Trial · NCT03611582
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
NCT03611582, Phase 3, Completed, Novo Nordisk A/S; results first posted 2021-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program. Trials, record NCT03611582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03611582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
- NCT number
- NCT03611582
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 611 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Overweight, Obesity
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2018-08-02
- Last updated
- 2021-11-11
- Results first posted
- 2021-07-09
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight (%) | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment 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: 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). |
| Primary | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | After 68 weeks | Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. 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 randomization (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. |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% | After 68 weeks | Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% | After 68 weeks | Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% | After 68 weeks | Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Waist Circumference | Baseline (week 0) to week 68 | Change in waist circumference from baseline (week 0) 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 randomisation (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Systolic Blood Pressure | Baseline (week 0) to week 68 | Change in systolic blood pressure from baseline (week 0) 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 randomisation (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Short Form-36 (SF-36) - Physical Functioning Score | Baseline (week 0) 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 0 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 randomisation (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Body Weight (Kg) | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) 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 randomisation (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Body Mass Index | Baseline (week 0) to week 68 | Change in body mass index from baseline (week 0) 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 randomisation (week 0) to last trial-related subject-site contact (week 75). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
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 (%) | Baseline (week 0) to week 68 | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data. | Percentage | MEAN |
| PRIMARY | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | After 68 weeks | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% | After 68 weeks | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% | After 68 weeks | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% | After 68 weeks | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 Analyzed' = participants with available data. | Centimeter (cm) | MEAN |
| SECONDARY | Change in Systolic Blood Pressure | Baseline (week 0) 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 Short Form-36 (SF-36) - Physical Functioning Score | Baseline (week 0) to week 68 | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data. | Score on a scale | MEAN |
| SECONDARY | Change in Body Weight (Kg) | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Kilogram (kg) | MEAN |
| SECONDARY | Change in Body Mass Index | Baseline (week 0) to week 68 | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data. | Kilogram per square meter (kg/sqm) | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group100
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 | In-trial observation period | -16.5 | Standard Deviation 10.1 | Percentage |
| Change in Body Weight (%) | Placebo | In-trial observation period | -5.8 | Standard Deviation 7.7 | Percentage |
| Change in Body Weight (%) | Semaglutide 2.4 mg | On-treatment observation period | -17.6 | Standard Deviation 9.6 | Percentage |
| Change in Body Weight (%) | Placebo | On-treatment observation period | -6.1 | Standard Deviation 7.6 | Percentage |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Semaglutide 2.4 mg | In-trial observation period / Yes | 323 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Placebo | In-trial observation period / Yes | 90 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Semaglutide 2.4 mg | In-trial observation period / No | 50 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Placebo | In-trial observation period / No | 99 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Semaglutide 2.4 mg | On-treatment observation period / Yes | 300 | Participants | |
| Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% | Placebo | On-treatment observation period / Yes | 82 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 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 | 407 | |
| Overall Study | STARTED | Placebo | 204 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 407 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 204 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 407 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 204 | |
| Overall Study | COMPLETED | Semaglutide 2.4 mg | 339 | |
| Overall Study | COMPLETED | Placebo | 166 | |
| Overall Study | NOT COMPLETED | Semaglutide 2.4 mg | 68 | |
| Overall Study | NOT COMPLETED | Placebo | 38 |
Source ClinicalTrials.gov
Adverse events146
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 2.4 mg | 41 | 407 | 55 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 20 | 204 | 28 |
| other | Abdominal pain | Gastrointestinal disorders | Semaglutide 2.4 mg | 53 | 407 | 75 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 10 | 204 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide 2.4 mg | 33 | 407 | 45 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 5 | 204 | 5 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Semaglutide 2.4 mg | 39 | 407 | 54 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 19 | 204 | 23 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Semaglutide 2.4 mg | 53 | 407 | 67 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 22 | 204 | 24 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 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 | 0 | 407 |
| Total, all-cause mortality | Placebo | 0 | 204 |
| Total, other adverse events | Semaglutide 2.4 mg | 379 | 407 |
| Total, other adverse events | Placebo | 177 | 204 |
| Total, serious adverse events | Semaglutide 2.4 mg | 37 | 407 |
| Total, serious adverse events | Placebo | 6 | 204 |
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.
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