Lifestyle Modification and Lorcaserin for Weight Loss Maintenance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Lifestyle Modification and Lorcaserin for Weight Loss Maintenance (NCT02388568), a randomized na study. The primary outcome is Change in Weight (kg).

2. Clinical Question

The clinical question is about maintaining weight loss after an initial dietary period, rather than comparing the full dietary run-in as part of the primary endpoint. The randomized groups received the same general lifestyle-modification component, so the contrast focuses on lorcaserin versus placebo within that context. The registry does not report a separate primary analysis population beyond the participants and group results listed for the outcome.

3. Trial Design

The registry describes a completed, randomized, parallel-group trial with quadruple masking. The registered title is “Lifestyle Modification and Lorcaserin for Weight Loss Maintenance.” The listed phase is NA, and the sponsor is the University of Pennsylvania. The record gives a start date of 2015-01 and a primary completion date of 2017-06.

The study was designed around a 14-week dietary run-in followed by a randomized period. During the run-in, participants attended weekly group lifestyle counseling and followed a portion-controlled diet described as 1000-1200 kcal/day, with liquid diet servings and an evening frozen-food entree, fruit, and vegetable serving. To qualify for randomization, participants had to lose at least 5% of initial weight during this period. The registry summary says the proposed randomized trial would assess lifestyle counseling combined with lorcaserin or placebo for 12 months.

The brief summary says 182 women and men would be enrolled in the run-in and anticipates that 136 would qualify for randomization. These are planning statements in the summary, not the randomized outcome counts. For the primary outcome, the registry lists 69 participants in the lorcaserin-plus-lifestyle group and 68 in the placebo-plus-lifestyle group. The record does not explain the relationship between the anticipated randomization count and the posted outcome counts.

The primary outcome timeframe is 52 weeks post-randomization. The primary endpoint is change in weight from randomization to week 52, explicitly excluding weight loss during the run-in. The registry lists six outcome measures and four secondary outcomes, with no reported analyses attached to the secondary outcomes. Details such as the original statistical analysis plan, allocation concealment procedures, which roles were masked, and the handling of deviations from assigned treatment are not reported in the registry record.

4. Participant Flow and Accounting

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Weight (kg), measured over 52 weeks post-randomization.

The primary endpoint is change in weight, measured in kilograms, from randomization to week 52. The registry specifies that this change does not include the weight loss in the 14-week low-calorie-diet run-in. The posted group summaries are means, with standard errors as the measure of dispersion.

A mean change is useful for describing the average weight trajectory in each randomized group over the specified period. Comparing the group means focuses the randomized contrast on what happened after randomization, rather than mixing in the initial dietary phase that participants completed before assignment. The primary comparison is expressed as the lorcaserin-plus-lifestyle group mean minus the placebo-plus-lifestyle group mean.

The posted mean changes are 2.0 kg for lorcaserin plus lifestyle modification and 2.5 kg for placebo plus lifestyle modification. The unadjusted recalculated difference is -0.5 kg, with a 95% confidence interval from -2.717 to 1.717. The interval describes uncertainty around the group contrast; it is not a range containing every individual participant’s change. The registry does not report a separate adjusted primary analysis or identify a distinct analysis population for this endpoint.

7. Results Posted in the Registry

• Lorcaserin Plus Lifestyle Modification: mean 2.00 versus 2.50 on control; difference -0.50 (95% CI -2.72 to 1.72), standardized effect d = -0.08; z-test p = 0.659.

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.

Body Weight (% Change)

• 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:
  • Lorcaserin Plus Lifestyle Modification: mean 1.80 versus 2.20 on control; difference -0.40 (95% CI -2.62 to 1.82), standardized effect d = -0.06; z-test p = 0.724.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lorcaserin Plus Lifestyle Modification and the control. The interval gives the range of effects that remain compatible with the data.

Proportion Maintaining >= 10% Loss of Initial Weight

• 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:
  • Lorcaserin Plus Lifestyle Modification: 29.0% (20/69) versus 29.4% (20/68) on control; risk difference -0.4 percentage points (95% CI -15.7 to 14.8), risk ratio 0.99 (0.59–1.66); unadjusted two-proportion z-test p = 0.956.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lorcaserin Plus Lifestyle Modification and the control. The interval gives the range of effects that remain compatible with the data.

Body Weight

• 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:
  • Lorcaserin Plus Lifestyle Modification: mean -9.40 versus -7.50 on control; difference -1.90 (95% CI -4.54 to 0.74), standardized effect d = -0.24; z-test p = 0.158.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lorcaserin Plus Lifestyle Modification and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes provide several views of weight after randomization and across the longer period beginning at the start of the dietary program. Across these measures, the posted summaries do not present a consistent pattern of a clear between-group separation. The secondary weight-change estimate after randomization is close in direction and scale to the primary contrast, while the binary outcome of maintaining at least 10% loss has equal posted counts in the two groups. The longer-period weight measure uses a different starting point and therefore includes the run-in period, unlike the primary endpoint.

These outcomes help place the primary result in context, but they answer related rather than identical questions. A continuous mean summarizes average change; a binary measure classifies participants according to a threshold; and a measure beginning at the start of the low-calorie-diet program includes a period before randomization. Differences in outcome definition and time origin mean that results should not be treated as repetitions of the same endpoint.

In general, secondary outcomes are useful for examining whether the primary pattern is echoed across other measures and for identifying questions for further study. They usually carry less evidential weight than a prespecified primary outcome when there are multiple outcomes and no reported multiplicity strategy. Repeated testing can increase the chance of observing an apparently notable result even if there is no corresponding underlying effect. The registry does not report a testing hierarchy, multiplicity adjustment, or analysis plan for the secondary outcomes.

The registry lists four secondary outcomes, but the number of analyses reported for them is zero. The available group summaries and unadjusted recalculations therefore do not document a set of sponsor-reported, adjusted secondary analyses. These secondary results are best read as descriptive context alongside the primary estimate, not as independent confirmation or as a basis for choosing whichever outcome appears most favorable.

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

• Body Weight (% Change)
• Proportion Maintaining >= 10% Loss of Initial Weight
• Body Weight
• Body Weight (% Change)

9. Statistical Interpretation

10. Statistical Methods Explained

The posted continuous outcomes are summarized using group means and standard errors. The mean is the arithmetic average of the measured values within a group. A standard error describes the precision of an estimated mean, rather than the spread of individual participant measurements. The registry does not also provide standard deviations for the primary outcome.

What does the group contrast represent?

The primary contrast is a difference in means: the lorcaserin-plus-lifestyle mean minus the placebo-plus-lifestyle mean. A negative estimate means the reported mean in the lorcaserin group is lower than the reported mean in the placebo group on the outcome’s signed scale. The estimate is -0.5 kg. This direction describes the group contrast; it does not by itself establish a meaningful or reliable difference.

The comparison estimates and p-values are unadjusted recalculations from the posted summary statistics. They do not represent a reported covariate-adjusted model. The registry lists no reported analyses for the primary outcome. The statistical analysis plan, including any preferred model or adjustment variables, is not reported in the registry record.

How should the p-value be read?

In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the calculation assumptions were correct. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or a measure of the size or clinical importance of an effect. The primary unadjusted p-value is 0.659. Its interpretation belongs alongside the estimated difference and confidence interval, not in place of them.

In general, a conventional significance threshold is a decision rule rather than a dividing line between a real and unreal effect. The registry record does not report the trial’s prespecified threshold, testing hierarchy, or multiplicity procedure. The planning illustration separately specifies a two-sided significance level of 0.05; that assumption is for the illustrative sample-size calculations and should not be mistaken for a reported trial analysis plan.

What does the confidence interval add?

In general, a confidence interval represents the uncertainty in an estimate under the statistical procedure used. Narrower intervals indicate greater precision, while wider intervals indicate less precision. The primary 95% interval extends from -2.717 to 1.717 kg. Because it includes zero and spans values on both sides of zero, it does not pin down the direction of the underlying contrast. The interval also does not say that a fixed proportion of individual changes lies inside it.

The interval is based on an unadjusted calculation from the posted group summaries. It may not match an estimate from a different analysis model or population. Neither a sponsor-reported inferential analysis nor an adjusted confidence interval is listed in the registry record, so no such comparison can be made from the record.

What is the role of the run-in?

The run-in selected people for randomization based on a weight-loss criterion. This means the randomized findings address the post-randomization contrast among those who qualified, not the effect of assigning treatment at the start of the dietary program among all people entering it. The primary endpoint begins at randomization, whereas one secondary measure covers the period from the start of the low-calorie-diet program to week 52. These outcomes answer different questions because their time origins differ.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variation is greater than a statistical model expects. If a model does not allow enough variation, standard errors can be too small and confidence intervals too narrow. This concern is relevant to some count or binary analyses, but the registry does not report a fitted model for the secondary proportion outcome. The primary outcome is continuous and is summarized with means and standard errors; the record does not describe a model-based over-dispersion assessment.

The record does not report how missing measurements were handled, whether all randomized participants were included in each analysis, or whether the primary analysis followed an intention-to-treat principle. It also does not report interim analyses, stopping rules, or a formal sample-size justification for the original trial. These details cannot be inferred from the posted summary statistics.

11. Confidence Intervals and Precision

The primary mean difference is -0.5 kg, with a 95% confidence interval from -2.717 to 1.717. The interval is wide enough to include values below and above zero, so the estimate does not precisely determine the direction of the group contrast. It conveys more information than the point estimate alone by displaying the uncertainty compatible with the unadjusted calculation.

In general, a confidence interval is an estimate plus a margin reflecting sampling uncertainty under a particular method and its assumptions. It is not a prediction interval for individual participants, and it does not account automatically for every possible source of bias or uncertainty. Here, the interval is calculated from the posted summary statistics. The registry does not report an adjusted interval, the model underlying a sponsor analysis, or a prespecified interval method.

The standard error is 0.8 kg in each primary-outcome group. A standard error reflects the precision of a group mean, whereas individual values can vary more widely. The registry does not provide individual-level outcomes or standard deviations for this endpoint, so the spread of participant-level weight changes cannot be recovered from the reported standard errors alone without additional assumptions.

The unadjusted p-value is 0.659. It does not remove the uncertainty evident in the confidence interval, and it should not be interpreted as evidence that the two groups are identical. The interval is also not a test of equivalence or non-inferiority, since the registry does not report an equivalence margin or non-inferiority framework. The appropriate reading is that the point estimate is modest in relation to its uncertainty, and that the posted summary does not tightly specify the direction or size of the underlying contrast.

12. Planning a Similar Trial: Sample Size

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

The planning figures are illustrations based on the observed effect, not the original trial’s design assumptions. For the continuous outcomes and the binary outcome in this record, the figures are participants per arm, not total events. 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 to the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm associated with an 80% chance of detecting the specified effect under those assumptions, if the assumed effect and calculation model were correct. The 90% power column uses a higher target chance of detection and therefore generally calls for more participants per arm. These are planning quantities, not counts observed in the trial.

Rows describing planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect make clear how the assumed target changes the calculation. A smaller effect is harder to distinguish from random variation, so the illustration requires more participants per arm for the smaller-effect scenarios. The required numbers also depend on the outcome type and the estimated effect used in the calculation; the very different figures across outcomes should not be treated as interchangeable.

The corresponding curve represents how the planning requirement changes as the assumed effect changes. It is a planning aid, not a reconstruction of the trial’s actual power. This is not observed power: it does not describe the probability that the completed trial detected an effect, nor does it alter the uncertainty in the posted estimates. The registry record does not report the original trial’s design calculation, and these illustrations should not be read as evidence about why the trial enrolled its observed participants.

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 = -0.500; pooled standard deviation σ = 6.621.
2. n = 2 × (1.96 + 0.842)² × 6.621² / -0.500² = 2,752.9, rounded up to 2,753 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 <- -0.5                      # observed difference in means
sigma <- 6.62135713961801                     # 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(2388568)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2,753 (80% power), 3,686 (90% power)
 75% of observed effect: n per arm = 4,895 (80% power), 6,552 (90% power)
 50% of observed effect: n per arm = 11,012 (80% power), 14,742 (90% power)
power.t.test: 2753.9 
Simulated power at n = 2,753 per arm: 0.798 (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

Multiplicity arises when several outcomes, comparisons, time points, or analysis choices are tested. In general, as the number of tests increases, the chance of at least one apparently unusual result can rise. Statistical plans commonly address this by defining a primary endpoint, specifying a testing order, or adjusting inference across a family of tests. The registry identifies a primary outcome and lists secondary outcomes, but a multiplicity plan is not reported in the registry record.

The record does not report a prespecified hierarchy for the secondary outcomes, an adjustment method, or whether any outcomes were exploratory. The posted unadjusted p-values should therefore be interpreted as individual, unadjusted comparisons, not as results protected against multiple testing. This limitation matters most when comparing or emphasizing several outcomes together. It does not change the numerical estimates, but it affects how confidently they can be treated as confirmatory evidence.

Missing-data methods are also not reported in the registry record. The outcome summaries list group sizes, but they do not establish whether every randomized participant contributed a measurement, how missing values were handled, or whether analyses used imputation, a model-based method, or complete cases. The analysis population is not specified as intention-to-treat, per-protocol, or another defined population. The registry record does not report reasons for missing outcome data or sensitivity analyses assessing the effect of missingness.

The registered masking designation is quadruple, but the record does not identify which participants, clinicians, assessors, or other roles were masked. It also does not report procedures for allocation concealment or deviations from assigned treatment. Interim analyses, stopping rules, and the trial’s original statistical analysis plan are not reported. These omissions mean that the posted results cannot establish how prespecified choices were protected from being influenced by emerging data, or how robust the findings are to alternative analysis decisions.

These are reporting limitations, not proof that particular procedures were absent. Without the relevant details in the registry record, readers cannot assess the impact of missingness, multiplicity, or analysis-population choices on the estimates.

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 3% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia (2.9%), asthma exacerbation (1.5%), cholelithiasis (1.5%), hypertension (1.5%), lung nodules (1.5%).

The registry records serious adverse events in 2 of 69 participants in the lorcaserin-plus-lifestyle group and 8 of 68 participants in the placebo-plus-lifestyle group. It records other adverse events in 56 of 69 and 49 of 68 participants, respectively. No deaths are recorded in either group. These are posted counts, not adjusted comparisons, and they should be read with the group sizes and the limits of the registry’s safety reporting.

The record lists pneumonia at 2.9%, and asthma exacerbation, cholelithiasis, hypertension, lung nodules, and pregnancy at 1.5% each, among the most frequent serious adverse event terms. It does not assign those listed percentages to a particular randomized group in the provided event-term summary, so they should not be attributed to one group without further information.

In general, adverse-event counts describe events recorded under the trial’s reporting procedures; they do not establish that a treatment caused an event. The registry does not report definitions, severity grading beyond the serious-event classification, exposure-adjusted rates, or a statistical comparison of safety outcomes. The figures alone do not establish the overall safety profile or permit conclusions about uncommon events.

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

The primary result describes a randomized comparison of lorcaserin plus lifestyle modification versus placebo plus lifestyle modification among participants who qualified after the dietary run-in. The reported mean changes from randomization to week 52 were 2.0 kg and 2.5 kg, and the unadjusted recalculated between-group difference was -0.5 kg. Its 95% confidence interval, from -2.717 to 1.717, includes zero and leaves uncertainty about both the direction and size of the contrast.

This result does not establish that the groups were equivalent, nor does it show that any possible difference is absent. Equivalence requires a prespecified margin and an analysis designed to assess whether the interval falls within that margin; neither is reported in the registry record. The estimate also does not by itself determine whether a difference is clinically important, since the registry does not report a threshold for meaningful change.

The result concerns weight change after randomization. It does not include the weight loss during the 14-week run-in, and it does not describe outcomes among participants who entered the run-in but did not qualify for randomization. The study’s selection process makes the randomized question narrower than the question of what would happen if all people starting the dietary program were assigned to one of the study treatments.

The secondary outcomes add descriptive context, but their different definitions and time origins matter. The posted results do not include reported secondary analyses, adjustment for multiple testing, or analysis details that would support treating those outcomes as confirmatory. Safety counts likewise describe recorded events and should not be used alone to infer causation or comparative safety.

More broadly, the registry results are not a complete account of every feature needed to evaluate the trial. Missing-data methods, the analysis population, the original sample-size justification, and the statistical analysis plan are not reported in the registry record. The posted summaries therefore support a careful description of the observed group estimates and their uncertainty, but they do not resolve all questions about robustness, generalizability, or the effects of analysis choices.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison needs to be read together with the population, time origin, and endpoint definition. Participants were selected for randomization after meeting a weight-loss threshold in a dietary run-in. The primary endpoint then began at randomization and excluded that run-in. A reader who treats the result as a comparison of total change from the start of the program would be answering a different question from the one defined by the primary endpoint.

The results also show the value of reporting an estimate with a confidence interval. The primary point estimate is -0.5 kg, but its interval runs from -2.717 to 1.717. The point estimate alone might seem to give a simple answer about the direction of the contrast; the interval makes clear that considerable uncertainty remains around it. A p-value alone would not convey the range of differences compatible with the data and calculation.

Another statistical lesson is that outcome types are not interchangeable. A mean change describes the group average, a threshold outcome counts participants meeting a defined criterion, and a measure spanning the run-in and randomized period uses a different time origin. Similarity or difference across those outcomes needs interpretation in light of what each measures.

Finally, the registry makes visible limits in the available analysis record. There are no reported analyses listed for the outcomes, and details of missing-data handling, multiplicity, and the original sample-size rationale are not reported. Recognizing these gaps is part of sound interpretation: readers can distinguish the descriptive information that is available from inferential or design details that the record does not establish.

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 randomized findings apply to participants who met the run-in qualification criterion, not automatically to everyone with obesity or everyone who began the dietary program. The registry summary requires at least 5% initial weight loss over the 14-week run-in for randomization. Results for participants who did not qualify are not reported in the registry record, so the randomized comparison does not describe their subsequent outcomes.

The primary endpoint begins at randomization and excludes the run-in. The separate secondary measure covering the period from the start of the low-calorie-diet program through week 52 has a broader time window. These definitions should not be conflated when interpreting weight change. The registry does not report how long participants followed each intervention in practice or adherence to the assigned treatment.

The primary outcome results are group summaries with standard errors. Individual participant data, standard deviations, and detailed outcome distributions are not reported in the registry record. Missing-data handling, the analysis population, covariate adjustment, and sensitivity analyses are also not reported. This limits assessment of how the estimates might change under alternative assumptions or analysis choices.

The comparison estimates are unadjusted recalculations from summary statistics, and no reported analyses are listed. The registry does not report an original statistical analysis plan, a multiplicity strategy, or the trial’s own sample-size justification. The planning figures are illustrative calculations based on observed effects and should not be treated as evidence that the original trial was designed around those assumptions.

For safety, the record gives counts and selected serious-event terms but does not report a statistical safety comparison, exposure-adjusted rates, or detailed event definitions. The registry also does not report which roles were covered by quadruple masking. These limits constrain interpretation of both efficacy estimates and safety summaries without implying that unreported procedures were necessarily absent.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Lifestyle Modification and Lorcaserin for Weight Loss Maintenance — NCT02388568.
• Registry record last updated 2018-06-11; status last verified 2018-05.
• Results first posted 2018-06-11.
• 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

NCT02388568 is a completed randomized, parallel-group trial titled “Lifestyle Modification and Lorcaserin for Weight Loss Maintenance,” sponsored by the University of Pennsylvania. The registry lists quadruple masking and a phase of NA. The record gives a start date of 2015-01 and a primary completion date of 2017-06.

The primary endpoint is change in weight from randomization to week 52, excluding the 14-week dietary run-in. The posted means are 2.0 kg for lorcaserin plus lifestyle modification and 2.5 kg for placebo plus lifestyle modification. The unadjusted recalculated difference is -0.5 kg, with a 95% confidence interval from -2.717 to 1.717 and an unadjusted p-value of 0.659.

The registry also lists secondary weight outcomes and adverse-event summaries. No analyses are listed for the secondary outcomes. Details of the original statistical plan, missing-data handling, analysis populations, and multiplicity procedures are not reported in the registry record.