This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (NCT03611582), a randomized phase 3 study. The primary outcome is Change in Body Weight (%).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03611582 |
| Phase | Phase 3 |
| Condition | Overweight, Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 611 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novo Nordisk A/S |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned people with overweight or obesity. The registry lists an enrollment of 611 and says the primary analysis population was the full analysis set, comprising all randomized participants; the number analyzed for the endpoint depended on who had available data. The registry record does not provide further eligibility details in the information recorded for this analysis.
Intervention
Participants assigned to the active-treatment arm received semaglutide 2.4 mg once weekly during a 68-week treatment period, alongside intensive behavioural therapy. The study description also refers to a low-calorie diet during the first 2 months and support focused on food choices, weight loss, and physical activity.
Comparator
The comparison arm received placebo once weekly alongside the same intensive behavioural therapy. Treatment assignment was randomized, so allocation was determined by chance rather than participant or clinician choice. The registry describes the study as quadruple-masked but does not identify all roles covered by that masking label in the record.
Primary question
The primary endpoint was mean percentage change in body weight from baseline at week 0 to week 68. The clinical question is whether the recorded average change differed between the semaglutide and placebo groups when both were used with the behavioural program. The registry record does not report the group means, the between-group estimate, its uncertainty, or a test result, so the size and precision of any difference cannot be assessed from this record.
3. Trial Design
This was a randomized, parallel-group, phase 3 study of semaglutide 2.4 mg and placebo, each given alongside intensive behavioural therapy. The registry lists an enrollment of 611. That is the recorded enrollment, not necessarily the number with endpoint data: the primary outcome description states that the analyzed number was the number of participants with available data. The analysis population was defined as the full analysis set, comprising all randomized participants, while outcome summaries could include fewer participants if data were unavailable.
The study is listed as quadruple-masked. Masking is intended to reduce the influence of treatment knowledge on participant experiences, care, assessment, or analysis, depending on which roles are masked. The registry record does not specify those roles. The parallel design means participants were assigned to an arm and followed under that assignment rather than crossing between treatments. The record identifies allocation as randomized but does not report the randomization procedure or any stratification factors.
The active arm received semaglutide 2.4 mg over a 68-week treatment period; the comparator arm received semaglutide placebo over the same period. Both arms included intensive behavioural therapy. The brief description also mentions a low-calorie diet for the first 2 months, weekly injections, and 32 clinic visits. These elements are part of the study context, so the comparison is between treatment strategies used with behavioural support, not between medication and no accompanying program.
The registry lists the study as completed, with a start date of 2018-08-01 and primary completion date of 2020-03-18. These dates describe the study record and do not supply the missing numerical primary-endpoint results. The registry record does not report the detailed statistical analysis plan, sample-size justification, interim analyses, or allocation concealment procedure.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: The trial has a 68-week treatment period (16 weeks of dose escalation and 52 weeks of maintenance dose). Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo.
Overall Study
| Stage | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| STARTED | 407 | 204 |
| Full Analysis Set (FAS) | 407 | 204 |
| Safety Analysis Set (SAS) | 407 | 204 |
| COMPLETED | 339 | 166 |
| NOT COMPLETED | 68 | 38 |
Reasons for not completing this period:
| Reason | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Adverse Event | 26 | 6 |
| Protocol Violation | 0 | 1 |
| Pregnancy | 1 | 2 |
| Lack of Efficacy | 0 | 1 |
| At the discretion of the investigator | 1 | 0 |
| Safety concern as judged by the investigator | 1 | 2 |
| Withdrawal by Subject | 4 | 3 |
| Lost to Follow-up | 18 | 7 |
| other | 17 | 16 |
Analysis population for the primary outcome, as defined in the registry: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
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: Full analysis set (FAS) included all randomised participants.
| Characteristic | Unit | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 407 | 204 | 611 | |
| Age, Continuous | Years | 46 (SD 13) | 46 (SD 13) | 46 (SD 13) |
| Sex: Female, Male: Female | Participants | 315 | 180 | 495 |
| Sex: Female, Male: Male | Participants | 92 | 24 | 116 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 75 | 46 | 121 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 332 | 158 | 490 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 5 | 6 | 11 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 80 | 36 | 116 |
| Race (NIH/OMB): White | Participants | 307 | 158 | 465 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 11 | 4 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Body Weight (%), measured over Baseline (week 0) to week 68.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean percentage change in body weight from baseline, defined as week 0, to week 68. It summarizes change relative to each participant’s baseline body weight and then describes the average change within an analysis group. The registry identifies the endpoint as a mean and lists standard deviation as its dispersion measure. However, no arm-level mean, standard deviation, participant count with available data, or between-arm estimate is reported in the registry record.
General: A continuous endpoint such as percentage change retains information about the magnitude of change, rather than reducing each participant’s result to a category such as reached or did not reach a threshold. A group mean provides a compact description of the average outcome, while the standard deviation describes how dispersed participant outcomes are around that mean. The standard deviation is not the same as the uncertainty around the mean or around a treatment contrast; those require suitable inferential summaries, such as confidence intervals.
Weight change is used to compare the average body-weight trajectory under the assigned study strategies. Percentage change expresses change in relation to baseline body weight, which can aid interpretation across people with different starting weights. The direction and clinical interpretation of a reported value depend on the endpoint’s sign convention and the study context. The registry record does not give a numerical estimate or state a sign convention for the posted result, so neither the amount nor precision of the observed group difference can be described.
The endpoint description says that evaluation used data from both in-trial and on-treatment periods. The in-trial observation period ran from randomization at week 0 to the last trial-related site contact at week 75. The on-treatment period covered intervals when participants were considered on treatment from week 0 through the last product administration at week 68, including 2 weeks of follow-up, and excluded temporary interruptions defined as more than 2 consecutive missed doses. These definitions clarify which observations could contribute to the endpoint, but do not by themselves reveal how missing measurements were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the intended primary comparison clearly: average percentage change in body weight from week 0 to week 68 for semaglutide 2.4 mg plus intensive behavioural therapy versus placebo plus the same program. It does not report the numerical endpoint results. In particular, the record has no group means, standard deviations, treatment contrast, confidence interval, or p-value for the primary endpoint. The direction, magnitude, and precision of the observed comparison therefore cannot be stated from this information.
This absence matters for interpretation. Knowing the endpoint definition and the trial design is not enough to infer what the trial found. The study’s randomized design supports a structured comparison of assigned strategies, but randomization alone does not provide the outcome estimate. Nor can the primary result be reconstructed from the enrollment figure, the safety counts, or the list of secondary outcomes. Those are different quantities and do not substitute for the primary endpoint analysis.
General: A between-group estimate describes the observed contrast between treatment strategies. A confidence interval describes the range of values reasonably compatible with the data and the analysis assumptions; it conveys precision as well as direction. A p-value, when reported, addresses compatibility with a specified null model, not the size or importance of an effect. These statistics answer related but distinct questions. None is reported for the primary endpoint in the registry record.
The registry describes the primary endpoint as evaluated using both in-trial and on-treatment observations. Those periods address different ways of defining observation after randomization. An in-trial approach follows the defined trial observation window, including after treatment stops, whereas an on-treatment approach focuses on intervals considered on treatment and excludes specified interruptions. The record states these definitions, but does not report how the primary comparison incorporated observations from these periods or what assumptions were used when measurements were missing.
The safety record lists serious adverse events in both arms, other adverse events, and zero deaths in each group. These figures are descriptive counts; no comparative safety estimate, confidence interval, or test is reported. They should not be interpreted as establishing that the strategies have equal or different safety profiles. The serious-event terms and percentages are also descriptions of reported events, not estimates of the primary weight endpoint.
Other outcomes listed include weight-loss thresholds, waist circumference, systolic blood pressure, physical functioning, body weight in kilograms, and body mass index. Their presence indicates additional measured outcomes, but the registry record does not give their numerical results in the material. No claim about their direction, size, or statistical significance follows from their names alone. Overall, the record supports a description of the question, design, endpoint definitions, and selected safety counts, but not a conclusion about the numerical primary treatment contrast.
9. Statistical Methods Explained
What does the mean summarize?
The primary outcome is a continuous measure: percentage change in body weight between baseline and week 68. The registry identifies the summary statistic as a mean. A mean combines participant-level values into an average for the analysis group. It can be useful for describing the central tendency of a continuous outcome, but it does not show whether individual results were tightly clustered or widely spread. The listed standard deviation provides a description of that spread. Neither group means nor standard deviations are numerically reported in the registry record.
General: A treatment comparison is usually expressed as a contrast between group summaries, with uncertainty around that contrast. The estimate describes the observed difference under the chosen analysis; its uncertainty reflects sampling variation and depends on the analysis assumptions. A confidence interval is useful because it shows a range of effect values compatible with the observed data and method. It is not a guarantee that the true effect lies within the interval. No numerical interval or between-group estimate is reported for this primary outcome in this record.
What do randomization and masking contribute?
Random allocation is intended to make assigned groups comparable, on average, with respect to both measured and unmeasured characteristics at entry. It does not guarantee identical groups, and it does not remove uncertainty from the resulting estimates. A parallel-group design compares groups followed under their assigned treatment strategies. Quadruple masking indicates that the registry classifies the study as masked across multiple roles, but the roles are not specified in the record. In general, masking can limit the influence of treatment knowledge on reporting, care, measurement, or analysis, depending on who is masked.
The registry does not state the sequence-generation method, allocation concealment details, stratification factors, or the statistical model used for the primary comparison. These details can affect how an analysis is implemented and interpreted. They should not be inferred from the labels randomized, parallel, or quadruple-masked.
Why distinguish in-trial from on-treatment observation?
The endpoint description defines an in-trial observation period from randomization at week 0 to the last trial-related site contact at week 75. It separately defines an on-treatment observation period as intervals when participants were considered on treatment, from week 0 through last product administration at week 68, including 2 weeks of follow-up. Temporary interruptions were excluded from the on-treatment period when they involved more than 2 consecutive missed doses.
General: These observation strategies can answer different questions. An in-trial strategy can retain follow-up after treatment discontinuation, while an on-treatment strategy focuses on measurements during defined treatment exposure. The choice affects which observations are relevant and can affect the interpretation of the estimate. The registry supplies the period definitions, but does not report enough detail to determine the exact estimand, the handling of treatment discontinuation in the primary analysis, or how data from the two periods were combined.
How should dispersion and over-dispersion be understood?
The primary endpoint is continuous and its listed dispersion measure is standard deviation. Standard deviation describes participant-level variability around a group mean. It is not a measure of how precisely the mean is estimated. Precision also depends on the amount of usable information and the analysis approach. The registry record does not report the endpoint standard deviations or the number analyzed in each arm.
General: Over-dispersion is most often discussed for count outcomes, when observed variability exceeds what a simple model assumes. In such settings, ignoring extra variability can make uncertainty appear too small. It is not a substitute term for the standard deviation of a continuous outcome, and the record does not indicate that an over-dispersion adjustment was used for this primary endpoint. No statistical model or variance adjustment is reported.
What can be said about significance and planning?
The record does not report a primary-endpoint p-value or confidence interval. Therefore, statistical significance cannot be assessed from these entries, and statistical significance should not be confused with clinical importance. General: A p-value is conditional on a model and a null hypothesis; it does not measure the probability that a treatment works, nor does it state the probability that the result occurred by chance in a general sense. Effect size and its uncertainty are needed for a fuller interpretation.
The registry describes sample-size planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect; for time-to-event outcomes, the illustration would count total events, while other outcomes would use participants per arm. No numerical planning estimates are present in the record. Such illustrations, when available, are planning calculations, not observed power and not proof that a study was adequately powered. The registry does not report the trial’s own sample-size justification or detailed statistical plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes, including weight-loss thresholds of at least 10%, at least 15%, and at least 20%, as well as waist circumference, systolic blood pressure, physical functioning, body weight in kilograms, and body mass index. It also records 31 outcome measures and 4 analyses. These entries indicate a broad set of outcomes and analyses, but do not explain which comparisons were confirmatory, how outcome families were defined, or whether any multiplicity adjustment was planned or applied. The multiplicity strategy is not reported in the registry record.
General: When many outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if each is treated as an independent opportunity for a positive finding. Prespecified hierarchies, adjusted testing procedures, or a clear distinction between confirmatory and exploratory results can help readers understand the strength of evidence. The number of listed outcomes alone does not establish how multiplicity was handled. No adjustment method or testing hierarchy should be inferred from the registry entries.
The primary population is described as the full analysis set, comprising all randomized participants, while the number analyzed is defined as participants with available data. The endpoint description distinguishes in-trial from on-treatment periods and defines temporary treatment interruption. However, the record does not state the missing-data method, imputation approach, assumptions about missingness, sensitivity analyses, or how discontinuation and interruptions were handled in the primary estimand. These details are not reported in the registry record.
General: Missing outcomes can affect both the amount of information available and the interpretation of a treatment comparison. Analyses may rely on assumptions about why measurements are missing and how unobserved outcomes relate to observed information. Sensitivity analyses can assess whether conclusions change under alternative assumptions. Without the analysis specification and missingness summaries, readers cannot assess these issues for the primary endpoint. The record also does not report the number with available primary-outcome data by arm, so the endpoint analysis population cannot be quantified from this information.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Semaglutide 2.4 mg | 37 | 407 | 9.1% |
| Placebo | 6 | 204 | 2.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Semaglutide 2.4 mg | 0 of 407 |
| Placebo | 0 of 204 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Semaglutide 2.4 mg | 379 of 407 |
| Placebo | 177 of 204 |
Most frequent serious adverse event terms
| Event term | Organ system | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | 7 of 407 | 0 of 204 |
| Appendicitis | Infections and infestations | 3 of 407 | 0 of 204 |
| Cholecystitis acute | Hepatobiliary disorders | 3 of 407 | 0 of 204 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 3 of 407 | 0 of 204 |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | 2 of 407 | 0 of 204 |
| Cholecystitis | Hepatobiliary disorders | 2 of 407 | 0 of 204 |
| Abdominal abscess | Infections and infestations | 1 of 407 | 0 of 204 |
| Abdominal pain | Gastrointestinal disorders | 1 of 407 | 0 of 204 |
| Anxiety | Psychiatric disorders | 1 of 407 | 0 of 204 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 407 | 0 of 204 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 237 of 407 | 45 of 204 |
| Constipation | Gastrointestinal disorders | 150 of 407 | 50 of 204 |
| Diarrhoea | Gastrointestinal disorders | 147 of 407 | 45 of 204 |
| Nasopharyngitis | Infections and infestations | 90 of 407 | 49 of 204 |
| Vomiting | Gastrointestinal disorders | 111 of 407 | 22 of 204 |
| Upper respiratory tract infection | Infections and infestations | 85 of 407 | 44 of 204 |
| Headache | Nervous system disorders | 78 of 407 | 20 of 204 |
| Back pain | Musculoskeletal and connective tissue disorders | 53 of 407 | 22 of 204 |
| Flatulence | Gastrointestinal disorders | 47 of 407 | 23 of 204 |
| Fatigue | General disorders | 52 of 407 | 15 of 204 |
Serious events with the highest arm-level rate: cholelithiasis (1.7%), appendicitis (0.7%), cholecystitis acute (0.7%), osteoarthritis (0.7%), cervical spinal stenosis (0.5%).
The registry lists serious adverse events for the semaglutide 2.4 mg group as 37 among 407 at risk, and for the placebo group as 6 among 204 at risk. It also lists other adverse events as 379 among 407 at risk in the semaglutide group and 177 among 204 at risk in the placebo group. Deaths are listed as 0 in each group. These are descriptive figures recorded for the study; they are not a randomized comparison estimate with uncertainty.
The most frequently listed serious-event terms are cholelithiasis at 1.7%, appendicitis at 0.7%, acute cholecystitis at 0.7%, osteoarthritis at 0.7%, cervical spinal stenosis at 0.5%, and cholecystitis at 0.5%. The registry record does not give arm-specific percentages for these terms in the information, so they should not be assigned to a particular group. The listing also does not establish causation or indicate whether events were adjudicated.
General: Counts depend on the event definitions, follow-up, and the population under observation. A count alone does not describe comparative risk or precision. Interpreting group differences would require a clearly defined analysis, suitable denominators and follow-up context, and uncertainty estimates. The registry record does not report a comparative safety analysis or confidence intervals for these counts. Zero recorded deaths in each group does not establish the absence of other safety concerns.
12. What the Result Does, and Does Not, Mean
The record establishes that the trial was designed to compare semaglutide 2.4 mg plus intensive behavioural therapy with placebo plus the same program, using mean percentage change in body weight from week 0 to week 68 as the primary endpoint. It also defines the observation periods and identifies the full analysis set as the primary population. These details make the intended comparison understandable, but they are not a substitute for the outcome estimates.
The numerical primary results are not reported in the registry record. Without group summaries and a between-group estimate, it is not possible to state how much average weight change was observed, which group had the more favorable result, or how precise the comparison was. The endpoint definition does not reveal the result. Neither study completion nor the recorded enrollment indicates the direction or magnitude of an effect.
General: A trial result is best interpreted through the estimated contrast, its uncertainty, the analysis population, and the assumptions used to handle missing observations and treatment discontinuation. A result can be statistically distinguishable from a null value yet modest in magnitude, or have an estimate of potential importance but substantial uncertainty. Those distinctions cannot be evaluated without the relevant statistics. No conclusion about efficacy or lack of efficacy should be drawn from the absence of the numerical outcome in this record.
The study tested treatment in the context of an intensive behavioural program, and the brief description includes a low-calorie diet for the first 2 months. Consequently, the question described is about the added treatment strategy within that program. The record does not provide a comparison of semaglutide without behavioural support, nor a comparison of behavioural support alone with no program. The trial’s design therefore should not be recast as answering those different questions.
The safety counts are useful as a record of reported events, but they do not by themselves quantify a comparative treatment effect or establish causation. The registry lists zero deaths in each group and several serious-event terms with percentages, but supplies no comparative safety uncertainty in the material. Likewise, the presence of secondary outcomes does not disclose their results. The most defensible reading is therefore limited: the registry describes a completed randomized study and its intended analyses, while the numerical primary comparison and several key analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for the way its primary question is framed. The endpoint is a continuous measure of percentage change in body weight, compared between randomized parallel groups receiving the same intensive behavioural program. That design targets a difference between two treatment strategies rather than a change within only one group. The contrast is important because change over time in a single arm cannot, by itself, separate treatment-associated change from other influences over the observation period.
The record also makes an explicit distinction between in-trial and on-treatment observation. The in-trial period extends to the last trial-related site contact at week 75, while the on-treatment definition follows treatment intervals through week 68, includes 2 weeks of follow-up, and excludes specified temporary interruptions. Such distinctions matter because the estimand—the precise treatment effect being targeted—depends on how events after stopping or interrupting treatment are handled. The definitions are recorded, but the full estimand and analysis implementation are not.
General: Statistical interpretation depends not only on the endpoint name but also on the population, follow-up strategy, missing-data assumptions, and uncertainty estimate. A mean and standard deviation describe an outcome distribution in different ways; neither alone establishes the precision of a between-group contrast. Prespecification and transparent reporting help readers distinguish confirmatory analyses from exploratory ones, especially when many outcomes are recorded.
The registry lists a substantial range of secondary measures, including threshold-based weight outcomes and measures of waist circumference, blood pressure, physical functioning, and body mass index. This breadth can describe different dimensions of an intervention’s effects, but it also makes transparent multiplicity handling important. The record does not report that strategy. More fundamentally, the primary numerical estimate and its uncertainty are not included in the information, limiting statistical conclusions despite the detailed design and endpoint definitions.
14. 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 central limitation for interpreting this trial from the registry record is that numerical results for the primary endpoint are not reported in the material. Group means, standard deviations, the between-group estimate, confidence interval, p-value, and arm-specific numbers analyzed are absent. Without them, readers cannot assess the direction, magnitude, or precision of the primary comparison.
The endpoint description refers to both in-trial and on-treatment observation periods, but the registry does not report how those periods were incorporated into the primary analysis. The detailed estimand, model, treatment of measurements after discontinuation, and handling of temporary interruptions are not reported in the registry record. The number of participants with available endpoint data by arm and the missing-data strategy are also not reported. These omissions constrain assessment of the analysis population and the assumptions needed to interpret the estimate.
The record lists numerous outcomes and analyses but does not report the multiplicity strategy, testing hierarchy, or which outcomes were confirmatory. The statistical analysis plan, sample-size justification, interim analyses, randomization procedure, allocation concealment details, and roles included in quadruple masking are not reported in the registry record. Their absence from this record does not establish that they were absent from the conduct of the study; it means they cannot be evaluated from the information recorded.
Safety entries are descriptive and do not include comparative uncertainty estimates. The serious-event terms are listed with percentages, but the information does not specify arm-specific term estimates or enough context to infer causation. Enrollment is recorded as 611, but it should not be treated as the endpoint analysis count. Finally, the intervention was studied alongside intensive behavioural therapy and included a low-calorie diet in the study description; the record does not answer how the medication strategy would compare without that context.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program — NCT03611582.
- Registry record last updated 2021-11-11; status last verified 2021-11.
- Results first posted 2021-07-09.
- 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.
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18. Record Summary
The registry record describes a completed, randomized, quadruple-masked, parallel-group phase 3 study of semaglutide 2.4 mg versus placebo, with intensive behavioural therapy in both arms. Enrollment is recorded as 611. The primary endpoint is mean percentage change in body weight from baseline at week 0 to week 68, with standard deviation identified as the dispersion measure.
The endpoint description defines both in-trial and on-treatment observation periods and identifies the full analysis set as the population comprising all randomized participants. The number analyzed is described as the number with available data. The registry lists secondary outcomes covering weight-loss thresholds and several other health measures, alongside descriptive adverse-event counts.
Numerical primary-endpoint results and key details of the statistical analysis, missing-data handling, and multiplicity approach are not reported in the registry record. The recorded design and endpoint definitions describe the intended comparison, but do not permit an assessment of the primary effect’s direction, size, or precision.