Lifestyle Modification and Liraglutide: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Lifestyle Modification and Liraglutide (NCT02911818), a randomized phase 4 study. The primary outcome is Percent Change in Baseline Weight.

2. Clinical Question

This is a question about differences in group averages, not about the outcome of any individual participant. The primary measure captures weight change relative to baseline over the specified follow-up. The registry record also lists secondary measures concerning blood pressure, heart rate, waist circumference, and cholesterol and triglycerides. These outcomes broaden the description of what was measured, but they do not replace the stated primary outcome.

The comparison of counseling alone with counseling plus liraglutide addresses the addition of medication within this trial’s counseling program. The comparison with the multi-component intervention concerns a package that included liraglutide and a portion-controlled diet. Because that package differs in more than one component from counseling alone, its contrast cannot isolate the contribution of the diet from the contribution of liraglutide. The posted results describe between-group averages; the registry record does not report a separate analysis that attributes effects to individual components.

3. Trial Design

The registry record describes a completed Phase 4, randomized, parallel-group, open-label, single-center trial with a 52-week main study period. Enrollment is listed as 150. The primary outcome timeframe is randomization to 52 weeks. The record gives three main groups: CMS-Alone, CMS-Liraglutide, and Multi-Component Intervention. Each group has 50 participants in the posted primary-outcome results.

CMS-Alone received lifestyle counseling as recommended by CMS. CMS-Liraglutide received the same counseling plus liraglutide 3.0mg. The Multi-Component Intervention combined the counseling and liraglutide with a portion-controlled diet, described as 1000-1200 kcal/day for 12 weeks. The summary describes 14 brief, 15 minute counseling visits during the first 24 weeks, followed by monthly visits in weeks 25-52. It also describes physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 in all main groups, with those visits included for the counseling-alone group to match the intensity of medical care.

Open-label means the main trial was not masked according to the registry record. The record lists start in 2016-09, primary completion in 2018-11, and status as completed. It also lists a 12-Week Extension Study with phentermine and placebo groups, both described as continuing liraglutide and monthly lifestyle counseling after the 1-year trial. Those extension groups are separate from the three main trial groups in the adverse-event record. Further details of extension eligibility are not reported in the registry record.

The original design’s sample-size assumptions, planned analysis model, handling of missing observations, and analysis populations are not reported in the registry record. The posted results therefore support description of the stated group summaries and simple unadjusted comparisons, but do not establish what analysis was originally planned.

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.

52 Week Study

12 Week Extension 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.

6. Primary Endpoint

The registry lists the primary outcome as Percent Change in Baseline Weight, measured over Randomization and 52 weeks.

The primary endpoint is percent change in baseline weight from randomization to 52 weeks. It expresses weight change relative to each participant’s starting weight, rather than as an absolute change in weight units. The posted outcome is a mean for each group, accompanied by a standard error. A negative mean indicates a reduction from baseline on this percent-change scale; more negative group means indicate a larger average reduction.

A relative measure can help describe change across participants whose starting weights differ. Reporting the mean also gives a group-level summary, but it does not show the range of individual responses or the proportion of participants who reached a particular threshold. The registry summary mentions secondary thresholds for weight loss, but its description is truncated and the posted primary results concern the mean percent change.

The endpoint is measured at the end of the stated main follow-up, so it captures the average change over the trial period rather than establishing what happened after that period. The clinical importance threshold for this endpoint is not reported in the registry record. The outcome should therefore be read as a statistical measure of average relative weight change, not as a stand-alone judgment about clinical importance.

7. Results Posted in the Registry

• CMS-Liraglutide: mean -11.50 versus -6.10 on control; difference -5.40 (95% CI -9.00 to -1.80), standardized effect d = -0.59; z-test p = 0.003.
• Multi-Component Intervention: mean -11.80 versus -6.10 on control; difference -5.70 (95% CI -9.30 to -2.10), standardized effect d = -0.62; 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 Systolic Blood Pressure

• 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:
  • CMS-Liraglutide: mean -13.30 versus -14.10 on control; difference 0.80 (95% CI -5.02 to 6.62), standardized effect d = 0.05; z-test p = 0.788.
  • Multi-Component Intervention: mean -15.30 versus -14.10 on control; difference -1.20 (95% CI -7.02 to 4.62), standardized effect d = -0.08; z-test p = 0.686.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CMS-Liraglutide 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 Multi-Component Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Change in Diastolic Blood Pressure

• 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:
  • CMS-Liraglutide: mean -2.90 versus -3.00 on control; difference 0.10 (95% CI -3.23 to 3.43), standardized effect d = 0.01; z-test p = 0.953.
  • Multi-Component Intervention: mean -3.50 versus -3.00 on control; difference -0.50 (95% CI -3.83 to 2.83), standardized effect d = -0.06; z-test p = 0.768.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CMS-Liraglutide 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 Multi-Component Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Change in Heart Rate

• 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:
  • CMS-Liraglutide: mean -5.30 versus -7.40 on control; difference 2.10 (95% CI -3.44 to 7.64), standardized effect d = 0.15; z-test p = 0.458.
  • Multi-Component Intervention: mean 9.70 versus -7.40 on control; difference 17.10 (95% CI 11.56 to 22.64), standardized effect d = 1.21; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CMS-Liraglutide 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 higher for Multi-Component Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry record lists secondary outcomes across blood pressure, heart rate, waist circumference, and blood lipids, and identifies 32 posted secondary outcomes. The arm-level estimates and comparisons included in the available record cover systolic blood pressure, diastolic blood pressure, and heart rate. They show that secondary outcome patterns need not move together: some comparisons are close to zero, while another has a more pronounced difference. The complete set of secondary results cannot be characterized from the information reported in the registry record.

These outcomes relate to the primary question by describing other measures collected over the same randomization-to-52-week timeframe. They may provide context about changes accompanying the weight outcome, but the posted results do not establish that weight change caused changes in blood pressure, heart rate, or other measures. Nor do the secondary measures establish a mechanism for the primary result.

Unadjusted secondary comparisons carry less weight as confirmatory evidence when many outcomes or contrasts are examined. With multiple opportunities to observe a low p-value, chance findings become more likely unless the analysis accounts for that multiplicity. The registry record does not report a multiplicity adjustment, a hierarchy of secondary hypotheses, or a statistical analysis plan. Thus, each unadjusted comparison is best treated as exploratory evidence to be interpreted with its estimate and precision, rather than as an independent definitive conclusion.

The listed 32 secondary outcomes do not imply that all had the same analysis, completeness, or evidential status. Detailed results for outcomes beyond those with arm-level estimates and comparisons are not reported in the registry record. The breadth of the outcome list is useful for understanding the trial’s measurement scope, but it does not replace complete reporting of estimates, uncertainty, and analysis methods.

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

• Change in Systolic Blood Pressure
• Change in Diastolic Blood Pressure
• Change in Heart Rate
• Change in Waist Circumference
• Change in Total Cholesterol
• Change in LDL Cholesterol
• Change in HDL Cholesterol
• Change in Triglycerides

9. Statistical Interpretation

10. Statistical Methods Explained

What does a group mean represent?

The primary result is reported as a mean, which is a summary of the group’s observed values. It provides a concise description of the average percent change in baseline weight, but it does not show how widely participants’ outcomes varied or whether the group contained distinct patterns of response. Two groups can have similar means while differing in the spread or shape of their individual results. The registry record does not provide participant-level distributions for the primary outcome.

The posted standard error describes uncertainty around an estimated group mean. It is not the same as the standard deviation of individual outcomes: the standard error concerns precision of the estimated average, while the standard deviation describes variation among observations. A standard error by itself does not communicate the full range of participant outcomes. The reported primary standard error is 1.3 in each main group.

How should a mean difference be read?

A mean difference compares the average outcome in one group with the average in the reference group. For the primary outcome, the posted comparisons use CMS-Alone as the reference. A negative difference indicates a lower mean percent change in the named intervention group on the scale used for the outcome. The difference is an unadjusted comparison derived from the posted group summaries, rather than an estimate from a model described in the registry record.

The primary comparisons have intervals and unadjusted p-values. An interval gives a range of values compatible with the estimate under the calculation’s assumptions; it also conveys precision. If an interval includes zero, the data are compatible with no mean difference as well as with differences in either direction. If it excludes zero, that indicates the interval does not include a zero difference under the stated calculation. This is not by itself a statement about clinical importance, and it does not address multiplicity or unreported sources of bias.

What does a p-value say?

In general, a p-value describes how unusual the data, or more extreme data, would be under a statistical model in which the groups have no difference in the outcome. It is not the probability that the null explanation is true, and it does not measure the size or importance of a difference. The posted p-values are unadjusted. They should be interpreted alongside the estimated differences and intervals, rather than as stand-alone evidence.

For the primary endpoint, the unadjusted values are p = 0.003 for CMS-Liraglutide versus CMS-Alone and p = 0.002 for the Multi-Component Intervention versus CMS-Alone. These values are attached to the simple recalculations from posted summary statistics. The registry record does not report the sponsor’s analysis methods, a multiplicity procedure, or other analysis specifications, so these recalculations should not be confused with a fully documented prespecified analysis.

Why does over-dispersion matter?

General statistical context: over-dispersion occurs when observed variability is larger than a statistical model expects. A model that understates variability can produce intervals that are too narrow and p-values that are too small. The posted primary outcome is continuous and summarized with means and standard errors; the registry record does not report a model-based over-dispersion assessment. This concept is most relevant when a model’s distributional assumptions do not adequately represent the observed data. It should not be taken to mean that over-dispersion was found in this trial.

What can be concluded from recalculation?

The comparison calculations are labeled as simple unadjusted recalculations from posted summary statistics, and no discrepancy is flagged in the registry record. They provide a way to examine the magnitude and precision implied by the posted group means and standard errors. They do not reproduce unreported participant-level analyses, adjust for covariates, or account for missing-data procedures. If a discrepancy between a recalculation and a sponsor’s analysis were flagged, the sponsor’s own analysis would take precedence; no discrepancy is flagged for these results.

The registry record lists no reported analyses. That absence does not establish that no analyses were conducted; it means the analysis methods and results are not reported in the registry record. The posted comparison results should therefore be understood as limited, summary-based comparisons, not as evidence about every aspect of the trial’s statistical analysis.

11. Confidence Intervals and Precision

Precision concerns how closely an estimated group difference is determined by the available data and assumptions. The posted comparison intervals give a range around each estimated mean difference. For CMS-Liraglutide versus CMS-Alone, the primary mean difference is -5.4, with an interval from -9.003 to -1.797. For the Multi-Component Intervention versus CMS-Alone, it is -5.7, with an interval from -9.303 to -2.097. Both intervals lie below zero, while still allowing a range of possible magnitudes for the group difference.

The intervals are not so narrow that they identify a single exact difference. They quantify uncertainty around estimates from the posted summaries, not variability among individual participants. The group standard errors are 1.3 for all three primary means. The registry record does not provide primary-outcome standard deviations or participant-level data, so the individual outcome spread cannot be read directly from these standard errors.

The comparison intervals are from simple unadjusted recalculations, and no discrepancy is flagged. They do not reflect an adjustment for multiple outcomes or comparisons. Nor do they account for analysis choices or missing-data handling that are not described in the registry record. The registry record does not state a clinical threshold for an important difference, so statistical precision alone cannot determine whether an estimated difference is clinically important.

The observed means for the two liraglutide groups are similar, but no direct interval for their difference is posted. Without that direct comparison, the precision of any difference between those groups cannot be assessed from the reported comparison results. A lack of a posted direct comparison is not evidence that the interventions are equivalent.

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 describe participants per arm for 80% power and participants per arm for 90% power. They are not total enrollment figures or total event counts. The calculation 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 at the stated fraction of the observed effect. The original trial’s own design assumptions are not reported in the registry record.

In plain language, the 80% power column gives the planning illustration for a design that would have an 80% chance of detecting the specified effect if that effect were the true one and the assumptions held. The 90% power column applies the same idea with a higher target chance of detection, so its participant requirement is generally larger. These planning values are not a description of the number enrolled in the trial and are not evidence that the trial achieved a particular probability of finding a result.

Rows planning for a smaller fraction of the observed effect require more participants per arm, because smaller differences are harder to distinguish from random variation. The figures are based on the observed comparison estimates, so they are illustrative rather than a reconstruction of the original design. They do not incorporate unreported features such as missing observations, covariate adjustment, or multiplicity. This is not observed power.

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 = -5.400; pooled standard deviation σ = 9.192.
2. n = 2 × (1.96 + 0.842)² × 9.192² / -5.400² = 45.5, rounded up to 46 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 <- -5.4                      # observed difference in means
sigma <- 9.19238815542512                     # 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(2911818)
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 = 46 (80% power), 61 (90% power)
 75% of observed effect: n per arm = 81 (80% power), 109 (90% power)
 50% of observed effect: n per arm = 182 (80% power), 244 (90% power)
power.t.test: 46.5 
Simulated power at n = 46 per arm: 0.796 (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 registry record does not report a multiplicity adjustment or a prespecified hierarchy for the primary and secondary comparisons. This matters because the record lists numerous outcomes and includes comparisons of more than one intervention group with the counseling-alone group. If many hypotheses are assessed independently, the chance of at least one apparently unusual result can increase. An adjustment or a clearly specified testing hierarchy can address that concern, but neither is described in the registry record.

The primary endpoint is identified, which distinguishes it from the secondary outcomes, but the record does not provide a statistical analysis plan explaining how the primary and secondary tests were to be interpreted together. The unadjusted p-values for the primary comparisons should not be treated as multiplicity-adjusted results. The same caution applies to secondary comparisons, which are less persuasive as confirmatory findings when their testing context is not stated.

Methods for handling missing outcome measurements are not reported in the registry record. It is therefore not possible to determine from the record whether the posted means use all randomized participants, participants with observed outcomes, or another analysis population. The registry record also does not report how withdrawals, nonadherence, or incomplete follow-up were handled in the primary analysis. These omissions can affect the interpretation of both the estimated group means and their uncertainty.

The analysis population and any intention-to-treat, per-protocol, or other population definitions are not reported in the registry record. The record lists no reported analyses, and it does not describe adjustment for baseline variables or other covariates. These are limits on what can be inferred about the analysis, rather than proof that a particular method was or was not used. The posted summary-based comparisons remain useful descriptions, but a fuller assessment would require the analysis plan, participant flow, missing-data information, and the methods used for the reported results.

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: quadriplegic event (4.5%), asthma exacerbation (2.0%), bile duct stone (2.0%), gastroenteritis (2.0%), pneumonia (2.0%).

The serious adverse-event record gives affected counts and counts at risk separately for the main trial groups and extension groups. In the main groups, the counts affected by serious adverse events were 2 for CMS-Alone, 0 for CMS-Liraglutide, and 3 for the Multi-Component Intervention; each main group has 50 listed at risk. The record lists no deaths in these main groups. These are descriptive counts and should not be read as a comparative safety analysis or as proof that an event cannot occur.

The extension groups are reported separately: the phentermine group has 1 serious adverse event among 22 at risk and 1 death, while the placebo group has 0 serious adverse events among 23 at risk and 0 deaths. These extension observations concern a different study period and should not be combined with the main-trial groups. The extension descriptions indicate that participants continued liraglutide.

The registry record lists serious-event terms and percentages, including Quadriplegic event at 4.5%, and Asthma Exacerbation, Bile duct stone, Gastroenteritis, Pneumonia, and Wound infection at 2.0% each. The record does not provide enough context to attribute these terms to a treatment effect or to compare event risk across groups. Absence of a reported event in a group is not evidence of zero risk.

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

The posted primary results describe lower mean percent change in baseline weight in each liraglutide-containing main group than in CMS-Alone at 52 weeks. The unadjusted recalculated comparisons have intervals that exclude zero. This is a statistical description of group averages under simple calculations from the posted summary statistics, not a guarantee about an individual participant’s outcome.

The results do not establish that every participant lost weight, show the spread of individual changes, or indicate the proportion reaching any particular threshold. The registry summary refers to secondary weight-loss thresholds, but the posted primary outcome is a mean percent change. A group mean cannot answer how many participants reached a threshold unless those counts or proportions are reported.

The comparison of the multi-component intervention with counseling alone cannot isolate which part of the intervention package accounts for the observed group difference. It combines counseling, liraglutide, and a portion-controlled diet. The direct comparison between the two liraglutide groups is not included in the posted comparison results, so their relative effects cannot be established from the means alone.

Statistical evidence from unadjusted comparisons does not by itself establish clinical importance. A clinically meaningful threshold is not reported in the registry record. The results also do not establish durability beyond 52 weeks, effects in populations not described by the trial, or effects on outcomes not reported. The extension study is a separate phase with distinct groups and does not extend the main-trial comparison automatically.

The registry record does not report the original sample-size justification, analysis populations, missing-data methods, or multiplicity plan. These omissions leave uncertainty about how the posted summaries relate to the trial’s original analysis strategy. The findings should therefore be read as reported group estimates with their stated uncertainty, not as medical advice or a complete basis for decisions about care.

17. Why This Trial Matters Statistically

This trial illustrates why a clear primary endpoint matters when a study includes multiple intervention components and many secondary measurements. Percent change in baseline weight gives a defined group-level outcome over the stated follow-up. The three main groups allow the posted results to compare counseling alone with two approaches that include liraglutide, while the diet-containing group represents a package rather than an isolated test of diet.

It also shows why effect estimates and intervals are more informative than p-values alone. The mean differences describe the direction and magnitude of the primary comparisons, while the intervals convey uncertainty. The unadjusted p-values add information about compatibility with a no-difference model, but do not measure clinical importance or resolve multiplicity concerns.

The record highlights a common reporting challenge: a registry may identify an outcome and post group summaries without reporting enough analysis detail to reconstruct the original statistical plan. Missing information about analysis populations, incomplete observations, multiplicity, and the original design assumptions limits how fully readers can assess the results. Stating those limits helps distinguish what the numerical estimates show from what cannot be concluded.

The secondary outcomes further demonstrate that a trial can measure multiple dimensions of health without establishing a unified pattern across them. Their interpretation depends on complete estimates, uncertainty, and a clear account of how multiple comparisons were handled. The safety record also requires attention to separate study periods and groups rather than treating every listed group as part of one direct comparison.

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 registry record describes the main trial as open-label, so participants and study personnel were not masked according to that description. The record does not explain whether outcome measurement or analysis had any separate masking. The single-center setting also limits how confidently the results can be generalized to other settings, and the registry record does not describe broader recruitment or representativeness.

The primary results are posted as group means and standard errors. The record does not provide participant-level data, primary-outcome standard deviations, or the full distribution of outcomes. A mean does not reveal whether results were consistent across participants, and the standard error should not be mistaken for individual variability. The direct comparison between the two liraglutide groups is not reported among the posted primary comparisons.

The original sample-size justification and design assumptions are not reported in the registry record. Nor are the analysis populations, missing-data approach, adherence summaries, or multiplicity methods. Consequently, the simple unadjusted recalculations cannot replace a full analysis using the original participant-level data and planned methods.

The trial summary describes participants free of type 1 and type 2 diabetes and contraindications to weight loss, which defines limits on the population described. It does not provide further detail about participant characteristics in the posted results. Follow-up for the main outcome is 52 weeks; outcomes after that period are not reported as part of the main comparison. The extension groups concern a separate study period and should not be treated as additional main-trial arms.

Finally, the registry summary is truncated in its description of secondary weight-loss thresholds, and detailed results for the full set of 32 secondary outcomes are not reported in the record included in the posted results. These reporting limits make it difficult to assess the complete outcome picture.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Lifestyle Modification and Liraglutide — NCT02911818.
• Registry record last updated 2019-05-07; status last verified 2019-04.
• Results first posted 2019-05-07.
• 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

NCT02911818, titled Lifestyle Modification and Liraglutide, is listed as a completed Phase 4 randomized, parallel-group, open-label, single-center trial. The official title is Combining Lifestyle Modification and Liraglutide to Improve Weight Loss and Health Outcomes. The registry record lists enrollment of 150, with start in 2016-09 and primary completion in 2018-11.

The main comparison involved CMS-recommended lifestyle counseling alone, counseling plus liraglutide, and counseling plus liraglutide with a portion-controlled diet. The primary outcome was mean percent change in baseline weight from randomization to 52 weeks. Posted group means were -6.1, -11.5, and -11.8, respectively. Simple unadjusted recalculations comparing each liraglutide-containing group with counseling alone yielded mean differences of -5.4 and -5.7, with intervals excluding zero.

The registry record lists 32 secondary outcomes and separate extension-study groups. Original design assumptions, analysis populations, missing-data methods, and multiplicity procedures are not reported in the registry record.