Trial · NCT03552757
Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
NCT03552757, Phase 3, Completed, Novo Nordisk A/S; results first posted 2021-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity. Trials, record NCT03552757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03552757
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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 With Type 2 Diabetes Suffering From Overweight or Obesity
- NCT number
- NCT03552757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,210 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Obesity, Overweight
- Interventions
- Semaglutide 1.0 mg, Semaglutide 2.4 mg, Placebo I (Semaglutide), Placebo II (Semaglutide)
- First posted
- 2018-06-12
- Last updated
- 2021-11-09
- Other registries' IDs
- eudract:2017-003414-10
- Results first posted
- 2021-08-11
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Baseline (week 0) to week 68 | Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
| Primary | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | At week 68 | Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. |
| Secondary | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg | Baseline (week 0) to week 68 | Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg | At week 68 | Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Change in Waist Circumference | Baseline (week 0) to week 68 | Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Change in Body Weight (Kg) | Baseline (week 0) to week 68 | Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Change in BMI | Baseline (week 0) to week 68 | Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% | At week 68 | Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% | At week 68 | Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% | At week 68 | Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Baseline (week 0) to week 68 | Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data. | Percentage point of body weight | MEAN |
| PRIMARY | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | At week 68 | Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Percentage point of body weight | MEAN |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg | At week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Waist Circumference | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Centimetre (cm) | MEAN |
| SECONDARY | Change in Body Weight (Kg) | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Kilogram (kg) | MEAN |
| SECONDARY | Change in BMI | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | kilogram per square meter (kg/m^2) | MEAN |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% | At week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% | At week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% | At week 68 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group191
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Semaglutide 2.4 mg | In-trial observation period | -9.9 | Standard Deviation 8.0 | Percentage point of body weight |
| Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Placebo | In-trial observation period | -3.3 | Standard Deviation 5.5 | Percentage point of body weight |
| Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Semaglutide 2.4 mg | On-treatment observation period | -10.7 | Standard Deviation 7.8 | Percentage point of body weight |
| Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo | Placebo | On-treatment observation period | -3.1 | Standard Deviation 5.2 | Percentage point of body weight |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Semaglutide 2.4 mg | In-trial observation period / Yes | 267 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Placebo | In-trial observation period / Yes | 107 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Semaglutide 2.4 mg | In-trial observation period / No | 121 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Placebo | In-trial observation period / No | 269 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Semaglutide 2.4 mg | On-treatment observation period / Yes | 257 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo | Placebo | On-treatment observation period / Yes | 94 | Participants |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide 1.0 mg | 403 | |
| Overall Study | STARTED | Semaglutide 2.4 mg | 404 | |
| Overall Study | STARTED | Placebo | 403 | |
| Overall Study | Exposed | Semaglutide 1.0 mg | 402 | |
| Overall Study | Exposed | Semaglutide 2.4 mg | 403 | |
| Overall Study | Exposed | Placebo | 402 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 1.0 mg | 403 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 404 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 403 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 1.0 mg | 402 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events426
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 1.0 mg | 9 | 402 | 12 |
| other | Abdominal distension | Gastrointestinal disorders | Semaglutide 2.4 mg | 24 | 403 | 30 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 11 | 402 | 13 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Semaglutide 1.0 mg | 24 | 402 | 27 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Semaglutide 2.4 mg | 23 | 403 | 29 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 20 | 402 | 20 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Semaglutide 1.0 mg | 28 | 402 | 30 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Semaglutide 2.4 mg | 27 | 403 | 30 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 14 | 402 | 15 |
| other | Constipation | Gastrointestinal disorders | Semaglutide 1.0 mg | 51 | 402 | 70 |
1 to 10 of 426Source ClinicalTrials.gov
See all 426 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide 1.0 mg | 1 | 402 |
| Total, all-cause mortality | Semaglutide 2.4 mg | 1 | 403 |
| Total, all-cause mortality | Placebo | 1 | 402 |
| Total, other adverse events | Semaglutide 1.0 mg | 261 | 402 |
| Total, other adverse events | Semaglutide 2.4 mg | 284 | 403 |
| Total, other adverse events | Placebo | 190 | 402 |
| Total, serious adverse events | Semaglutide 1.0 mg | 31 | 402 |
| Total, serious adverse events | Semaglutide 2.4 mg | 40 | 403 |
| Total, serious adverse events | Placebo | 37 | 402 |
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.
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