A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (NCT06854952), a randomized phase 2 study. The primary outcome is Percent Change in Body Weight.

2. Clinical Question

The clinical question is framed as a comparison of several doses or dosing approaches against the same placebo group. The primary outcome captures the magnitude and direction of weight change as a percentage of baseline body weight. Negative values in the posted arm estimates indicate decreases from baseline, while the placebo estimate is also negative. The comparison therefore concerns the difference between each arm’s estimated change and the placebo group’s estimated change, not simply whether an individual participant lost weight.

The registry record identifies the primary outcome timeframe as 12 weeks and the primary analysis population as intent-to-treat. It does not report further detail about which participants were included in each outcome analysis or how missing endpoint measurements were handled. Interpretation should remain tied to the studied population, dose groups, and timeframe; the record does not establish what the same comparisons would show over a longer period or in other populations.

3. Trial Design

NCT06854952 is a completed, randomized, parallel-group Phase 2 study of TERN-601 in adults with overweight or obesity. The registry describes the study as Phase 2a, multicenter, double-blind, and placebo-controlled. Masking is listed as quadruple. The recorded enrollment is 167. The study start date is 2025-03-07, and the primary completion date is 2025-08-19.

Participants were assigned to one of four oral TERN-601 regimens or matching placebo, with each regimen listed as once daily. The four active arms were 250 mg, 500 mg with slow titration, 500 mg, and 750 mg. The placebo arm received matching placebo once daily. The posted primary outcome estimates are based on arm sizes of 27, 28, 28, 28, and 26, respectively. These arm-level analysis counts need not be interpreted as the full enrollment figure: enrollment and outcome-analysis counts describe different aspects of the record.

The primary outcome was percent change in body weight from baseline to Week 12, analyzed as a least-squares mean in the intent-to-treat population. The registry also lists change in body weight in kilograms and the number of participants with at least 5% weight loss as secondary outcomes. Sponsor-reported primary comparisons used ANOVA; the posted secondary comparisons use ANCOVA for the kilogram outcome and the Cochran-Mantel-Haenszel method for the threshold outcome.

The registry record does not report the full randomization procedure, allocation ratio, planned sample-size justification, prespecified analysis details beyond the listed measures, or the handling of missing data. It also does not report the original design assumptions for power or the planned approach to multiple comparisons. Those details should not be inferred from the posted estimates or from the separate planning illustrations.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat population.

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 in Body Weight, measured over 12 weeks.

The primary endpoint is percent change in body weight from baseline to Week 12. It expresses the change relative to baseline body weight rather than in kilograms. A negative estimate denotes a decrease from baseline; a value closer to zero denotes less change in the decreasing direction. The endpoint is continuous, so it retains information about the magnitude of change rather than reducing the outcome to whether a participant crossed a threshold.

The registry reports least-squares means and standard errors for the arms. In general, a least-squares mean is a model-based estimate of a group mean. The model can account for specified features of the analysis, but the covariates and full model specification are not reported in the registry record. The reported arm estimates are therefore best read as the registry’s model-based summaries, not as raw individual participant measurements.

A percent scale can help describe change across participants whose starting body weights differ, because the change is expressed relative to each baseline. It does not, by itself, describe the distribution of individual outcomes or show how many participants achieved a particular amount of change. That is why the record also includes a threshold-based secondary outcome. The primary endpoint addresses average percentage change at a fixed follow-up point; it does not characterize the durability of change beyond Week 12, and longer-term results are not reported in the registry record.

7. Results Posted in the Registry

• TERN-601 250 mg: mean -2.11 versus -0.30 on control; difference -1.81 (95% CI -3.74 to 0.12), standardized effect d = -0.51; z-test p = 0.065.
• TERN-601 500 mg (Slow Titration): mean -3.85 versus -0.30 on control; difference -3.55 (95% CI -5.47 to -1.63), standardized effect d = -0.98; z-test p = <0.001.
• TERN-601 500 mg: mean -4.87 versus -0.30 on control; difference -4.57 (95% CI -6.50 to -2.64), standardized effect d = -1.27; z-test p = <0.001.
• TERN-601 750 mg: mean -3.31 versus -0.30 on control; difference -3.01 (95% CI -4.94 to -1.08), standardized effect d = -0.83; z-test p = 0.002.

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 in Body Weight (kg)

• 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:
  • TERN-601 250 mg: mean -2.23 versus -0.45 on control; difference -1.78 (95% CI -3.83 to 0.27), standardized effect d = -0.47; z-test p = 0.089.
  • TERN-601 500 mg (Slow Titration): mean -4.02 versus -0.45 on control; difference -3.57 (95% CI -5.62 to -1.52), standardized effect d = -0.93; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TERN-601 250 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for TERN-601 500 mg (Slow Titration) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

≥ 5% Weight Loss

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • TERN-601 250 mg: 14.8% (4/27) versus 15.4% (4/26) on control; risk difference -0.6 percentage points (95% CI -19.9 to 18.7), risk ratio 0.96 (0.27–3.45); unadjusted two-proportion z-test p = 0.954.
  • TERN-601 500 mg (Slow Titration): 39.3% (11/28) versus 15.4% (4/26) on control; risk difference 23.9 percentage points (95% CI 1.1 to 46.7), risk ratio 2.55 (0.93–7.03); unadjusted two-proportion z-test p = 0.050.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TERN-601 250 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 TERN-601 500 mg (Slow Titration) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes complement the primary percentage-change measure by describing body-weight change in kilograms and the number of participants meeting a threshold of at least 5% weight loss. Taken together, they offer two different views: a continuous measure of average change and a categorical measure of whether a specified threshold was reached. The posted kilogram estimates generally follow the direction of the primary outcome, while the threshold outcome gives a less uniform picture across the active arms.

These secondary measures should be treated as supportive rather than as substitutes for the prespecified primary endpoint. The registry posts analyses for only some of the possible arm comparisons for the secondary outcomes. The count-based outcome also contains relatively few events in the posted groups, making its estimated comparisons less precise. A threshold-based count cannot show the full degree of change among participants who do or do not cross the cutoff.

The secondary analyses are reported without information about multiplicity adjustment. When several outcomes and comparisons are examined, the chance of at least one apparently notable finding can increase unless the analysis plan addresses that issue. The registry record does not report such a plan or an adjustment. Consequently, unadjusted secondary p-values and intervals carry less inferential weight than a clearly prespecified primary analysis with a reported multiplicity strategy. The secondary findings are useful for describing the pattern of posted outcomes, but they do not independently settle the primary question or establish a broader conclusion.

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

• Change in Body Weight (kg)
• ≥ 5% Weight Loss

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it measures percent change in body weight. The registry presents least-squares mean estimates for each arm along with standard errors. A mean summarizes the central tendency of a continuous outcome, while a standard error describes the estimated uncertainty in a mean. It is not the same as the spread of individual participant outcomes. The record does not provide the individual-level distribution or a standard deviation for each arm.

What does a least-squares mean represent?

In general, a least-squares mean is an estimate produced by a statistical model. It can represent an adjusted group mean when a model includes covariates or other terms. The precise model specification determines what adjustment has been made. Although the registry identifies the primary summary as a least-squares mean and lists ANOVA for the sponsor’s comparisons, the specific model terms and covariates are not reported in the registry record. It would therefore be inappropriate to assume which baseline characteristics, if any, were included.

How should the arm comparisons be read?

The reported least-squares mean difference compares an active arm with matching placebo. A negative difference in this endpoint indicates that the active-arm estimate is more negative than the placebo estimate. The sponsor’s primary comparisons are reported using ANOVA. The posted re-calculations are explicitly simple, unadjusted calculations from the summary estimates and standard errors. They are not the sponsor’s fitted analysis and do not incorporate unreported model details.

A confidence interval gives a range of values compatible with the estimate under the assumptions of the analysis. It communicates uncertainty as well as direction: a narrower interval is more precise than a wider interval, while an interval spanning values on both sides of zero does not pin down the direction as precisely. The sponsor’s primary intervals are reported at the 90% level. General statistical interpretation of a confidence interval is conditional on the method and assumptions used to construct it; it is not a guarantee that the true value lies in the reported range.

What does a p-value tell the reader?

In general, a p-value describes how unusual data at least as inconsistent with a specified null hypothesis would be if that null hypothesis and the analysis assumptions were true. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of a difference. The sponsor reports p-values alongside estimates and intervals. The registry record does not report whether these p-values were adjusted for the several primary arm comparisons, so they should be read as reported rather than assumed to control a family-wide error rate.

Why can the re-calculation differ?

The re-calculated comparisons use posted arm estimates and standard errors to make unadjusted comparisons. The pooled standard deviations are approximate, as indicated in the calculation details. In general, reconstructing a comparison from summary statistics can differ from the sponsor’s analysis because the sponsor may use a model, variance estimate, or analysis population not recoverable from those summaries. The registry flags a discrepancy between the re-calculation and reported analysis. For that reason, the sponsor’s own analysis takes precedence; the re-calculation is not evidence that the sponsor’s methods were wrong.

How do the secondary methods differ?

For change in body weight in kilograms, the registry reports least-squares means and sponsor comparisons using ANCOVA. In general, ANCOVA models an outcome while accounting for specified covariates; which covariates were used is not reported in the registry record. For the threshold outcome of at least 5% weight loss, the sponsor used the Cochran-Mantel-Haenszel method for the reported risk differences. In general, this method can compare categorical outcomes across groups while accounting for strata, when strata are specified. The registry does not report the strata or full implementation details.

These methods address different outcome types. A continuous endpoint retains the size of change, while a threshold endpoint counts participants who meet a defined criterion. The latter can be easier to describe as a responder outcome but discards distinctions among participants who fall on the same side of the threshold. The registry’s outcome summaries and analyses should therefore be interpreted according to the measure each one represents.

11. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimate. The sponsor’s primary results include 90% confidence intervals for the mean differences from placebo. The interval for the 250 mg comparison runs from -3.4 to -0.3; the interval for 500 mg with slow titration runs from -5.1 to -2.0; the interval for 500 mg runs from -6.1 to -3.0; and the interval for 750 mg runs from -4.6 to -1.5. Each interval gives a range of plausible values under the sponsor’s analysis and its assumptions. The reported point estimate is the center of the result, but the interval conveys how much uncertainty remains.

In general, a wider interval indicates less precision and a narrower interval indicates greater precision. Precision is influenced by the amount of information available and by outcome variability, among other factors. The primary arm estimates have standard errors near 0.7, and the arm-level analysis counts range from 26.0 to 28.0. These modest arm sizes help explain why estimates should not be treated as exact, though the registry record does not report a formal precision target.

The re-calculated intervals differ from the sponsor’s reported intervals. For example, the re-calculated 250 mg interval extends from -3.735 to 0.115, whereas the sponsor’s 90% interval extends from -3.4 to -0.3. The discrepancy is material to interpretation of that comparison, so the sponsor’s own analysis takes precedence. The re-calculated bounds are an unadjusted reconstruction and should not be used to override the sponsor’s reported analysis.

Intervals also do not answer every question about reliability. The registry record does not report a multiplicity adjustment, missing-data procedure, or full model specification, all of which may affect how the estimates and uncertainty should be interpreted. Confidence intervals quantify uncertainty under an analysis; they do not remove uncertainty arising from design, analysis, or incomplete reporting.

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 illustrations express required sample sizes as participants per arm, not as total participants. The registry’s 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 set to the stated fraction of the observed effect. These are planning illustrations based on observed results, not the original trial design assumptions; those original assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions are correct. The 90% power column gives the corresponding planning figure for a 90% chance. These are design calculations, not observed outcomes and not a statement about the probability that the trial’s result is true. This is not observed power.

Rows describing 100% of the observed effect use the observed difference as the planning target. Rows for 75% or 50% of the observed effect consider smaller target differences. Smaller effects generally require more participants to distinguish them from random variation with the same chosen power and significance level. The illustrated requirements can therefore increase substantially as the target effect is reduced. For the threshold outcome, the illustrations use the observed risk difference, so the resulting sample-size figures are particularly sensitive to the observed event proportions.

The calculations are not a substitute for a prospective design rationale. The original sample-size justification, planned allocation, and design assumptions for this trial are not reported in the registry record. The planning figures should be used to understand how assumed effect size relates to sample size, rather than as evidence that the completed trial was designed to those targets.

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 = -1.810; pooled standard deviation σ = 3.575.
2. n = 2 × (1.96 + 0.842)² × 3.575² / -1.810² = 61.2, rounded up to 62 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 <- -1.81                      # observed difference in means
sigma <- 3.57468807908398                     # 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(6854952)
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 = 62 (80% power), 82 (90% power)
 75% of observed effect: n per arm = 109 (80% power), 146 (90% power)
 50% of observed effect: n per arm = 245 (80% power), 328 (90% power)
power.t.test: 62.2 
Simulated power at n = 62 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 sponsor’s primary results are reported as ANOVA least-squares mean differences with 90% confidence intervals and p-values. The simple re-calculations use the posted arm estimates and standard errors to form unadjusted comparisons. Their point estimates are close to the reported comparisons, but their intervals and p-values are not identical. This can happen when a calculation reconstructed from summary statistics does not reproduce the sponsor’s full analysis model, variance estimate, or analysis details.

The registry record explicitly indicates a discrepancy. Accordingly, the sponsor’s own analysis takes precedence for interpretation of the primary comparisons. The re-calculated estimates can serve as a basic consistency check on direction and approximate magnitude; they should not be presented as corrected sponsor results. In particular, differences in whether an interval includes zero or in the corresponding p-value should be understood in light of the fact that the calculations are not the same analysis.

The registry does not report enough detail to identify the precise source of the discrepancy. It would be speculative to attribute it to a particular covariate, missing-data method, or other model feature. The reported sponsor values are therefore the appropriate basis for describing the trial’s primary analysis, while the re-calculation remains a separate, unadjusted analytical check.

15. Multiplicity, Missing Data and Analysis Populations

The study compares four TERN-601 regimens with a shared placebo group for the primary endpoint and also reports secondary outcomes. This creates multiple opportunities for comparison. In general, when many hypotheses are tested, the chance of at least one small p-value under null effects can be higher than for a single test. A prespecified multiplicity strategy can define how to interpret the family of comparisons, for example by adjusting tests or controlling a stated error rate.

The registry record reports sponsor p-values and identifies the primary comparisons as superiority analyses, but a multiplicity procedure is not reported in the registry record. It is therefore not possible to determine from the record whether the primary comparisons were adjusted, how any adjustment would affect interpretation, or which comparisons were considered part of a single testing family. The same limitation applies to the secondary outcomes. Unadjusted results should not be treated as though they necessarily control the overall false-positive risk across all comparisons.

The primary population is identified as intent-to-treat. The record does not report how that population was operationalized for each analysis, whether all randomized participants contributed to each endpoint, or how missing Week 12 measurements were addressed. Missing-data methods matter because estimates can depend on assumptions about outcomes that were not observed. The record also does not report sensitivity analyses assessing alternative assumptions about missing observations.

The full statistical analysis plan, model terms, and original sample-size justification are not reported in the registry record. Nor is an interim analysis plan reported. These omissions limit the ability to assess whether the posted analyses follow a prespecified hierarchy or to reconstruct every decision behind the estimates. They do not by themselves establish that the analyses were inappropriate; they define what cannot be verified from the registry information.

16. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: appendicitis (3.0%), intervertebral disc degeneration (3.0%), drug-induced liver injury (2.9%).

The registry lists serious adverse events by arm as participants at risk and participants affected. The reported at-risk counts are 33 for TERN-601 250 mg, 34 for TERN-601 500 mg with slow titration, 34 for TERN-601 500 mg, 33 for TERN-601 750 mg, and 33 for matching placebo. The corresponding serious-event counts are 0, 0, 1, 2, and 0. Deaths are reported as 0 in each arm.

These are counts, not estimates of comparative risk adjusted for follow-up or other factors. The record does not report the event follow-up duration, the seriousness criteria, or a comparative statistical analysis for these counts. Small numbers of events provide limited information about differences between groups, and zero reported events in an arm does not demonstrate that the risk is absent.

The registry also lists appendicitis at 3.0%, intervertebral disc degeneration at 3.0%, and drug-induced liver injury at 2.9% among the leading serious-event terms. The record does not establish in this summary which treatment arms these terms occurred in, so no arm-specific attribution should be inferred. Safety counts describe what was posted for this trial and are not, on their own, a complete characterization of safety.

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

The primary results describe estimated average body-weight change at Week 12 in this randomized, placebo-controlled Phase 2 study. The sponsor-reported comparisons show negative differences between each TERN-601 arm and matching placebo, with the size of the estimated difference varying across regimens. The confidence intervals indicate uncertainty around those estimates, and the sponsor-reported p-values summarize evidence under the analyses used.

These findings do not establish that a particular regimen is appropriate for an individual, and they should not be read as medical advice. Nor do the posted results establish what would happen outside the study population or beyond the measured timeframe. The registry record does not report longer-term outcomes, and a 12-week endpoint cannot by itself answer questions about durability.

The reported comparisons are group-level statistical summaries. They do not show that every participant in an arm had the same experience, or that an average difference describes the full range of individual outcomes. The secondary threshold outcome provides a different summary, but it also cannot capture every aspect of weight change. Safety counts are likewise limited by the number of events recorded and by the safety details not reported in the registry record.

Interpretation is further bounded by incomplete information about multiplicity, missing-data handling, and the detailed analysis plan. The discrepancy between the sponsor’s results and simple re-calculations is acknowledged; the sponsor’s analysis takes precedence. Overall, the record supports a description of the posted estimates and their precision, not a definitive conclusion about broader effectiveness, long-term outcomes, or comparative safety.

18. Why This Trial Matters Statistically

This trial illustrates why statistical interpretation should begin with the estimand and endpoint. Percent change in body weight is a continuous measure of average change, while a threshold outcome asks whether participants met a particular criterion. Those outcomes can tell related but nonidentical stories. Considering both helps distinguish the magnitude of average change from the frequency of reaching a threshold.

The study also demonstrates the value of reporting estimates with intervals rather than focusing only on p-values. An estimated difference conveys direction and scale; an interval shows uncertainty. The sponsor results and the re-calculations are close in point-estimate terms but not identical in inferential details. Recognizing that they come from different analyses—and giving precedence to the sponsor’s reported analysis when the record flags a discrepancy—is essential to responsible reading.

Multiple doses and outcomes make transparent reporting of the statistical plan especially relevant. Without a reported multiplicity strategy, the inferential status of a collection of p-values is uncertain. Details about missing outcomes, model specification, and sample-size assumptions would also help readers assess how robustly the estimates answer the study question. The registry record does not report these details, so conclusions should stay proportionate to what is documented.

Finally, the safety results show why event counts need context. A small number of serious events, including zero in some arms, gives limited precision for comparing uncommon outcomes. The study is informative as a Phase 2 examination of several regimens over a defined period, while its estimates remain subject to uncertainty and the limits of the reported record.

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 primary endpoint is measured at Week 12. The registry record does not report later outcome results, so the posted primary estimates do not describe whether changes persisted beyond this point. The study is Phase 2a and includes several dose regimens; the record does not establish how these findings generalize beyond the enrolled adults with overweight or obesity.

Although the overall enrollment is 167, the posted primary outcome analysis counts by arm range from 26.0 to 28.0. The resulting comparisons have limited information for estimating uncommon outcomes or fine distinctions between regimens. The serious adverse-event counts are especially sparse, and the registry does not provide a comparative safety analysis or a safety follow-up timeframe in this summary.

The record identifies randomization, quadruple masking, and a parallel design, but does not report the detailed allocation process or the full analysis plan. The primary model specification and covariates are not reported. Missing-data handling, sensitivity analyses, and multiplicity procedures are also not reported in the registry record. These gaps limit independent assessment of the assumptions behind the sponsor-reported estimates.

The registry flags a discrepancy between the sponsor’s analysis and unadjusted re-calculations based on posted summary statistics. The sponsor analysis takes precedence, but the record does not explain the source of the discrepancy. Secondary results are also limited by incomplete reporting of comparisons and the absence of a reported multiplicity strategy. These limitations constrain interpretation; they do not establish that an unreported method or adjustment was not used.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity — NCT06854952.
• Registry record last updated 2026-08-10; status last verified 2026-08.
• Results first posted 2026-08-10.
• 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.

23. Record Summary

NCT06854952 is a completed randomized, parallel-group Phase 2 study of oral TERN-601 in adults with overweight or obesity. The registry describes it as multicenter, double-blind, and placebo-controlled, with quadruple masking. Four TERN-601 regimens were compared with matching placebo.

The primary outcome was least-squares mean percent change in body weight from baseline to Week 12 in the intent-to-treat population. Sponsor-reported analyses used ANOVA and included 90% confidence intervals and p-values. The registry also posts secondary outcomes for body-weight change in kilograms and at least 5% weight loss. A discrepancy is flagged between sponsor results and simple unadjusted re-calculations; the sponsor’s own analysis takes precedence.

The registry reports serious adverse-event counts and deaths by arm. Details on multiplicity, missing-data handling, full model specification, and the original sample-size rationale are not reported in the registry record. Results should be interpreted as estimates for this study population and timeframe, with the stated uncertainty and reporting limitations.