Trial · NCT04788511
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
NCT04788511, Phase 3, Completed, Novo Nordisk A/S; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity. Trials, record NCT04788511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04788511
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
- NCT number
- NCT04788511
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 529 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Obesity
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2021-03-09
- Last updated
- 2025-12-05
- Other registries' IDs
- eudract:2019-004452-11
- Results first posted
- 2024-06-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | From baseline (week 0) to end of treatment (week 52) | The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Primary | Change in Body Weight | From baseline (week 0) to end of treatment (week 52) | Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in Six-minute Walking Distance (6MWD) | From baseline (week 0) to end of treatment (week 52) | Observed mean change from baseline (week 0) in 6 minutes walking distance (6MWD) test to end of treatment (week 52) is presented. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | From baseline (week 0) to end of study (week 57) | The hierarchical composite outcome measure from baseline (week 0) to end of study (week 57) consists of the components: time to all-cause death, number of heart failure events requiring hospitalization or urgent heart failure visit, time to first heart failure event requiring hospitalization or urgent heart failure visit, difference at least 15 in KCCQ CSS change from baseline to 52 weeks, difference at least 10 in KCCQ CSS change from baseline to 52 weeks, difference at least 5 in KCCQ CSS change from baseline to 52 weeks and difference at least 30 meters in six-minute walking distance change from baseline to 52 weeks. It was analyzed by the win-ratio approach using all participants pairs across treatment groups. Overall summary of wins in each treatment group is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Change in C-Reactive Protein (CRP): Ratio to Baseline | From baseline (week -2) to end of treatment (week 52) | Change in high sensitivity C-reactive protein measured in ratio of C-reactive protein to baseline (week -2) at end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | Percentage of participants who achieved 10% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 10% weight loss whereas 'No' infers percentage of participants who have not achieved 10% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Achieving 15% Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | Percentage of participants who achieved 15% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 15% weight loss whereas 'No' infers percentage of participants who have not achieved 15% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Achieving 20% Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | Percentage of participants who achieved 20% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 20% weight loss whereas 'No' infers percentage of participants who have not achieved 20% weight loss The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) | From baseline (week 0) to end of treatment (week 52) | Percentage of participants improving 5 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In the reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 5 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Secondary | Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) | From baseline (week 0) to end of treatment (week 52) | Percentage of participants improving 10 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 10 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Score on a scale | MEAN |
| PRIMARY | Change in Body Weight | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of body weight | MEAN |
| SECONDARY | Change in Six-minute Walking Distance (6MWD) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Meters | MEAN |
| SECONDARY | The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | From baseline (week 0) to end of study (week 57) | FAS included all the randomized participants for this trial. | Percentages of wins of participant pairs | NUMBER |
| SECONDARY | Change in C-Reactive Protein (CRP): Ratio to Baseline | From baseline (week -2) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Ratio of C-reactive protein | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 15% Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 20% Weight Loss (Yes/No) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) | From baseline (week 0) to end of treatment (week 52) | FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52. | Percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | Semaglutide 2.4 mg | 16.8 | Standard Deviation 17.9 | Score on a scale | |
| Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | Placebo | 10.3 | Standard Deviation 17.3 | Score on a scale | |
| Change in Body Weight | Semaglutide 2.4 mg | -13.9 | Standard Deviation 8.1 | Percentage of body weight | |
| Change in Body Weight | Placebo | -2.5 | Standard Deviation 5.6 | Percentage of body weight | |
| Change in Six-minute Walking Distance (6MWD) | Semaglutide 2.4 mg | 23.5 | Standard Deviation 59.2 | Meters | |
| Change in Six-minute Walking Distance (6MWD) | Placebo | 5.8 | Standard Deviation 62.7 | Meters | |
| The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | Semaglutide 2.4 mg | 60.1 | Percentages of wins of participant pairs | ||
| The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | Placebo | 34.9 | Percentages of wins of participant pairs | ||
| Change in C-Reactive Protein (CRP): Ratio to Baseline | Semaglutide 2.4 mg | 0.55 | Geometric Coefficient of Variation 121.5 | Ratio of C-reactive protein | |
| Change in C-Reactive Protein (CRP): Ratio to Baseline | Placebo | 0.92 | Geometric Coefficient of Variation 105.3 | Ratio of C-reactive protein |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide 2.4 mg | 263 | |
| Overall Study | STARTED | Placebo | 266 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 263 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 266 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 263 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 266 | |
| Overall Study | COMPLETED | Semaglutide 2.4 mg | 256 | |
| Overall Study | COMPLETED | Placebo | 254 | |
| Overall Study | NOT COMPLETED | Semaglutide 2.4 mg | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events230
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 2.4 mg | 36 | 263 | 36 |
| other | COVID-19 | Infections and infestations | Placebo | 41 | 266 | 43 |
| other | Constipation | Gastrointestinal disorders | Semaglutide 2.4 mg | 17 | 263 | 18 |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 266 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Semaglutide 2.4 mg | 24 | 263 | 28 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 10 | 266 | 16 |
| other | Nausea | Gastrointestinal disorders | Semaglutide 2.4 mg | 45 | 263 | 51 |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 266 | 8 |
| other | Vomiting | Gastrointestinal disorders | Semaglutide 2.4 mg | 17 | 263 | 22 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 266 | 3 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide 2.4 mg | 3 | 263 |
| Total, all-cause mortality | Placebo | 4 | 266 |
| Total, other adverse events | Semaglutide 2.4 mg | 93 | 263 |
| Total, other adverse events | Placebo | 57 | 266 |
| Total, serious adverse events | Semaglutide 2.4 mg | 35 | 263 |
| Total, serious adverse events | Placebo | 71 | 266 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide 2.4 mg vs Placebo: deaths from any cause | Trial comparisons |
| Semaglutide 2.4 mg vs Placebo: serious adverse events | Trial comparisons |
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
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/NCT04788511
GET https://conductscience.org/api/trials/v1/NCT04788511/results?page=2