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 Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (NCT03693430), a randomized phase 3 study. The primary outcome is Percentage Change From Baseline (Week 0) to Week 104 in Body Weight.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03693430 |
| Phase | Phase 3 |
| Condition | Overweight, Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 304 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novo Nordisk A/S |
| Results posted | Yes |
2. Clinical Question
Population
People with overweight or obesity. The registry record does not report further population characteristics in the registry record for this analysis, such as age or other eligibility details.
Intervention
Semaglutide 2.4 mg once weekly during a 104-week treatment period, in addition to a reduced-calorie diet and increased physical activity. The study description says participants were to receive a weekly injection.
Comparator
Placebo during a 104-week treatment period, also alongside a reduced-calorie diet and increased physical activity. Treatment assignment was by chance.
Primary question
What percentage change in body weight from baseline, at week 104, was observed with semaglutide compared with placebo? The endpoint description covers both in-trial and on-treatment observation periods. The numerical group results and comparison are not reported in the registry record.
The central statistical question is a comparison between randomized groups, not whether participants in either group changed from their own baseline in isolation. Random assignment is intended to make the groups comparable on average at the start of the trial. The registry record describes a quadruple-masked, parallel-group design and lists 304 participants enrolled. Both groups also received lifestyle measures, so the study question concerns the added study treatment in that shared context, rather than semaglutide in the absence of diet and activity support.
The primary outcome is expressed as percentage change rather than only as an absolute change in body weight. That scale describes change relative to baseline weight. However, the registry record does not report the group estimates, their uncertainty, or a single treatment contrast in the registry record for this analysis. As a result, the statistical question can be described, but the size and precision of the observed difference cannot be stated.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group phase 3 study sponsored by Novo Nordisk A/S. The registry record lists 304 participants enrolled and describes the study as completed. The recorded start date is 2018-10-05, and the primary completion date is 2021-01-29. These dates describe the registry timeline; they do not, by themselves, provide additional information about individual participation or follow-up.
Participants were assigned by chance to semaglutide or placebo. The semaglutide arm received 2.4 mg during a 104-week treatment period, and the placebo arm received placebo over the same period. Both arms also received a reduced-calorie diet and increased physical activity. The brief study description adds that participants were to take one injection once a week and describes a study lasting about two years, with 19 clinic visits and 15 phone calls with the study doctor.
Masking is recorded as quadruple. The registry record does not identify which specific roles were masked, so those roles should not be inferred from the masking label. Likewise, randomization is reported, but the method used to generate the allocation sequence and the allocation concealment procedure are not reported in the registry record. The record identifies two intervention groups, but does not report the planned allocation ratio in the registry record.
The primary endpoint was percentage change in body weight from baseline at week 104. The endpoint description refers to both an in-trial observation period and an on-treatment observation period. The in-trial period is described as running from randomization to last contact with the trial site. The on-treatment period is described as running from first to last trial product administration, plus two weeks of follow-up, while excluding a temporary interruption defined as more than two consecutive missed doses. These definitions show that the endpoint description distinguishes observation according to trial contact and treatment exposure; they do not establish which result should be preferred for every interpretation.
Other listed outcomes include body-weight reduction thresholds of 10%, 15%, and 20%, changes in waist circumference, body weight, body mass index, and blood pressure. The registry lists 37 outcome measures and four analyses. Details of the full protocol, the planned statistical model, and the rationale for the enrollment target 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.
Before assignment: Participants were randomized in a 1:1 manner to receive treatment with semaglutide 2.4 milligram (mg) or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 104 weeks treatment period (16 weeks of dose escalation period and 88 weeks of maintenance dose).
Overall Study
| Stage | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| STARTED | 152 | 152 |
| Full Analysis Set (FAS) | 152 | 152 |
| Safety Analysis Set (SAS) | 152 | 152 |
| COMPLETED | 148 | 134 |
| NOT COMPLETED | 4 | 18 |
Reasons for not completing this period:
| Reason | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Lost to Follow-up | 3 | 14 |
| Death | 1 | 0 |
| Withdrawal by Subject | 0 | 4 |
Analysis population for the primary outcome, as defined in the registry: The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.
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: The full analysis set (FAS) included all randomised participants according to the intention-to-treat principle.
| Characteristic | Unit | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 152 | 152 | 304 | |
| Age, Continuous | years | 47 (SD 12) | 47 (SD 10) | 47 (SD 11) |
| Sex: Female, Male: Female | Participants | 123 | 113 | 236 |
| Sex: Female, Male: Male | Participants | 29 | 39 | 68 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 18 | 21 | 39 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 134 | 131 | 265 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 141 | 142 | 283 |
| Race/Ethnicity, Customized: Black or African American | Participants | 7 | 5 | 12 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 4 | 4 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage Change From Baseline (Week 0) to Week 104 in Body Weight, measured over From Baseline (Week 0) to Week 104.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint measures percentage change in body weight from baseline, identified as week 0, to week 104. A percentage-change scale expresses change relative to a participant’s starting weight, whereas a change in kilograms would express the absolute amount of weight change. The registry also lists change in body weight in kilograms as a secondary outcome, so the two measures address related but distinct descriptions of weight change.
The endpoint description says that results are presented for both in-trial and on-treatment observation periods. The in-trial period extends from randomization to last contact with the trial site. The on-treatment period extends from first to last study-product administration, with two weeks of follow-up, and excludes temporary interruptions defined as more than two consecutive missed doses. These definitions matter because observations can be classified according to whether they occurred during trial follow-up or around active treatment exposure.
In general, a continuous endpoint such as percentage change can retain information across the range of observed changes, rather than reducing each participant to a yes-or-no category. The mean is the stated parameter for this endpoint, and the standard deviation is the stated dispersion measure. In general, the mean describes the average value in a group, while the standard deviation describes how spread out individual values are around that average.
The registry record does not report the numerical endpoint estimates, standard deviations, confidence intervals, or a single group comparison in the registry record for this analysis. Therefore, the endpoint’s definition and intended measurement can be described, but its observed magnitude and precision cannot.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of semaglutide 2.4 mg once weekly with placebo, with both groups receiving reduced-calorie diet and increased physical activity. The primary outcome is percentage change in body weight from baseline to week 104. These details establish the clinical and statistical question, but the numerical outcome estimates needed to answer that question are not reported in the registry record. There is no group mean, treatment contrast, standard deviation, or confidence interval in the registry record for this analysis.
Without those estimates, the magnitude and direction of the observed difference cannot be characterized. It is not possible to state how much body weight changed on average in either group, how far apart the group estimates were, or how precisely the comparison was estimated. The record’s identification of a primary endpoint does not substitute for its numerical results. Nor can any conclusion about the endpoint be drawn from the fact that the study is marked completed.
The endpoint description includes both in-trial and on-treatment observation periods. These are different ways of defining which observations contribute to an analysis: one follows participants through their last trial-site contact, while the other focuses on a period associated with study-product administration and specified follow-up. The registry entries do not give the numerical results for either period. They also do not establish that one observation period is more relevant than the other for every question.
The registry lists secondary outcomes that include weight-loss thresholds and changes in waist circumference, body mass index, and blood pressure. Their presence indicates that the study registered more than one outcome measure; it does not show what the results were. The numerical findings for these outcomes are not reported in the registry record. No inference about those outcomes should be made from the primary outcome definition or from the listed endpoint names alone.
Safety figures are available for serious adverse events and deaths. The registry lists 12 participants with serious adverse events among 152 at risk in the semaglutide group and 18 among 152 at risk in the placebo group. It lists one death in the semaglutide group and zero in the placebo group. These are descriptive counts in the recorded groups. They do not, by themselves, determine whether a difference was caused by treatment, and the registry entries do not give a formal statistical comparison or detailed causal assessment.
In general, statistical interpretation considers both the estimated effect and its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data under the assumptions of the analysis. Here, no confidence interval for the primary comparison is reported in the registry record, so precision cannot be assessed. The record also does not report the statistical model or a multiplicity procedure. The most defensible interpretation is therefore limited: the trial design and endpoints are described, and some safety counts are listed, but the primary efficacy estimate and its uncertainty are not available in the registry entries for this analysis.
9. Statistical Methods Explained
The primary endpoint is a continuous measure, and the stated parameter is the mean. In general, a continuous outcome can take a range of values rather than only categories such as yes or no. A mean gives a group-level average, while a standard deviation describes the spread of participant values around that average. The registry identifies standard deviation as the dispersion measure for the primary endpoint, but numerical means and standard deviations are not reported in the registry record in the registry record for this analysis.
What does the randomized comparison estimate?
In general, a randomized trial compares outcomes between groups assigned to different study interventions. Random assignment helps reduce systematic differences between groups at baseline, on average, although it does not ensure that every characteristic is identical. The registry describes random assignment to semaglutide or placebo and a parallel-group design, in which participants remain associated with their assigned group for the comparison. It does not report the randomization sequence method, concealment process, or statistical model used to estimate the primary comparison.
The primary endpoint is percentage change in body weight from baseline to week 104. A comparison could be expressed as a difference between group means, but the registry entries do not include a numerical contrast. No such contrast should be reconstructed from the endpoint title alone. The registry also does not report a confidence interval or p-value for this endpoint in the registry entries.
Why are observation periods defined separately?
The record distinguishes an in-trial observation period from an on-treatment observation period. The in-trial period runs from randomization to last contact with the trial site. The on-treatment period runs from first to last trial product administration plus two weeks of follow-up, excluding temporary interruption periods defined as more than two consecutive missed doses. In general, these definitions can lead to different sets of observations because participants may stop treatment before their final trial contact, or may have gaps in treatment. The record does not provide the number of observations contributing to each period or numerical results by period.
In general, defining an analysis period helps clarify which measurements are being summarized. It does not, by itself, explain how missing measurements were handled, whether values after treatment discontinuation were included, or how all deviations from the planned treatment course were addressed. Those details are not reported in the registry record in the registry record for this analysis.
How should uncertainty be understood?
In general, a confidence interval communicates uncertainty around an estimated quantity. A narrower interval indicates greater precision under the analysis assumptions, while a wider interval indicates less precision. A confidence interval is not a guarantee that the true value lies in the particular interval, and it does not address every possible source of bias. No confidence interval for the primary outcome is reported in the registry entries, so its precision cannot be evaluated.
In general, a p-value assesses how compatible the observed data are with a specified null hypothesis under a statistical model. It does not measure the size or clinical importance of an effect, and it is not the probability that the null hypothesis is true. The registry record does not report a primary-outcome p-value in the registry record for this analysis. Without an estimate and its uncertainty, neither statistical significance nor the range of plausible effects can be assessed.
What does the analysis population mean?
The primary outcome description states that the FAS included all randomized participants according to the intention-to-treat principle. It also says that the overall number analyzed consists of participants with available data for the outcome, and that the number analyzed for each specified category consists of participants with available data in that category. In general, intention-to-treat analysis aims to retain participants in the groups to which they were randomized, regardless of treatment changes. The availability wording also makes clear that not every randomized participant necessarily contributed an observed value to every endpoint summary. The number with available primary-outcome data is not reported in the registry record in the registry record.
In general, missing data can affect estimates if the chance that a measurement is missing is related to the outcome or to participant characteristics. Different assumptions and methods for handling missing values can produce different estimates. The registry record does not report the missing-data method, assumptions about missingness, or sensitivity analyses for the primary endpoint in the registry record for this analysis.
What can planning calculations tell us?
In general, a sample-size calculation is a planning exercise based on assumptions about an effect, variability, significance level, allocation, and analysis method. The planning illustration associated with this trial is described as using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It is explicitly a planning illustration based on the observed effect, not the trial’s own design. Its assumptions should not be mistaken for documented protocol choices.
In general, “observed power” is not a substitute for reporting an effect estimate and confidence interval. A planning calculation does not establish that the trial was adequately powered for every outcome, nor does it describe the precision actually achieved. The registry entries do not include the numeric planning outputs, and the registry record does not report the trial’s sample-size justification or its own planned assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 37 outcome measures and four analyses. The primary endpoint description refers to both in-trial and on-treatment observation periods, and the primary outcome has several categories or time points rather than a single reduced comparison. These features mean that interpretation depends on knowing which result addresses the primary question and how other analyses were treated. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting the several outcomes and analyses.
In general, when many outcomes, time points, or comparisons are tested, the chance of at least one apparently unusual result can increase if each is treated as a separate confirmatory test. Multiplicity procedures can help control that issue, but they may also affect the interpretation of individual comparisons. The registry entries do not identify a procedure, so it is not possible to say whether or how multiplicity was handled.
The outcome description says the FAS included all randomized participants according to the intention-to-treat principle. It further defines the number analyzed as participants with available data for the outcome or specified category. This describes the analysis population principle and availability requirement, but does not report how many participants had data at week 104 or how missing measurements were handled.
In general, missingness can reduce precision and can introduce bias when the probability of an outcome being missing is related to the outcome itself or to other relevant characteristics. Methods may include assumptions about unobserved values and sensitivity analyses to examine whether conclusions change under alternative assumptions. The registry record does not report the missing-data method, missingness assumptions, or sensitivity analyses in the registry record for this analysis.
The statistical analysis plan, including any prespecified handling of multiplicity, interim analyses, and missing data, is not reported in the registry record. No interim analysis should be inferred from the number of analyses listed. The registry entries support describing the registered outcome and population definitions, but not reconstructing unreported analysis decisions.
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 | 12 | 152 | 7.9% |
| Placebo | 18 | 152 | 11.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Semaglutide 2.4 mg | 1 of 152 |
| Placebo | 0 of 152 |
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 | 141 of 152 |
| Placebo | 117 of 152 |
Most frequent serious adverse event terms
| Event term | Organ system | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| COVID-19 | Infections and infestations | 1 of 152 | 2 of 152 |
| Cholelithiasis | Hepatobiliary disorders | 2 of 152 | 0 of 152 |
| Foot deformity | Musculoskeletal and connective tissue disorders | 1 of 152 | 1 of 152 |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 152 | 2 of 152 |
| Abdominal adhesions | Gastrointestinal disorders | 1 of 152 | 0 of 152 |
| Acute myocardial infarction | Cardiac disorders | 1 of 152 | 0 of 152 |
| Anal abscess | Infections and infestations | 0 of 152 | 1 of 152 |
| Appendicitis | Infections and infestations | 0 of 152 | 1 of 152 |
| Appendicitis perforated | Infections and infestations | 1 of 152 | 0 of 152 |
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | 0 of 152 | 1 of 152 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 81 of 152 | 33 of 152 |
| Diarrhoea | Gastrointestinal disorders | 53 of 152 | 36 of 152 |
| Constipation | Gastrointestinal disorders | 47 of 152 | 17 of 152 |
| Vomiting | Gastrointestinal disorders | 46 of 152 | 7 of 152 |
| Nasopharyngitis | Infections and infestations | 24 of 152 | 23 of 152 |
| Upper respiratory tract infection | Infections and infestations | 20 of 152 | 23 of 152 |
| Influenza | Infections and infestations | 20 of 152 | 16 of 152 |
| Back pain | Musculoskeletal and connective tissue disorders | 15 of 152 | 19 of 152 |
| Abdominal pain upper | Gastrointestinal disorders | 22 of 152 | 10 of 152 |
| Headache | Nervous system disorders | 16 of 152 | 16 of 152 |
Serious events with the highest arm-level rate: covid-19 (1.3%), cholelithiasis (1.3%), invasive ductal breast carcinoma (1.3%), abdominal adhesions (0.7%), acute myocardial infarction (0.7%).
The registry lists serious adverse events for two groups, each with 152 participants at risk. In the semaglutide 2.4 mg group, 12 participants were affected; in the placebo group, 18 were affected. The registry also lists one death in the semaglutide group and zero in the placebo group. These counts describe what was recorded in the groups and should be read as safety summaries, not as proof that treatment caused or prevented an event.
The registry lists serious adverse event terms with percentages: COVID-19, 1.3%; cholelithiasis, 1.3%; invasive ductal breast carcinoma, 1.3%; abdominal adhesions, 0.7%; acute myocardial infarction, 0.7%; and anal abscess, 0.7%. The registry entries do not identify the treatment group for each listed term or provide further event-level details. These percentages should therefore not be assigned to a particular arm or interpreted as comparative risks.
In general, adverse-event counts require context, including how events were defined, collected, and attributed, and whether participants could experience more than one event. The registry entries do not provide those details or a formal comparison of serious adverse events between groups. The counts alone also do not establish a causal relationship. They are descriptive information from the registry record, and should not be treated as a complete account of all possible safety outcomes.
12. What the Result Does, and Does Not, Mean
The trial record describes a randomized, quadruple-masked comparison of semaglutide 2.4 mg once weekly with placebo, with both groups receiving reduced-calorie diet and increased physical activity. It identifies percentage change in body weight from baseline to week 104 as the primary endpoint and states that the analysis concerns in-trial and on-treatment observation periods. These details clarify the intended comparison and the endpoint’s timing.
The numerical primary results are not reported in the registry record in the registry record for this analysis. Consequently, the magnitude and direction of the primary comparison, and the precision of its estimate, cannot be described. The endpoint name alone cannot establish what the study found. The study’s completed status and enrollment count do not provide a substitute for group outcome estimates.
The listed secondary outcomes show that the study registered additional measures, including threshold-based weight reduction outcomes and changes in waist circumference, body mass index, and blood pressure. The registry entries do not report their numerical results. Their presence should not be taken as evidence of a particular pattern of findings.
The safety information includes serious adverse event counts, deaths, and several listed event terms with percentages. These provide descriptive counts and labels, but do not identify a causal relationship or establish a comparative safety conclusion. The registry entries do not provide the statistical comparison, detailed attribution, or event-level context needed for broader conclusions.
In general, a treatment estimate and its uncertainty are needed to distinguish a large, precisely estimated difference from a small or uncertain one. A confidence interval can help show the range of effects compatible with the data under the analysis assumptions, but no primary-outcome interval is reported in the registry record. The statistical analysis plan, sample-size justification, and missing-data procedures are also not reported in the registry record. Interpretation should therefore remain limited to the design, registered outcomes, analysis-population description, and descriptive safety figures that are stated.
13. Why This Trial Matters Statistically
This study illustrates why a trial’s design and outcome definition are only part of the statistical evidence. Random assignment, masking, a parallel-group structure, and a specified week-104 endpoint help define how the comparison was organized. The shared lifestyle measures also make clear that the intended contrast is between semaglutide and placebo within a program that included diet and physical activity support.
The primary outcome is continuous and expressed as percentage change from baseline. In general, this scale can preserve information about the range of participants’ changes, while the registry’s secondary threshold outcomes describe whether particular percentage reductions were reached. These answer different statistical questions: an average change characterizes the group distribution in one way, and a threshold count characterizes the proportion crossing a defined boundary. The registry lists the thresholds but does not report their numerical results in the registry record for this analysis.
The distinction between in-trial and on-treatment observation periods is also statistically important. In general, outcomes can differ depending on whether the analysis follows participants through trial contact or focuses on treatment exposure and its defined follow-up. Clear period definitions help readers understand what observations are intended to represent, but do not remove the need to report estimates, uncertainty, and missing-data handling.
Finally, the registry record lists a substantial set of outcome measures and analyses, while the detailed statistical plan and multiplicity handling are not reported. This highlights the importance of transparent prespecification and complete result reporting when several outcomes or analysis periods are considered. The record supports a clear description of the research question and design, but the primary numerical findings and their precision are unavailable in the registry record for this analysis.
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.
A central limitation for interpreting this trial record is that the numerical primary outcome results are not reported in the registry record for this analysis. No group means, standard deviations, treatment contrast, confidence interval, or p-value are available. This prevents assessment of the size, direction, and precision of the primary comparison.
The primary outcome description refers to both in-trial and on-treatment observation periods and notes several categories or time points. A single comparison is not reduced from those results in the registry record. The registry record does not report which period or analysis should be treated as the primary interpretive result, or provide the estimates needed to compare periods.
The outcome description states that the FAS includes randomized participants under the intention-to-treat principle, while the number analyzed depends on data availability. The count of participants with available primary-outcome data is not reported in the registry record in the registry record for this analysis. Nor are the missing-data method, assumptions, or sensitivity analyses reported. Those omissions limit assessment of how incomplete measurements may affect interpretation.
The registry lists 37 outcome measures and four analyses, but the statistical plan and multiplicity procedure are not reported. The registry entries also do not report a sample-size justification, interim-analysis plan, randomization method, or allocation concealment procedure. These details should not be inferred from the design labels or the planning illustration.
Safety information is also limited to descriptive counts and listed terms. The registry entries do not identify the treatment group for each serious adverse event term, give a formal comparative analysis, or describe event attribution. The listed safety figures therefore cannot support a full causal assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity — NCT03693430.
- Registry record last updated 2023-07-06; status last verified 2023-07.
- Results first posted 2022-03-23.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry record describes a completed phase 3, randomized, quadruple-masked, parallel-group study sponsored by Novo Nordisk A/S. It lists 304 participants enrolled, with a recorded start date of 2018-10-05 and primary completion date of 2021-01-29. The groups received semaglutide 2.4 mg or placebo during a 104-week treatment period, alongside reduced-calorie diet and increased physical activity.
The primary endpoint was percentage change in body weight from baseline to week 104, with the outcome description covering in-trial and on-treatment periods. The primary results are not reported in the registry record in the registry record for this analysis. The record lists 37 outcome measures and four analyses; detailed statistical methods, missing-data procedures, multiplicity handling, and the sample-size justification are not reported in the registry entries.
Safety summaries list 12 serious adverse event-affected participants among 152 at risk in the semaglutide group and 18 among 152 at risk in the placebo group, alongside one and zero deaths, respectively. These are descriptive figures, not a causal comparison.