Trial · NCT05040971
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
NCT05040971, Phase 3, Completed, Novo Nordisk A/S; results first posted 2024-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes. Trials, record NCT05040971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05040971
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
- NCT number
- NCT05040971
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 207 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Obesity
- Interventions
- Semaglutide 2.4 mg, Placebo
- First posted
- 2021-09-10
- Last updated
- 2026-01-29
- Other registries' IDs
- eudract:2020-002939-29
- Results first posted
- 2024-10-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight (Percentage [%]) | From randomisation (week 0) to end of treatment (week 52) | Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Primary | Participants With Change to Normoglycemia | At week 52 | Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L. |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | From randomisation (week 0) to end of treatment (week 52) | Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Fasting Plasma Glucose (FPG) | From randomisation (week 0) to end of treatment (week 52) | Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Waist Circumference | From randomisation (week 0) to end of treatment (week 52) | Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Systolic Blood Pressure | From randomisation (week 0) to end of treatment (week 52) | Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 (Percentage [%]) | From randomisation (week 0) to end of treatment (week 52) | Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Percentage (%) of body weight | MEAN |
| PRIMARY | Participants With Change to Normoglycemia | At week 52 | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Glycosylated Haemoglobin (HbA1c) | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Waist Circumference | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | centimeter (cm) | MEAN |
| SECONDARY | Change in Systolic Blood Pressure | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Ratio of triglycerides | GEOMETRIC_MEAN |
| SECONDARY | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Ratio of total cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Ratio of HDL cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Ratio of LDL cholesterol | GEOMETRIC_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group46
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 (Percentage [%]) | Semaglutide 2.4 mg | -14.4 | Standard Deviation 7.9 | Percentage (%) of body weight | |
| Change in Body Weight (Percentage [%]) | Placebo | -2.7 | Standard Deviation 4.3 | Percentage (%) of body weight | |
| Participants With Change to Normoglycemia | Semaglutide 2.4 mg | Normoglycemia | 103 | Participants | |
| Participants With Change to Normoglycemia | Placebo | Normoglycemia | 9 | Participants | |
| Participants With Change to Normoglycemia | Semaglutide 2.4 mg | Pre-diabetes | 23 | Participants | |
| Participants With Change to Normoglycemia | Placebo | Pre-diabetes | 53 | Participants | |
| Participants With Change to Normoglycemia | Semaglutide 2.4 mg | Type 2 diabetes | 1 | Participants | |
| Participants With Change to Normoglycemia | Placebo | Type 2 diabetes | 2 | Participants | |
| Change in Glycosylated Haemoglobin (HbA1c) | Semaglutide 2.4 mg | -0.4 | Standard Deviation 0.3 | Percentage of HbA1c | |
| Change in Glycosylated Haemoglobin (HbA1c) | Placebo | 0.1 | Standard Deviation 0.2 | Percentage of HbA1c |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 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 | 138 | |
| Overall Study | STARTED | Placebo | 69 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 138 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 69 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 138 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 69 | |
| Overall Study | COMPLETED | Semaglutide 2.4 mg | 128 | |
| Overall Study | COMPLETED | Placebo | 64 | |
| Overall Study | NOT COMPLETED | Semaglutide 2.4 mg | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events86
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 pain upper | Gastrointestinal disorders | Semaglutide 2.4 mg | 7 | 138 | 8 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 4 | 69 | 4 |
| other | COVID-19 | Infections and infestations | Semaglutide 2.4 mg | 48 | 138 | 55 |
| other | COVID-19 | Infections and infestations | Placebo | 21 | 69 | 21 |
| other | Constipation | Gastrointestinal disorders | Semaglutide 2.4 mg | 25 | 138 | 29 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 69 | 0 |
| other | Decreased appetite | Metabolism and nutrition disorders | Semaglutide 2.4 mg | 11 | 138 | 11 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 1 | 69 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Semaglutide 2.4 mg | 17 | 138 | 31 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 69 | 7 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 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 | 2 | 138 |
| Total, all-cause mortality | Placebo | 0 | 69 |
| Total, other adverse events | Semaglutide 2.4 mg | 93 | 138 |
| Total, other adverse events | Placebo | 30 | 69 |
| Total, serious adverse events | Semaglutide 2.4 mg | 12 | 138 |
| Total, serious adverse events | Placebo | 6 | 69 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39089293 | RESULT |
Source PubMed
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.
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GET https://conductscience.org/api/trials/v1/NCT05040971/results?page=2