Trial · NCT00796367
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
NCT00796367, Phase 3, Completed, VIVUS LLC; results first posted 2012-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787). Trials, record NCT00796367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
- NCT number
- NCT00796367
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 676 participants, actual
- Lead sponsor
- VIVUS LLC
- Conditions
- Obesity
- Interventions
- VI-0521, Placebo, VI-0521
- First posted
- 2008-11-24
- Last updated
- 2012-09-10
- Results first posted
- 2012-08-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Weight Change at End of Treatment, Week 108. | From baseline to end of treatment | |
| Primary | Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | Baseline to End of Treatment |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Weight Change at End of Treatment, Week 108. | From baseline to end of treatment | Intent-to-Treat Last observation carried forward (ITT-LOCF) | percent weight loss | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | Baseline to End of Treatment | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | percent participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Weight Change at End of Treatment, Week 108. | Placebo | -1.8 | Standard Error 0.55 | percent weight loss | |
| Percent Weight Change at End of Treatment, Week 108. | VI-0521 Mid | -9.32 | Standard Error 0.67 | percent weight loss | |
| Percent Weight Change at End of Treatment, Week 108. | VI-0521 Top | -10.5 | Standard Error 0.5 | percent weight loss | |
| Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | Placebo | 30 | percent participants | ||
| Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | VI-0521 Mid | 75.2 | percent participants | ||
| Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | VI-0521 Top | 79.3 | percent participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 227 | |
| Overall Study | STARTED | VI-0521 Mid | 154 | |
| Overall Study | STARTED | VI-0521 Top | 295 | |
| Overall Study | COMPLETED | Placebo | 197 | |
| Overall Study | COMPLETED | VI-0521 Mid | 129 | |
| Overall Study | COMPLETED | VI-0521 Top | 248 | |
| Overall Study | NOT COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | VI-0521 Mid | 25 | |
| Overall Study | NOT COMPLETED | VI-0521 Top | 47 |
Source ClinicalTrials.gov
Adverse events243
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 | upper respiratory tract infection | Infections and infestations | Placebo | 42 | 227 | |
| other | upper respiratory tract infection | Infections and infestations | VI-0521 Mid | 26 | 153 | |
| other | upper respiratory tract infection | Infections and infestations | VI-0521 Top | 45 | 295 | |
| other | nasopharyngitis | Infections and infestations | Placebo | 26 | 227 | |
| other | nasopharyngitis | Infections and infestations | VI-0521 Mid | 13 | 153 | |
| other | nasopharyngitis | Infections and infestations | VI-0521 Top | 26 | 295 | |
| other | sinusitis | Infections and infestations | Placebo | 18 | 227 | |
| other | sinusitis | Infections and infestations | VI-0521 Mid | 12 | 153 | |
| other | sinusitis | Infections and infestations | VI-0521 Top | 28 | 295 | |
| other | urinary tract infection | Infections and infestations | Placebo | 13 | 227 |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | VI-0521 Mid | ||
| Total, all-cause mortality | VI-0521 Top | ||
| Total, other adverse events | Placebo | 182 | 227 |
| Total, other adverse events | VI-0521 Mid | 111 | 153 |
| Total, other adverse events | VI-0521 Top | 234 | 295 |
| Total, serious adverse events | Placebo | 9 | 227 |
| Total, serious adverse events | VI-0521 Mid | 4 | 153 |
| Total, serious adverse events | VI-0521 Top | 13 | 295 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00796367
GET https://conductscience.org/api/trials/v1/NCT00796367/events?page=2