GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight (NCT04779697), a randomized phase 1 study. The primary outcome is Change in Craving Score.

2. Clinical Question

The question is about a measured score and its change over the treatment period. It does not directly establish how participants experienced cravings outside the questionnaire, nor does the primary endpoint itself assess weight. The registry record’s brief summary describes interest in craving, hunger, stress, and weight outcomes; the posted primary result is specifically the change in craving score. The study is listed as phase 1 and completed. These details frame the result as evidence from a particular randomized trial with a defined population, intervention, comparator, measurement, and follow-up period. The record does not report further details of eligibility or the rationale for selecting this endpoint.

3. Trial Design

The trial is listed as randomized, quadruple-masked, and parallel-group, with phase 1 status. The registry record names Yale University as sponsor and reports an enrollment of 96. The study is marked completed. Its intervention was semaglutide, described as a GLP-1 analogue, and its comparator was a placebo pen. Both arm descriptions specify weekly administration over 12 weeks; the semaglutide arm description gives a target dose of 1.2 mg.

The primary outcome was change in craving score from week 0 to week 12. The primary outcome summaries include 43 participants in each arm. The secondary food-intake outcome summaries include 38 in the semaglutide group and 37 in the placebo group. The secondary stress-score summaries include 36 and 40, respectively. These are the reported outcome-specific group counts; the record does not explain why the counts differ across outcomes or describe the analysis population used for each measure.

Random allocation is intended, in general, to reduce systematic differences between groups at assignment. Masking is intended, in general, to limit the influence of knowledge of treatment assignment on care, reporting, or assessment. Those design features do not by themselves resolve questions about missing outcome data, adherence, or the applicability of results beyond the enrolled population. The registry record does not report further operational details of the masking or allocation procedures.

The study’s duration for the assigned weekly interventions was 12 weeks. The primary outcome timeframe is the average change from week 0 to the end of treatment at week 12. The registry record does not report the original sample-size justification or the trial’s own design assumptions. The planning illustrations discussed separately are based on observed effects and should not be read as the study’s prespecified design plan.

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

5. Baseline Characteristics

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

Population: Baseline characteristics presented are for those that completed.

6. Primary Endpoint

The registry lists the primary outcome as Change in Craving Score, measured over Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0..

The primary endpoint is change in the average Food Craving Inventory-Revised score, abbreviated FCI-R, from week 0 to week 12. The record describes the FCI-R as a validated, revised questionnaire with 28 items about how often participants experienced cravings for different food types. Each item can be scored from 1, indicating not at all, to 5, indicating more than ever. The total score ranges from 28 to 140, with higher mean scores indicating greater average food craving.

The endpoint is calculated as the score at week 12 minus the score at week 0. On that definition, a negative change indicates a decrease in craving during the treatment period. This direction is important when interpreting the group means: more negative values represent a larger decrease in the measured score, not an increase. The primary result is a comparison of mean changes between the semaglutide and placebo groups.

A questionnaire endpoint offers a structured way to measure a participant-reported experience across a specified set of items and time period. In general, using a validated measure can support consistent interpretation, but a score remains a measure of the construct captured by that instrument. It is not a direct measure of every aspect of eating behavior, food intake, stress, or weight. The registry record does not report additional details about how the FCI-R was administered or how incomplete questionnaires were handled.

7. Results Posted in the Registry

• GLP-1a: mean -0.70 versus -0.30 on control; difference -0.40 (95% CI -0.62 to -0.18), standardized effect d = -0.78; z-test p = <0.001.

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 Food Intake - Real-World

• 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:
  • GLP-1a: mean -485.70 versus -124.50 on control; difference -361.20 (95% CI -642.38 to -80.02), standardized effect d = -0.58; z-test p = 0.012.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for GLP-1a than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Stress Score

• 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:
  • GLP-1a: mean -2.80 versus -1.70 on control; difference -1.10 (95% CI -4.54 to 2.34), standardized effect d = -0.14; z-test p = 0.531.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between GLP-1a and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes provide a mixed pattern rather than a single consistent extension of the primary finding. The food-intake comparison points toward a greater reduction in the semaglutide group, while the stress-score comparison is less conclusive and its interval spans zero. This broad pattern is compatible with the primary craving result being more clearly separated than the stress result, but the outcomes measure different constructs and should not be treated as interchangeable measures of one underlying effect.

The secondary results are related to the trial’s broader interest in responses to food cues, food intake, stress, motivation, and weight, as described in the registry summary and title. The posted secondary outcomes specifically concern real-world food intake and stress score. They do not provide posted secondary results for every topic named in the study title or brief summary. A result for craving does not automatically establish a change in food intake or stress, and a result for either secondary measure does not redefine the primary endpoint.

Unadjusted secondary comparisons carry less weight because evaluating several outcomes can increase the chance of finding an apparently notable result by chance. In general, the interpretation depends on whether outcomes and analyses were prespecified, whether a testing hierarchy was used, and whether any multiplicity adjustment was applied. Those details are not reported in the registry record. The secondary findings are therefore most appropriately treated as contextual evidence, not as multiple independent confirmations of the primary result.

Differences in outcome-specific group counts also matter when comparing the secondary results with the primary result. The record reports different counts for the food-intake and stress summaries, but does not explain the reasons or missing-data handling. Without that information, the results can be described as posted comparisons, while the extent to which incomplete data may affect them remains uncertain.

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

• Change in Food Intake - Real-World
• Change in Stress Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary measure is continuous, and the registry identifies the reported parameter as a mean with standard deviation. A mean describes the group’s average change in score. A standard deviation describes how dispersed participant-level changes are around that group average. They answer different questions: variation among individual scores is not the same thing as uncertainty in the estimated difference between group means.

What does the mean difference represent?

The primary comparison is the mean change in the semaglutide group relative to the mean change in the placebo group. The posted group changes are -0.7 and -0.3, and the recalculated unadjusted difference is -0.4 score. Because the outcome is calculated as week 12 minus week 0, negative values indicate a decrease. A negative between-group estimate therefore indicates a larger average decrease in the semaglutide group for this score. This is a group-level contrast and does not describe how every participant changed.

What does the reported ANOVA tell a reader?

The registry reports ANOVA for the primary comparison, with a superiority analysis and p < 0.001. In general, an analysis of variance evaluates whether group means differ more than would be expected under a null model of no group difference, subject to the method’s assumptions. A p-value measures how incompatible the observed data are with that null model under the analysis assumptions; it is not the probability that the null hypothesis is true, and it does not quantify the size or practical importance of an effect. The record does not report further details of the ANOVA model, covariate adjustment, or assumptions checks.

The recalculated comparison uses the posted group means, standard deviations, and group sizes to obtain a simple unadjusted estimate and uncertainty interval. It is not an individual-participant-data analysis and does not incorporate adjustments that might have been used in the sponsor’s analysis. The registry record reports no discrepancy between the recalculation and the sponsor analysis. The sponsor’s reported analysis remains the trial’s own analysis; the recalculation offers a transparent way to inspect the group summaries.

Why do confidence intervals matter?

In general, a confidence interval gives a range of effect estimates compatible with the data and the method used, at the stated confidence level. It expresses uncertainty about the contrast, rather than the spread of individual outcomes. If an interval for a mean difference includes zero, values consistent with no group difference remain within that interval. If it lies entirely on one side of zero, the interval is inconsistent with a zero difference at that confidence level, under the analysis assumptions. The registry record does not state a confidence level for the recalculated intervals, so no level should be assumed when interpreting them.

Standard errors are another way to express uncertainty in estimates. A standard error concerns the precision of an estimated quantity, whereas a standard deviation describes outcome variability. The record reports group-level standard errors alongside the arm summaries for the recalculation. Those quantities should not be mistaken for standard deviations or for measures of clinical variability.

What does randomization contribute?

In general, randomized allocation helps make treatment groups comparable at assignment, including with respect to factors that may not have been measured. It does not guarantee that the groups will be identical, and it does not address all sources of bias after assignment. Masking can reduce some influences of treatment knowledge, but the registry record does not describe the detailed procedures or how masking was assessed. The record lists the study as quadruple-masked and parallel-group.

The primary result is based on the outcome-specific summaries reported for the two arms. The record does not identify whether the analysis was intention-to-treat, per-protocol, or another analysis population, and it does not report how missing measurements were handled. The different reported group counts for primary and secondary outcomes indicate that the outcome summaries do not all use the same counts. They do not, by themselves, explain why data are unavailable or what assumptions were used to analyze them.

How should secondary analyses be treated?

The two posted secondary outcomes are continuous measures, also reported as means and standard deviations. In general, a secondary outcome can provide context or investigate related questions, but multiple comparisons create more opportunities for chance findings. Adjustment methods, a prespecified testing hierarchy, or a clear exploratory designation can affect how secondary p-values should be interpreted. The registry record does not report a multiplicity procedure or a hierarchy for the secondary analyses. Their unadjusted results should therefore be read as supportive or exploratory evidence rather than as definitive confirmation of the primary result.

These statistical methods describe comparisons of measured outcomes, not causal certainty beyond the design and analysis assumptions. Interpretation also depends on outcome measurement, completeness of follow-up, adherence, and the population studied. Details about these matters are not reported in the registry record. The record gives a completed phase 1 randomized trial and posted group summaries, but it does not provide enough information to reconstruct every analytical decision.

11. Confidence Intervals and Precision

Precision concerns how tightly the data locate an estimated effect. The recalculated primary mean difference is -0.4 score, and its reported confidence interval has both limits below zero. That placement indicates that the interval is on the side of a greater average decrease in the semaglutide group. The interval still represents a range of plausible values under the method used; the point estimate should not be treated as exact.

For the secondary food-intake outcome, the recalculated mean difference is -361.2 Kcalories and the confidence interval ranges from -642.4 to -80.02. Both limits are below zero. For the stress score, the recalculated difference is -1.1 score and the interval ranges from -4.54 to 2.34, spanning zero. These intervals describe uncertainty in group contrasts, not the range of individual participants’ changes. The registry record does not report the confidence level for these recalculated intervals.

In general, a wider interval indicates less precision, while a narrower interval indicates more precision, all else equal. Precision is influenced by outcome variability and the amount of information available for an estimate. The reported group sizes differ by outcome, as do the standard deviations, so precision should be considered separately for each outcome rather than inferred from the primary result.

An interval that spans zero does not prove that the groups are identical; it means that the interval includes values on either side of zero under the stated calculation. An interval entirely on one side of zero does not establish clinical importance. The registry record does not report a threshold defining a meaningful change for these outcomes. Statistical precision and clinical relevance are related but distinct questions.

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 give participants per arm for the continuous outcomes. They are not totals across arms and are not total event counts. The record specifies a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect: 100%, 75%, or 50%. The trial’s original sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the illustrative number of participants per arm for a design that would have an 80% chance of detecting the specified effect, under the planning assumptions and if the assumptions hold. The 90% power column gives the corresponding illustrative number per arm for a higher chance of detecting that effect. These are planning calculations based on the observed effect, not observed power.

The rows show why the effect size chosen for planning matters. Planning to detect a smaller fraction of the observed effect requires more participants per arm than planning for the full observed effect, with the same stated significance level and power target. This relationship is a general feature of statistical planning: smaller differences are harder to distinguish from random variation and require more information. The illustrations should not be read as evidence that the trial was originally designed with those group sizes, nor as a guarantee that a future study will achieve the stated power. Actual results depend on the study population, variability, analysis, and whether the planning assumptions are met.

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 = 0.510.
2. n = 2 × (1.96 + 0.842)² × 0.510² / -0.400² = 25.5, rounded up to 26 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 <- -0.4                      # observed difference in means
sigma <- 0.509901951359279                     # 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(4779697)
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 = 26 (80% power), 35 (90% power)
 75% of observed effect: n per arm = 46 (80% power), 61 (90% power)
 50% of observed effect: n per arm = 103 (80% power), 137 (90% power)
power.t.test: 26.5 
Simulated power at n = 26 per arm: 0.793 (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 reported primary analysis is an ANOVA superiority analysis with p < 0.001. The recalculated unadjusted comparison from the posted group summaries gives a mean difference of -0.4 score and p < 0.001. The registry record does not flag a discrepancy between the posted sponsor result and the recalculation. Both results are consistent with a difference in the direction of a greater mean decrease in the semaglutide group.

The recalculation is not the same as reproducing the sponsor’s full analysis. It uses summary statistics and is unadjusted; the registry record does not give sufficient detail to identify all model terms or analysis choices in the sponsor’s ANOVA. For food intake, the sponsor reports p < 0.015 and the recalculated unadjusted p-value is 0.012. For stress score, the sponsor reports p > 0.53 and the recalculated unadjusted p-value is 0.531. These summaries are broadly consistent in their statistical direction, but they do not establish that the methods were identical.

The sponsor’s analysis is the trial’s reported analysis. The recalculation is best read as a check on the posted summary data, not as an alternative official analysis. The registry record does not report a sponsor estimate and confidence interval for the primary contrast, or the detailed model specification needed to compare every analytical feature.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when more than one hypothesis or outcome is tested. In general, conducting several tests can increase the chance that at least one result appears statistically notable even when the underlying effects are absent. Researchers may address this through an adjustment method, a prespecified hierarchy of outcomes, or by clearly treating some analyses as exploratory. The registry record lists a primary craving outcome and two posted secondary outcomes, but does not report a multiplicity adjustment, testing hierarchy, or other strategy for controlling the interpretation of multiple results.

The reported primary result has a specified primary status in the registry record. The secondary outcomes should be interpreted separately and with caution because their role in the overall testing plan is not reported. Their unadjusted p-values do not account for testing across outcomes unless a reported analysis plan says otherwise; no such plan is described in the registry record. This uncertainty does not change the values reported, but it limits how strongly the secondary results can be used to support broader conclusions.

The record also does not report the analysis population, whether participants were analyzed according to randomized assignment, or how missing outcome values were handled. The primary summaries report 43 participants in each arm, while the posted secondary summaries use different group counts. The record does not explain why these counts vary, whether data were missing, or whether exclusions occurred. It would be inappropriate to infer reasons from the counts alone.

In general, missing data can affect an estimate if the availability of measurements is related to participants’ outcomes or treatment assignment. The possible effect depends on the amount and pattern of missingness and the analysis method. The registry record does not report missingness patterns, imputation, sensitivity analyses, or other methods that would clarify this issue. The reported group summaries can be interpreted as posted, but the impact of missing data cannot be assessed from the registry information described.

The record does not report a statistical analysis plan in enough detail to determine prespecification of all comparisons, handling of protocol deviations, covariate adjustment, or interim analyses. Those matters should be considered unknown rather than assumed. In general, a complete assessment of confirmatory evidence depends on the analysis plan as well as the observed estimates and uncertainty. The absence of reported details is a limitation of the registry record, not evidence that a particular procedure was or was not used.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: chest pain (2.1%).

The registry record reports serious adverse event figures for 48 participants at risk in each arm. It reports 1 serious adverse event in the semaglutide group and 0 in the placebo group. Deaths are reported as 0 in both groups. The record also lists Chest Pain at 2.1% among the top serious terms. These are the serious-event figures as posted; they do not describe the severity, timing, relatedness, or clinical course of individual events.

For other adverse events, the record reports 39 affected participants in the semaglutide group and 32 in the placebo group, with 48 at risk in each arm. These counts are separate from the serious adverse event counts. The record does not provide additional detail about event types, event frequency per participant, or attribution to treatment.

In general, adverse-event counts require context about definitions, collection, follow-up, and exposure. The posted figures alone do not establish a causal relationship or permit a full comparative safety assessment. They should be read as registry-recorded counts rather than as a conclusion that a treatment is safe or unsafe.

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

The primary result describes a difference in average change in FCI-R craving score between the semaglutide and placebo groups over the trial’s 12-week treatment period. The posted means and recalculated contrast indicate a greater average decrease in the semaglutide group. The reported uncertainty interval lies below zero, and the primary sponsor analysis reports p < 0.001. Together, these statistics describe the direction and statistical evidence for this measured group difference in this trial.

The result does not show that every participant experienced less craving, or that the observed average change applies to every person with obesity. Group averages can coexist with individual responses that vary. The endpoint is a questionnaire score, not a direct measure of every aspect of eating behavior, food consumption, stress, motivation, or weight. The record does not report a threshold for interpreting a change as clinically meaningful.

The result also does not establish effects beyond the studied period or population. The intervention was described as weekly semaglutide with a target dose of 1.2 mg over 12 weeks, compared with a weekly placebo pen. The record does not provide evidence in this entry about longer-term outcomes or other treatment regimens. The study is listed as phase 1, and its findings should be understood in that trial context.

Statistical significance is not the same as clinical importance, certainty about every participant’s response, or proof of a mechanism. The primary comparison is one piece of evidence from a randomized, quadruple-masked, parallel-group study. The registry record does not report sufficient information about missing-data handling, analysis populations, or multiplicity procedures to resolve those aspects of interpretation. The result should therefore be read as an estimate for the posted endpoint, with uncertainty and record-level limitations, rather than as a universal conclusion.

18. Why This Trial Matters Statistically

This trial is statistically informative because it places a participant-reported craving measure within a randomized, placebo-controlled comparison. The primary endpoint has a clear direction: change is calculated as week 12 minus week 0, so a negative score change indicates reduced craving. That definition makes it possible to interpret the sign of the group contrast rather than treating a positive or negative estimate as self-explanatory.

The posted primary summaries show both the group averages and their variability, while the recalculated contrast and interval describe the between-group estimate and its uncertainty. Keeping these quantities distinct is important. An average difference addresses separation between groups; standard deviations describe variation within groups; confidence intervals address precision. A small p-value alone cannot substitute for any of these interpretations or establish the practical importance of a score change.

The study also illustrates why secondary outcomes should be considered in context. Food intake and stress are related to the broader subject of the trial but are not the same outcome as craving. Their results are not equally conclusive, and the registry record does not report a multiplicity strategy. Treating each outcome as independent confirmation would overstate what the record supports.

Finally, the outcome-specific group counts differ, and the registry record does not explain the differences or missing-data procedures. Recognizing those limits is part of sound statistical interpretation. The study can inform discussion of measured craving and related outcomes in this trial, while leaving important questions about analysis populations, missingness, clinical importance, and generalizability unresolved.

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.

Several limitations specific to this trial are not resolved by the registry record. The primary endpoint is a self-reported questionnaire score, and the record does not describe administration details, completeness of the questionnaire, or handling of incomplete responses. A score-based endpoint captures the construct represented by the FCI-R, but does not directly measure every aspect of food-related behavior.

The trial is listed as phase 1, with a 12-week treatment period. The record does not report follow-up beyond that period for the outcomes, so longer-term persistence of the observed changes cannot be assessed from these entries. It also does not report a threshold for a clinically meaningful score change, making clinical interpretation of the estimate uncertain.

Group counts vary across the primary and secondary outcome summaries. The registry record does not explain these differences, describe missingness patterns, or state how missing measurements were handled. It also does not report the analysis population or whether all analyses followed randomized assignment. These gaps limit assessment of potential bias from incomplete outcome data or exclusions.

The record does not report the original sample-size justification, detailed statistical analysis plan, multiplicity strategy, covariate adjustment, or interim analyses. The planning illustrations are based on observed effects and cannot fill those gaps. Nor does the posted information provide detailed eligibility criteria or enough information to judge how well the enrolled population represents other populations with obesity. These are limits on interpretation of the registry record, not claims about procedures that may have been conducted but are not reported.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight — NCT04779697.
• Registry record last updated 2026-02-10; status last verified 2026-01.
• Results first posted 2026-02-10.
• 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

The registry record identifies NCT04779697 as a completed phase 1 randomized, quadruple-masked, parallel-group study sponsored by Yale University. It lists obesity as the condition and describes a comparison of weekly semaglutide, with a target dose of 1.2 mg over 12 weeks, against a weekly placebo pen over 12 weeks. Enrollment is reported as 96.

The primary outcome is change in FCI-R craving score from week 0 to week 12. The posted group means show a greater average decrease in the semaglutide group, and the recalculated unadjusted contrast is -0.4 score. The sponsor reports an ANOVA superiority result with p < 0.001. Posted secondary outcomes concern real-world food intake and stress score; their evidence is mixed and their multiplicity handling is not reported.

The registry record does not report the original sample-size assumptions, missing-data methods, or analysis population. Serious adverse event and other adverse event counts are recorded, but the information does not establish causality or provide a complete safety assessment. Interpretation is therefore limited to the reported outcomes and trial context.