Trial · NCT03574597
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
NCT03574597, Phase 3, Completed, Novo Nordisk A/S; results first posted 2024-08-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity. Trials, record NCT03574597. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03574597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
- NCT number
- NCT03574597
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 17,604 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Overweight, Obesity
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2018-07-02
- Last updated
- 2024-08-30
- Other registries' IDs
- eudract:2017-003380-35
- Results first posted
- 2024-08-30
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to CV Death | From randomisation (week 0) up to 240 weeks | Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to All-cause Death | From randomisation (week 0) up to 240 weeks | Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of Non-fatal MI | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to CV Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to All-cause Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Non-fatal MI | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | Semaglutide | 569 | Participants | ||
| Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | Placebo | 701 | Participants | ||
| Participants From Time of Randomisation to CV Death | Semaglutide | 223 | Participants | ||
| Participants From Time of Randomisation to CV Death | Placebo | 262 | Participants | ||
| Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | Semaglutide | 300 | Participants | ||
| Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | Placebo | 361 | Participants | ||
| Participants From Time of Randomisation to All-cause Death | Semaglutide | 375 | Participants | ||
| Participants From Time of Randomisation to All-cause Death | Placebo | 458 | Participants | ||
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | Semaglutide | 873 | Participants | ||
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | Placebo | 1074 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 8,803 | |
| Overall Study | STARTED | Placebo | 8,801 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide | 8,803 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 8,801 | |
| Overall Study | COMPLETED | Semaglutide | 8,544 | |
| Overall Study | COMPLETED | Placebo | 8,517 | |
| Overall Study | NOT COMPLETED | Semaglutide | 259 | |
| Overall Study | NOT COMPLETED | Placebo | 284 |
Source ClinicalTrials.gov
Adverse events3,536
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 | COVID-19 | Infections and infestations | Semaglutide | 1,787 | 8,803 | 1,933 |
| other | COVID-19 | Infections and infestations | Placebo | 1,785 | 8,801 | 1,935 |
| other | Constipation | Gastrointestinal disorders | Semaglutide | 715 | 8,803 | 855 |
| other | Constipation | Gastrointestinal disorders | Placebo | 231 | 8,801 | 256 |
| other | Decreased appetite | Metabolism and nutrition disorders | Semaglutide | 585 | 8,803 | 655 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 112 | 8,801 | 123 |
| other | Diarrhoea | Gastrointestinal disorders | Semaglutide | 933 | 8,803 | 1,417 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 353 | 8,801 | 429 |
| other | Dyspepsia | Gastrointestinal disorders | Semaglutide | 468 | 8,803 | 629 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 94 | 8,801 | 102 |
1 to 10 of 3,536Source ClinicalTrials.gov
See all 3,536 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 371 | 8,803 |
| Total, all-cause mortality | Placebo | 460 | 8,801 |
| Total, other adverse events | Semaglutide | 3,944 | 8,803 |
| Total, other adverse events | Placebo | 2,440 | 8,801 |
| Total, serious adverse events | Semaglutide | 2,941 | 8,803 |
| Total, serious adverse events | Placebo | 3,204 | 8,801 |
Source ClinicalTrials.gov
Papers22
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 comparisons16
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%]) | Trial comparisons |
Semaglutide vs Placebo: Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to CV Death | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | Trial comparisons |
| Semaglutide vs Placebo: Participants From Time of Randomisation to First Occurrence of Non-fatal MI | Trial comparisons |
1 to 10 of 16
See all 16 trial comparisonsTests0
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03574597
GET https://conductscience.org/api/trials/v1/NCT03574597/registered?page=2