship of events beyond the information in the record.

The separate other-adverse-event counts are 76 among 116 at risk in the MK1903 group and 26 among 75 at risk in the placebo group. These figures should be read as counts within their stated at-risk groups, not converted into percentages or combined with the serious-event results. The adverse-event at-risk counts differ from the efficacy group sizes, reflecting that the registry reports the outcome groups separately.

Deaths are not reported in the registry record. The listed counts alone do not establish comparative safety, and the record does not provide enough detail to characterize event duration, seriousness criteria, or causality for the other adverse events.

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

The posted results describe short-term changes in lipid laboratory measures among the trial's analysis groups. For the primary LDL-C endpoint, both the unadjusted recalculation and the sponsor-reported mixed-model analysis have confidence intervals that include zero. These estimates indicate uncertainty about the between-group contrast; they do not establish that the groups were equivalent or that the true difference was exactly zero.

The secondary triglyceride result is reported using a different statistical method and has a different pattern of uncertainty. It is a secondary result, and the registry record does not report how multiplicity was handled. It should therefore be interpreted cautiously and should not be treated as conclusive confirmation of the primary endpoint.

Neither outcome directly reports symptoms, clinical events, or long-term outcomes. The primary measure is a biomarker assessed at Week 4, and the secondary measure is reported at 4 weeks. The record does not provide later follow-up results for these measures or evidence about whether the observed changes persist.

The findings also do not describe every possible subgroup, every outcome of interest, or each participant's individual response. Group means and confidence intervals summarize data at the group level. The safety results give counts for the listed adverse-event categories, but the registry record does not report deaths or serious-event terms and provides limited information for interpreting event characteristics.

Overall, the registry supports a careful description of the estimates, methods, and uncertainty for the outcomes it lists. It does not support broader claims about clinical benefit, long-term effects, equivalence, or safety beyond the posted information.

18. Why This Trial Matters Statistically

This trial illustrates why the reported analysis and an unadjusted recalculation should be kept distinct. The group-level summaries allow a transparent mean comparison, while the registry's mixed-model analysis is the trial's own reported primary analysis. Their estimates are not identical, and the model specification is not reported in enough detail to reproduce it. Presenting both perspectives makes the distinction between a simple summary-based comparison and a model-based result visible.

It also demonstrates why an estimate should be read together with its confidence interval. A point estimate alone does not communicate the range of uncertainty, and a p-value alone does not show the size of a difference. For the primary outcome, the intervals include zero and span values in both directions, so the results do not tightly locate the contrast.

The secondary endpoint highlights the importance of outcome hierarchy and multiplicity. A nominally notable secondary result may attract attention, but the registry does not report a multiplicity strategy. Statistical interpretation therefore requires more than ranking p-values: it requires attention to the endpoint's role, analysis method, precision, and the prespecified plan.

Finally, the planning illustrations show how assumed effect size and target power influence projected sample size. They are not observed power and do not reveal the original design rationale. The record does not report the trial's original sample-size justification, which is an important distinction when using planning calculations to understand a completed study.

19. 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 registry record provides limited detail about the trial's statistical plan. It names a mixed-model primary analysis and a rank-based secondary analysis, but does not report the full model specification, covariates, or a complete prespecified analysis hierarchy. The reason for using the different secondary method is not reported in the registry record.

The original sample-size justification and original design assumptions are not reported. The available sample-size figures are planning illustrations derived from observed effects and should not be read as the trial's planned enrollment target or as observed power. The record also does not provide a documented multiplicity adjustment, making it difficult to assess the inferential status of the secondary result.

The Full Analysis Set is described with exclusions for not receiving at least one dose or lacking post-randomization endpoint data, but other aspects of missing-data handling are not reported. The record does not state whether partial observations were retained, how missing outcomes were addressed, or whether sensitivity analyses were conducted.

The primary outcome is measured over a short timeframe, and the record does not report later results for the listed lipid measures. The outcomes are laboratory measures, so these results do not directly answer questions about clinical events or long-term outcomes. The safety information gives event counts and at-risk group sizes but does not report deaths, serious-event terms, or further event characterization.

These limitations constrain interpretation of the posted estimates; they do not imply that unreported analyses or procedures were or were not conducted. They identify information not available in the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004) — NCT00847197.
• Registry record last updated 2015-12-21; status last verified 2015-11.
• Results first posted 2010-09-22.
• 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.

23. Record Summary

The registry describes a completed, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 study of MK1903 in patients with dyslipidemia who were not on a statin or other lipid-modifying therapy. The primary endpoint was percent change in LDL-C from baseline to Week 4. The Full Analysis Set was the stated primary efficacy population.

The sponsor-reported primary analysis was a mixed-model comparison of final values. The posted summary statistics also support an unadjusted recalculation, which is not the same analysis. Triglyceride percent change was listed as a secondary endpoint and analyzed using a Wilcoxon's Rank Sum Test. The registry record does not report a multiplicity procedure, original sample-size assumptions, or full details of missing-data handling.

The results should be understood as estimates of short-term laboratory outcomes with the uncertainty and limitations. The posted record does not establish long-term effects or clinical outcomes.