Trial · NCT03548935
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
NCT03548935, 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. STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity. Trials, record NCT03548935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03548935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
- NCT number
- NCT03548935
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,961 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Overweight or Obesity
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2018-06-07
- Last updated
- 2021-11-19
- Other registries' IDs
- eudract:2017-003436-36
- Results first posted
- 2021-08-11
Source ClinicalTrials.gov
Registered outcomes42
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 observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (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 5 or More Percent Body Weight Reduction (Yes/no) | After week 68 | Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. 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 | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved weight loss more than or equal to (≥) 10% at 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 date of randomization (week 0) to date of last contact with trial site (week 75). |
| Secondary | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved more than or equal to (≥) 15% weight loss at 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 randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved more than or equal to (≥) 20% weight loss at 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 randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Waist Circumference (cm) | 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 randomization (week 0) to date of last contact with trial site (week 75). |
| Secondary | Change in Systolic Blood Pressure (mmHg) | 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 randomization (week 0) to date of last contact with trial site (week 75). |
| Secondary | Change in Short Form 36 (SF-36) | 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). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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 randomization (week 0) to last trial-related subject-site contact (week 75). |
| Secondary | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Baseline (week 0) to week 68 | IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. 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 randomization (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 randomization (week 0) to last trial-related subject-site contact (week 75). |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
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 point | MEAN |
| PRIMARY | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | After week 68 | 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 | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | Week 68 | FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | Week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | Week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Waist Circumference (cm) | 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 (mmHg) | 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) | Baseline (week 0) to week 68 | FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data. | Score on a scale | MEAN |
| SECONDARY | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Baseline (week 0) to week 68 | FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Score on a scale | MEAN |
| SECONDARY | Change in Body Weight (kg) | Baseline (week 0) to week 68 | FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Kilogram (kg) | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group134
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 | -15.6 | Standard Deviation 10.1 | Percentage point |
| Change in Body Weight (%) | Placebo | In-trial observation period | -2.8 | Standard Deviation 6.5 | Percentage point |
| Change in Body Weight (%) | Semaglutide 2.4 mg | On-treatment observation period | -16.9 | Standard Deviation 9.4 | Percentage point |
| Change in Body Weight (%) | Placebo | On-treatment observation period | -3.1 | Standard Deviation 6.4 | Percentage point |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Semaglutide 2.4 mg | In-trial observation period / Yes | 1047 | Participants | |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Placebo | In-trial observation period / Yes | 182 | Participants | |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Semaglutide 2.4 mg | In-trial observation period / No | 165 | Participants | |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Placebo | In-trial observation period / No | 395 | Participants | |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Semaglutide 2.4 mg | On-treatment observation period / Yes | 978 | Participants | |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | Placebo | On-treatment observation period / Yes | 165 | Participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 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 | 1,306 | |
| Overall Study | STARTED | Placebo | 655 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide 2.4 mg | 1,306 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 655 | |
| Overall Study | Safety Analysis Set (SAS) | Semaglutide 2.4 mg | 1,306 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 655 | |
| Overall Study | COMPLETED | Semaglutide 2.4 mg | 1,240 | |
| Overall Study | COMPLETED | Placebo | 609 | |
| Overall Study | NOT COMPLETED | Semaglutide 2.4 mg | 66 | |
| Overall Study | NOT COMPLETED | Placebo | 46 |
Source ClinicalTrials.gov
Adverse events344
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 | Sema 2.4 mg | 96 | 1,306 | 135 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 31 | 655 | 42 |
| other | Abdominal pain | Gastrointestinal disorders | Sema 2.4 mg | 127 | 1,306 | 172 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 36 | 655 | 41 |
| other | Abdominal pain upper | Gastrointestinal disorders | Sema 2.4 mg | 125 | 1,306 | 176 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 35 | 655 | 37 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Sema 2.4 mg | 81 | 1,306 | 92 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 43 | 655 | 47 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Sema 2.4 mg | 106 | 1,306 | 120 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 53 | 655 | 55 |
1 to 10 of 344Source ClinicalTrials.gov
See all 344 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sema 2.4 mg | 1 | 1,306 |
| Total, all-cause mortality | Placebo | 1 | 655 |
| Total, other adverse events | Sema 2.4 mg | 1,052 | 1,306 |
| Total, other adverse events | Placebo | 447 | 655 |
| Total, serious adverse events | Sema 2.4 mg | 128 | 1,306 |
| Total, serious adverse events | Placebo | 42 | 655 |
Source ClinicalTrials.gov
Papers12
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 |
|---|---|
| Sema 2.4 mg vs Placebo: deaths from any cause | Trial comparisons |
| Sema 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
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The record and each of its lists are JSON, twenty rows a page. No key.
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