A Study of CIN-107 in Patients With Uncontrolled Hypertension: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of CIN-107 in Patients With Uncontrolled Hypertension (NCT05137002), a randomized phase 2 study. The primary outcome is Change From Baseline in Mean Seated Systolic BP (SBP).

2. Clinical Question

The trial asked whether once-daily baxdrostat, given alongside participants’ usual antihypertensive medicines, was associated with a different change in mean seated systolic blood pressure (SBP) over 8 weeks than placebo in patients with uncontrolled hypertension. The primary endpoint was the change from baseline in mean seated SBP at the end of that period. Separate dose groups received CIN-107 0.5 mg, CIN-107 1 mg, or CIN-107 2 mg; each was compared with placebo.

The registry describes a further Part II option for qualified participants after the first 8 weeks. That period involved 2 mg baxdrostat for 4 weeks while background antihypertensive medication was discontinued. The primary endpoint, however, concerns Part 1 at 8 weeks, not that later period. The registry record reports an enrollment of 249, but the number analyzed for the primary endpoint differs by group and is stated with the outcome results.

3. Trial Design

This was a Phase 2, randomized, multicenter, parallel-group study with quadruple masking and placebo control. The registry lists 249 participants enrolled and the study status as completed. The record gives a study start date of 2021-12-07 and a primary completion date of 2022-09-13. It identifies CinCor Pharma, Inc. as the sponsor.

Participants were assigned to placebo or one of three CIN-107 dose groups: 0.5 mg, 1 mg, or 2 mg. During the 8-week primary treatment period, participants continued their background antihypertensive regimens. The primary endpoint was assessed at 8 weeks. The primary analysis population is described as modified intention-to-treat. Four participants discontinued Part 1 early, but their early-termination visits fell within the Week 8 analysis window and were included in that population.

The registry also describes a possible second part for qualified participants. Depending on the assigned group and blood-pressure control, participants could receive 2 mg CIN-107 for 4 weeks while stopping background antihypertensive agents, or could withdraw from study participation. This later period is distinct from the placebo-controlled primary comparison and should not be blended with the 8-week Part 1 results.

The registry record does not report the sequence-generation procedure, allocation concealment details, the specific masking roles, or a full protocol for the second part. It also does not report the trial’s original sample-size justification, its prespecified statistical analysis plan, or whether any interim analyses were planned or conducted. Randomization and quadruple masking describe important design features, but do not by themselves answer those unreported procedural questions.

4. Participant Flow and Accounting

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

Before assignment: A Run-In Period up to 4 weeks before randomization, to confirm the patient's adherence to their background antihypertensive medication(s) and placebo was done. A total of 631 patients were screened for the study, of which 382 (60.5%) patients failed the screening. Two hundred forty-nine patients were randomized to 1 of the 4 treatment groups.

Part I (8 Weeks)

Part II (4 Weeks)

Analysis population for the primary outcome, as defined in the registry: mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window.

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 Change From Baseline in Mean Seated Systolic BP (SBP), measured over 8 weeks.

The primary endpoint is the change from baseline in mean seated systolic blood pressure after 8 weeks, measured in mmHg. A change score expresses how a participant’s measured value at follow-up differs from that participant’s starting value. A negative change indicates a lower follow-up value than baseline. The registry reports least-squares means for the groups, together with standard errors.

SBP is the upper value in a blood-pressure reading. Using change from baseline makes the comparison about movement over the treatment period rather than about a single follow-up measurement alone. Comparing changes between randomized groups helps account for starting values in the analysis, although the detailed adjustment model is not reported in the registry record. The endpoint is continuous, so the reported group results describe average changes and do not show how every individual participant changed.

The endpoint was assessed at 8 weeks, matching the stated primary objective for Part 1. It was measured while participants remained on their background antihypertensive medication. Therefore, the primary comparison concerns the added treatment strategies in that setting; it does not isolate treatment without background medicines. The registry record does not report a threshold defining a clinically important difference in SBP, so statistical estimates alone cannot establish how meaningful a particular difference would be in clinical terms.

7. Results Posted in the Registry

• CIN-107 0.5 mg: mean -17.00 versus -16.60 on control; difference -0.40 (95% CI -4.85 to 4.05), standardized effect d = -0.03; z-test p = 0.860.
• CIN-107 1 mg: mean -16.00 versus -16.60 on control; difference 0.60 (95% CI -3.84 to 5.04), standardized effect d = 0.05; z-test p = 0.791.
• CIN-107 2 mg: mean -19.80 versus -16.60 on control; difference -3.20 (95% CI -7.71 to 1.31), standardized effect d = -0.26; z-test p = 0.164.

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.

Change From Baseline in Mean Seated Diastolic BP (DBP)

• 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 errors.
• Result:
  • CIN-107 0.5 mg: mean -5.80 versus -5.90 on control; difference 0.10 (95% CI -3.18 to 3.38), standardized effect d = 0.01; z-test p = 0.952.
  • CIN-107 1 mg: mean -5.00 versus -5.90 on control; difference 0.90 (95% CI -2.37 to 4.17), standardized effect d = 0.10; z-test p = 0.590.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CIN-107 0.5 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CIN-107 1 mg and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline in 24-hour Urine Aldosterone

• 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 errors.
• Result:
  • CIN-107 0.5 mg: mean -114.16 versus -19.90 on control; difference -94.26 (95% CI -178.14 to -10.38), standardized effect d = -0.42; z-test p = 0.028.
  • CIN-107 1 mg: mean -140.45 versus -19.90 on control; difference -120.55 (95% CI -202.58 to -38.52), standardized effect d = -0.54; z-test p = 0.004.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for CIN-107 0.5 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for CIN-107 1 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in 24-hour Serum Aldosterone

• 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 errors.
• Result:
  • CIN-107 0.5 mg: mean -2.76 versus -0.70 on control; difference -2.06 (95% CI -3.42 to -0.70), standardized effect d = -0.56; z-test p = 0.003.
  • CIN-107 1 mg: mean -2.95 versus -0.70 on control; difference -2.25 (95% CI -3.63 to -0.87), standardized effect d = -0.61; z-test p = 0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for CIN-107 0.5 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for CIN-107 1 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes extend the assessment beyond seated SBP to seated diastolic blood pressure (DBP), urine and serum aldosterone, the percentage reaching a seated SBP threshold, and urine and serum renin. The posted secondary results show changes in both blood-pressure measures and aldosterone measures, while the outcomes listed for renin and the threshold-based SBP response do not have results reported in the registry record. The secondary estimates therefore give an incomplete picture of the full set of outcomes named in the record.

At a broad level, the secondary results do not resolve the uncertainty in the primary SBP comparison. They offer additional descriptions of biological and blood-pressure measures, but they are not substitutes for the primary endpoint or independent confirmation of its treatment contrast. Differences across measurements can reflect that endpoints capture distinct aspects of physiology, have different variability, or use different analysis samples. The registry record does not provide a unified model that would allow those outcomes to be combined into a single treatment effect.

Unadjusted secondary p-values carry less weight because several outcomes and dose comparisons create multiple opportunities for apparently notable findings. Without a reported multiplicity strategy, the nominal p-values do not control the overall chance of false-positive findings across the family of tests. Secondary outcomes can be useful for describing patterns and generating hypotheses, but their interpretation should remain exploratory unless the analysis plan and error-control approach are known.

The registry lists six secondary outcome measures, while results are posted for only some of them in the record used for this statistical reading. It does not report why results are absent for the remaining measures, whether those outcomes were analyzed but not posted, or whether any secondary analyses were prespecified as confirmatory. Their absence should not be interpreted as evidence of no change. Overall, the secondary material provides context around the primary result, but does not remove its uncertainty or support conclusions beyond the outcomes and analyses actually reported.

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

• Change From Baseline in Mean Seated Diastolic BP (DBP)
• Change From Baseline in 24-hour Urine Aldosterone
• Change From Baseline in 24-hour Serum Aldosterone
• Percentage of Patients Achieving a Mean Seated SBP <130 mmHg
• Change From Baseline in 24-hour Urine Renin
• Change From Baseline in 24-hour Serum Renin

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a measured quantity, expressed in mmHg, rather than a category such as response or no response. The registry reports least-squares mean changes and standard errors. A least-squares mean is an analysis-based group mean, often adjusted for terms in a statistical model. The registry record does not identify the model terms or give enough detail to reconstruct the sponsor’s full analysis.

What does the mean difference represent?

The treatment-versus-placebo contrasts in the statistical reading are unadjusted recalculations from the posted group summaries. They express the treatment-group mean change minus the placebo-group mean change. A negative contrast indicates a more negative average change in the treatment group; a positive contrast indicates a less negative average change. These are comparisons between group averages, not estimates of an individual participant’s response.

Because the posted standard errors are not standard deviations, the recalculation uses an approximate conversion to obtain pooled variability. The resulting standard deviations are estimates, not participant-level measurements. Consequently, the recalculated contrasts, confidence intervals, and p-values are approximate and unadjusted. No discrepancy is flagged between those calculations and the posted results, but the registry record does not include a sponsor-reported formal analysis for these comparisons. Any sponsor analysis, if available outside this record, would be the relevant source for the prespecified inferential result.

How should a standard error be read?

A standard error describes the precision of an estimated mean: smaller standard errors indicate less sampling uncertainty around that estimate, while larger ones indicate more. It is not the spread of individual participant outcomes. Standard deviations describe participant-level variability; standard errors describe uncertainty in an estimated statistic. Converting one to the other requires assumptions about the sample and analysis. Here the conversion is approximate because the posted summaries are least-squares means with standard errors rather than raw observations and standard deviations.

What does a confidence interval add?

A confidence interval gives a range of values reasonably compatible with the estimate under the calculation and its assumptions. A wider interval indicates less precision. For a treatment contrast, an interval that includes zero is compatible with a range of positive and negative differences, including no difference. This does not make every value in the interval equally likely, nor does it mean there is a stated probability that the true effect lies in that particular interval. The intervals in this statistical reading are recalculated from summaries and are not identified as sponsor-reported intervals.

What does a p-value say?

A p-value measures how surprising data at least as extreme as the observed data would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The p-values accompanying the recalculated comparisons are unadjusted. Since the record lists multiple doses and multiple outcomes, those values should not be treated as if they account for all opportunities to find a small p-value. The registry record does not report a multiplicity procedure for these results.

Why can over-dispersion matter?

Over-dispersion is a general issue for count or binary data when observations vary more than a simple model assumes. If a model underestimates variability, standard errors can be too small and intervals too narrow. It is not the main issue for interpreting this continuous blood-pressure endpoint, for which the stated concern is instead that variability has been approximated from standard errors. The registry record does not describe a model-based over-dispersion assessment for the primary endpoint.

Randomization supports comparison of assigned groups by reducing systematic differences on average, while masking can reduce some forms of behavior or assessment bias. Neither feature removes uncertainty from finite sample sizes, missing outcomes, or analytic choices. The details needed to judge the original analysis model, missing-data assumptions, multiplicity handling, and any interim monitoring are not reported in the registry record. Accordingly, the numerical comparisons should be understood as descriptive, unadjusted recalculations rather than a complete reconstruction of the trial’s analysis plan.

11. Confidence Intervals and Precision

The precision of the primary comparison is best judged from the confidence intervals, not from the group means alone. For CIN-107 0.5 mg versus placebo, the recalculated estimate was -0.4 mmHg, and its 95% confidence interval extended from -4.849 to 4.049. For CIN-107 1 mg, the estimate was 0.6 mmHg, with an interval from -3.835 to 5.035. For CIN-107 2 mg, the estimate was -3.2 mmHg, with an interval from -7.706 to 1.306. All three intervals include zero and allow for differences in either direction.

The interval for the 2 mg comparison is consistent with a more negative change than placebo, but it also includes values close to no difference and a positive contrast. The intervals for 0.5 mg and 1 mg likewise cover both negative and positive differences. This width means the estimates are not highly precise enough to pin down a narrow range of treatment-versus-placebo differences. It does not mean the effects are necessarily equal, nor does interval inclusion of zero prove absence of an effect.

These intervals are approximate recalculations using posted means, sample sizes, and standard errors. The pooled variability was estimated from the standard errors, rather than calculated from raw participant-level data. The record does not post sponsor-reported confidence intervals for the primary comparisons. The displayed precision therefore depends on the recalculation assumptions and should not be confused with a full model-based uncertainty analysis.

Precision also depends on what effect is important for the research question. The registry record does not report a threshold for a clinically important SBP difference, so the interval cannot be classified against such a threshold. It describes statistical uncertainty in the contrast, not the practical value of each possible contrast. A more precise estimate would narrow the range of compatible differences, but the direction and interpretation still require the clinical context and a prespecified decision standard.

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 planning figures are participants per arm for the continuous outcomes, not total events. They are planning illustrations calculated from the observed effect, rather than the trial’s original design assumptions. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect. The original trial’s own sample-size justification is not reported in the registry record.

The 80% power column gives the estimated participants per arm for a hypothetical two-group study to have an 80% chance of detecting the specified effect under those assumptions, if that effect were the true effect and the model assumptions held. The 90% power column gives the corresponding planning count for a 90% chance. These are design calculations for a future study, not probabilities that the current study’s result is correct or that a treatment effect exists.

Each set of planning rows considers a different fraction of the observed effect: the full observed effect, 75% of it, and 50% of it. Smaller effects are harder to distinguish from random variation, so detecting a smaller effect requires more participants under otherwise unchanged assumptions. That pattern is visible across the planning figures. Where an observed difference is close to zero, calculations based on that estimate can become extremely large; such values should be read as illustrations tied to an uncertain observed estimate, not as a recommended trial size.

These calculations are not observed power. They do not tell how much power the completed trial had after its results were known. They also do not include any adjustment for multiple comparisons, losses to follow-up, or other design considerations unless those are explicitly part of the stated assumptions, and those additions are not described in the registry record.

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 = -0.400; pooled standard deviation σ = 12.324.
2. n = 2 × (1.96 + 0.842)² × 12.324² / -0.400² = 14,900.7, rounded up to 14,901 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 <- -0.399999999999999                      # observed difference in means
sigma <- 12.3238095878921                     # 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(5137002)
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 = 14,901 (80% power), 19,948 (90% power)
 75% of observed effect: n per arm = 26,491 (80% power), 35,463 (90% power)
 50% of observed effect: n per arm = 59,603 (80% power), 79,792 (90% power)
power.t.test: 14901.7 
Simulated power at n = 14,901 per arm: 0.801 (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. Multiplicity, Missing Data and Analysis Populations

The study considered several dose groups and multiple outcomes. Each additional comparison creates another opportunity for a small p-value to appear by chance, even if there is no underlying difference. Statistical procedures for multiplicity can control the overall false-positive risk, but the registry record does not report whether the trial used such a procedure, which comparisons were included in any testing family, or whether testing followed a hierarchy. The recalculated p-values described for the primary contrasts are unadjusted, and no multiplicity correction should be inferred.

The record identifies a modified intention-to-treat population for the primary endpoint and notes that four participants discontinued Part 1 early but had early-termination visits within the Week 8 analysis window. This clarifies that those participants contributed an in-window assessment to the stated analysis population. It does not fully explain how other missing measurements, if any, were handled. The missing-data proportion by endpoint, the assumptions underlying the analysis, and any imputation or sensitivity analyses are not reported in the registry record.

These details matter because results can depend on how incomplete follow-up is treated, particularly if the chance of missingness is related to outcome or treatment. General statistical practice uses prespecified methods and sensitivity checks to examine that uncertainty. The registry record does not report whether such checks were performed.

The registry does not report the full statistical analysis plan, the sample-size justification, or the presence or conduct of interim analyses. It also does not identify a sponsor-reported formal inferential analysis for the posted comparisons. Consequently, the posted group summaries allow approximate descriptive comparisons, but do not establish which analysis was designated as primary for hypothesis testing or whether any adjustments were prespecified. Those omissions limit assessment of selective reporting, testing strategy, and robustness.

15. 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: acute respiratory failure (1.7%), acute myocardial infarction (1.6%), hyperglycaemia (0.5%), dizziness (0.5%), hypertensive urgency (0.5%).

The registry lists participants with serious adverse events and other adverse events by group. For the Part 1 groups, serious adverse events were reported for 0 of 64 participants in placebo, 0 of 63 in CIN-107 0.5 mg, 1 of 62 in CIN-107 1 mg, and 1 of 60 in CIN-107 2 mg. The Part II CIN-107 2 mg group lists 3 of 213 participants with serious adverse events. These counts are descriptive and do not establish that a treatment caused an event.

The record also reports deaths: none in the placebo, 0.5 mg, or 1 mg groups; 1 in the CIN-107 2 mg group; and none in the Part II group. The registry does not provide enough detail in these figures to attribute causality. Part II is a distinct treatment period and its group count should not be combined with Part 1 counts as though all entries were independent participants in one comparison.

Serious adverse event counts are not a complete safety profile. The registry lists other adverse events separately and names serious-event terms with percentages, but these summaries do not provide full event narratives, timing, severity, exposure-adjusted rates, or comparative risk estimates. Rare-event counts in groups of this size are imprecise. The figures should be read as recorded safety summaries, not as evidence of a causal difference or as a basis for individual treatment decisions.

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

The primary outcome describes average change in seated SBP during an 8-week randomized comparison in which participants continued their background antihypertensive medications. Average SBP declined from baseline in every group. The treatment-versus-placebo estimates were small for the 0.5 mg and 1 mg comparisons, and more negative for the 2 mg comparison, but all recalculated confidence intervals included zero. These results communicate both the direction of the posted estimates and the uncertainty around them.

The findings do not establish that the groups were identical. A failure to distinguish a contrast from zero under an unadjusted test is not proof of no difference; the intervals remain compatible with a range of contrasts. Conversely, the more negative point estimate for 2 mg does not by itself establish a treatment effect or a dose-response pattern. The registry record does not post the sponsor’s formal comparative analysis or a threshold for clinical importance.

The endpoint is a group-average change, so it does not describe each participant’s experience. It also does not answer how outcomes would compare beyond the 8-week Part 1 period or under the different medication conditions described for Part II. The primary comparison was conducted while background treatment continued, so conclusions should remain within that setting and time frame.

The data do not establish long-term outcomes, effects on cardiovascular events, or the balance of benefits and harms beyond the reported safety summaries. Nor do the registry results alone establish how the findings apply to people outside the enrolled population. The record describes patients with uncontrolled hypertension despite one or two antihypertensive medications, but does not provide every eligibility criterion or detailed demographic composition in this statistical summary.

Overall, the posted results show substantial average reductions from baseline in all groups, with uncertain differences between each baxdrostat dose and placebo. That distinction between within-group change and the randomized between-group contrast is central: change in the placebo group occurred alongside the changes in the active-treatment groups, and the trial comparison concerns the difference between those changes.

17. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates why randomized comparisons should be interpreted through between-group estimates rather than by looking only at whether each group changed from baseline. All groups had negative average SBP changes, but the primary question is whether those changes differed across assigned groups. The estimated contrasts and their intervals make that distinction explicit.

The three dose comparisons also demonstrate the role of precision. A point estimate is only one summary of the evidence; its confidence interval shows how much uncertainty surrounds it. In these comparisons, the intervals include zero and span both directions. That leaves uncertainty even where a point estimate appears more favorable numerically. Reporting estimates with intervals supports a more complete reading than relying on a thresholded p-value alone.

The registry record also highlights limits that matter in clinical-trial interpretation. The outcome summaries are posted as least-squares means and standard errors, while formal sponsor comparisons, analysis-plan details, missing-data methods, multiplicity procedures, and original sample-size assumptions are not reported. Approximate recalculations can help characterize the summaries, but cannot recover those missing design and analysis details.

Finally, the study’s parallel dose groups and placebo comparator provide a structure for comparing the assigned strategies during the stated 8-week period. The additional Part II treatment arrangement is different and should be kept separate from that primary comparison. These distinctions help prevent overgeneralizing from one endpoint, one time point, or one analysis population to broader claims not supported by the registry record.

18. 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 primary comparison is available as posted group means and standard errors, but the registry record does not report sponsor-derived between-group confidence intervals or p-values for the primary endpoint. The comparisons described in the statistical reading are approximate recalculations from those summaries. The standard deviations used for that calculation are estimated from the standard errors rather than obtained from participant-level data, which limits how closely the results can reproduce a model-based analysis.

The registry does not report the full analysis model, covariates, treatment estimand, or handling of missing observations beyond the modified intention-to-treat description and the note about four early discontinuations with in-window visits. It also does not report whether the stated least-squares means were adjusted for baseline SBP or other variables. These details affect interpretation of the estimand and the robustness of the estimates.

Multiple doses and endpoints were assessed, but no multiplicity procedure is reported. The secondary registry outcomes include measures for which results are not reported in the registry record, and the reason for that absence is not given. Without a complete prespecified testing strategy, secondary p-values are best treated as exploratory, and the available results may not represent the complete outcome set.

The enrollment and primary analysis group counts differ, and the safety summaries use different denominators, including a separate Part II group. The record does not provide detailed participant flow, endpoint-specific missingness, or enough information to treat Part II as a continuation with directly comparable groups. In addition, the primary endpoint covers 8 weeks; longer-term outcomes are not reported in these results. The sample-size justification, interim-analysis plan, and clinically important difference are also not reported in the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study of CIN-107 in Patients With Uncontrolled Hypertension — NCT05137002.
• Registry record last updated 2023-08-01; status last verified 2023-07.
• Results first posted 2023-08-01.
• 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.

22. Record Summary

NCT05137002 is a completed Phase 2 randomized, quadruple-masked, parallel, placebo-controlled study of CIN-107, also called baxdrostat, in patients with uncontrolled hypertension. The primary outcome was change from baseline in mean seated SBP after 8 weeks, while participants continued background antihypertensive medication.

The posted least-squares mean SBP changes were -16.6 mmHg for placebo, -17.0 mmHg for CIN-107 0.5 mg, -16.0 mmHg for CIN-107 1 mg, and -19.8 mmHg for CIN-107 2 mg. Approximate unadjusted recalculated contrasts versus placebo had confidence intervals that included zero. The registry record does not report sponsor-derived formal comparisons for those contrasts.

Several secondary outcomes and safety summaries are also recorded. Multiplicity handling, detailed missing-data methods, the original sample-size justification, and the full statistical analysis plan are not reported in the registry record. The findings describe the posted results for the specified population and 8-week period; they do not by themselves establish clinical importance or longer-term effects.