Trial · NCT03548987
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
NCT03548987, Phase 3, Completed, Novo Nordisk A/S; results first posted 2021-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity. Trials, record NCT03548987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03548987
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
- NCT number
- NCT03548987
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 902 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- Semaglutide, Placebo
- First posted
- 2018-06-07
- Last updated
- 2022-01-19
- Other registries' IDs
- eudract:2017-003473-34
- Results first posted
- 2021-03-15
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Randomisation to Week 68 in Body Weight (%) | Randomisation (week 20) to week 68 | Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Secondary | Change in Waist Circumference | Randomization (week 20) to week 68 | Change in waist circumference from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Systolic Blood Pressure | Randomization (week 20) to week 68 | Change in systolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Diastolic Blood Pressure | Randomization (week 20) to week 68 | Change in diastolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Physical Functioning Score (Short Form 36 [SF-36]) | Randomization (week 20) to week 68 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 20 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Body Weight [Kilogram (Kg)] | Randomisation (week 20) to week 68 | Change in body weight from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Body Mass Index (BMI) | Randomization (week 20) to week 68 | Change in BMI from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Haemoglobin A1c (HbA1c) [%] | Randomization (week 20) to week 68 | Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in HbA1c [Millimoles Per Mole (mmol/Mol)] | Randomization (week 20) to week 68 | Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)] | Randomization (week 20) to week 68 | Change in fasting plasma glucose from week 20 to week 68 is presented.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Randomisation to Week 68 in Body Weight (%) | Randomisation (week 20) to week 68 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = participants with available data. | Percentage point | MEAN |
| SECONDARY | Change in Waist Circumference | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Centimeter (cm) | MEAN |
| SECONDARY | Change in Systolic Blood Pressure | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | mmHg | MEAN |
| SECONDARY | Change in Physical Functioning Score (Short Form 36 [SF-36]) | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Scores on a scale | MEAN |
| SECONDARY | Change in Body Weight [Kilogram (Kg)] | Randomisation (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Kg | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Kilogram per square meter (kg/sqm) | MEAN |
| SECONDARY | Change in Haemoglobin A1c (HbA1c) [%] | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Percentage point of HbA1c | MEAN |
| SECONDARY | Change in HbA1c [Millimoles Per Mole (mmol/Mol)] | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | mmol/mol | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)] | Randomization (week 20) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | mg/dL | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Randomisation to Week 68 in Body Weight (%) | Semaglutide 2.4 mg | In-trial | -8.3 | Standard Deviation 8.1 | Percentage point |
| Change From Randomisation to Week 68 in Body Weight (%) | Placebo | In-trial | 6.5 | Standard Deviation 7.7 | Percentage point |
| Change From Randomisation to Week 68 in Body Weight (%) | Semaglutide 2.4 mg | On-treatment | -8.8 | Standard Deviation 7.8 | Percentage point |
| Change From Randomisation to Week 68 in Body Weight (%) | Placebo | On-treatment | 6.1 | Standard Deviation 7.7 | Percentage point |
| Change in Waist Circumference | Semaglutide 2.4 mg | -6.9 | Standard Deviation 7.5 | Centimeter (cm) | |
| Change in Waist Circumference | Placebo | 3.2 | Standard Deviation 7.0 | Centimeter (cm) | |
| Change in Systolic Blood Pressure | Semaglutide 2.4 mg | 0 | Standard Deviation 14 | Millimeters of mercury (mmHg) | |
| Change in Systolic Blood Pressure | Placebo | 5 | Standard Deviation 13 | Millimeters of mercury (mmHg) | |
| Change in Diastolic Blood Pressure | Semaglutide 2.4 mg | 0 | Standard Deviation 9 | mmHg | |
| Change in Diastolic Blood Pressure | Placebo | 1 | Standard Deviation 9 | mmHg |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period (Week 0 to Week 20) | STARTED | Semaglutide 2.4 mg | 902 | |
| Run-in Period (Week 0 to Week 20) | STARTED | Placebo | 0 | |
| Run-in Period (Week 0 to Week 20) | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 902 | |
| Run-in Period (Week 0 to Week 20) | Safety Analysis Set (SAS) | Placebo | 0 | |
| Run-in Period (Week 0 to Week 20) | COMPLETED | Semaglutide 2.4 mg | 803 | |
| Run-in Period (Week 0 to Week 20) | COMPLETED | Placebo | 0 | |
| Run-in Period (Week 0 to Week 20) | NOT COMPLETED | Semaglutide 2.4 mg | 99 | |
| Run-in Period (Week 0 to Week 20) | NOT COMPLETED | Placebo | 0 | |
| Maintenance Period (Week 20 to Week 68) | STARTED | Semaglutide 2.4 mg | 535 | |
| Maintenance Period (Week 20 to Week 68) | STARTED | Placebo | 268 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events264
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide: Run-in Period | 50 | 902 | 53 |
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide 2.4: Treatment Period | 8 | 535 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo: Treatment Period | 2 | 268 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide: Run-in Period | 67 | 902 | 82 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide 2.4: Treatment Period | 34 | 535 | 45 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo: Treatment Period | 8 | 268 | 9 |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide: Run-in Period | 49 | 902 | 64 |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide 2.4: Treatment Period | 20 | 535 | 22 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo: Treatment Period | 3 | 268 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Semaglutide: Run-in Period | 21 | 902 | 23 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide: Run-in Period | 0 | 902 |
| Total, all-cause mortality | Semaglutide 2.4: Treatment Period | 1 | 535 |
| Total, all-cause mortality | Placebo: Treatment Period | 1 | 268 |
| Total, other adverse events | Semaglutide: Run-in Period | 670 | 902 |
| Total, other adverse events | Semaglutide 2.4: Treatment Period | 295 | 535 |
| Total, other adverse events | Placebo: Treatment Period | 114 | 268 |
| Total, serious adverse events | Semaglutide: Run-in Period | 21 | 902 |
| Total, serious adverse events | Semaglutide 2.4: Treatment Period | 41 | 535 |
| Total, serious adverse events | Placebo: Treatment Period | 15 | 268 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03548987
GET https://conductscience.org/api/trials/v1/NCT03548987/registered?page=2