Trial · NCT00563368
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
NCT00563368, Phase 3, Completed, VIVUS LLC; results first posted 2012-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults. Trials, record NCT00563368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00563368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
- NCT number
- NCT00563368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 756 participants, actual
- Lead sponsor
- VIVUS LLC
- Conditions
- Obesity
- Interventions
- VI-0521, VI-0521, topiramate, topiramate, phentermine, phentermine, VI-0521
- First posted
- 2007-11-26
- Last updated
- 2015-03-30
- Results first posted
- 2012-09-03
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 Loss From Baseline to Week 28 | baseline to 28 weeks | Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF) |
| Primary | Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF | baseline to 28 weeks |
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 Loss From Baseline to Week 28 | baseline to 28 weeks | 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 Week 28 With LOCF | baseline to 28 weeks | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Weight Loss From Baseline to Week 28 | Placebo | 1.7 | Standard Error 0.61 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | PHEN 7.5 mg | 5.5 | Standard Error 0.61 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | TPM 46 mg | 5.1 | Standard Error 0.61 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | VI-0521 Mid | 8.5 | Standard Error 0.62 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | PHEN 15 mg | 6.1 | Standard Error 0.61 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | TPM 92 mg | 6.4 | Standard Error 0.62 | percent weight loss | |
| Percent Weight Loss From Baseline to Week 28 | VI-0521 Top | 9.2 | Standard Error 0.61 | percent weight loss | |
| Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF | Placebo | 15.5 | percentage of participants | ||
| Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF | PHEN 7.5 mg | 43.3 | percentage of participants | ||
| Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF | TPM 46 mg | 39.2 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 109 | |
| Overall Study | STARTED | PHEN 7.5 mg | 109 | |
| Overall Study | STARTED | TPM 46 mg | 108 | |
| Overall Study | STARTED | VI-0521 Mid | 107 | |
| Overall Study | STARTED | PHEN 15 mg | 108 | |
| Overall Study | STARTED | TPM 92 mg | 107 | |
| Overall Study | STARTED | VI-0521 Top | 108 | |
| Overall Study | COMPLETED | Placebo | 74 | |
| Overall Study | COMPLETED | PHEN 7.5 mg | 79 | |
| Overall Study | COMPLETED | TPM 46 mg | 78 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events203
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 | Bronchitis | Infections and infestations | Placebo | 3 | 109 | |
| other | Bronchitis | Infections and infestations | PHEN 7.5 mg | 2 | 109 | |
| other | Bronchitis | Infections and infestations | TPM 46 mg | 2 | 106 | |
| other | Bronchitis | Infections and infestations | VI-0521 Mid | 6 | 106 | |
| other | Bronchitis | Infections and infestations | PHEN 15 mg | 3 | 108 | |
| other | Bronchitis | Infections and infestations | TPM 92 mg | 2 | 107 | |
| other | Bronchitis | Infections and infestations | VI-0521 Top | 5 | 108 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 12 | 109 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | PHEN 7.5 mg | 9 | 109 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | TPM 46 mg | 13 | 106 |
1 to 10 of 203Source ClinicalTrials.gov
See all 203 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PHEN 7.5 mg | ||
| Total, all-cause mortality | TPM 46 mg | ||
| Total, all-cause mortality | VI-0521 Mid | ||
| Total, all-cause mortality | PHEN 15 mg | ||
| Total, all-cause mortality | TPM 92 mg | ||
| Total, all-cause mortality | VI-0521 Top | ||
| Total, other adverse events | Placebo | 87 | 109 |
| Total, other adverse events | PHEN 7.5 mg | 85 | 109 |
| Total, other adverse events | TPM 46 mg | 90 | 106 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00563368
GET https://conductscience.org/api/trials/v1/NCT00563368/flow?page=2