Trial · NCT00553787

Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

NCT00553787, Phase 3, Completed, VIVUS LLC; results first posted 2012-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions. Trials, record NCT00553787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00553787

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
NCT number: NCT00553787
Status: Completed
Phases: Phase 3
Enrollment: 2,487 participants, actual
Lead sponsor: VIVUS LLC
Conditions: Obesity, Type 2 Diabetes
Interventions: VI-0521, VI-0521, VI-0521
First posted: 2007-11-06
Last updated: 2012-09-10
Results first posted: 2012-09-06

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 56	Baseline to 56 weeks
Primary	Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	Baseline to 56 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 56	Baseline to 56 weeks	intent-to-treat last-observation-carried-forward (ITT-LOCF)	percent weight loss	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	Baseline to 56 weeks	intent-to-treat last-observation-carried-forward (ITT-LOCF)	percentage of 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	Value	Spread	Units
Percent Weight Loss From Baseline to Week 56	Placebo	1.24	Standard Error 0.277	percent weight loss
Percent Weight Loss From Baseline to Week 56	VI-0521 Mid	7.81	Standard Error 0.365	percent weight loss
Percent Weight Loss From Baseline to Week 56	VI-0521 Top	9.84	Standard Error 0.275	percent weight loss
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	Placebo	20.8		percentage of participants
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	VI-0521 Mid	62.1		percentage of participants
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	VI-0521 Top	70		percentage of participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	994
Overall Study	STARTED	VI-0521 Mid	498
Overall Study	STARTED	VI-0521 Top	995
Overall Study	COMPLETED	Placebo	616
Overall Study	COMPLETED	VI-0521 Mid	374
Overall Study	COMPLETED	VI-0521 Top	733
Overall Study	NOT COMPLETED	Placebo	378
Overall Study	NOT COMPLETED	VI-0521 Mid	124
Overall Study	NOT COMPLETED	VI-0521 Top	262

Source ClinicalTrials.gov

Adverse events297

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
other	Upper Respiratory Tract Infection	Infections and infestations	Placebo	128	993
other	Upper Respiratory Tract Infection	Infections and infestations	VI-0521 Mid	61	498
other	Upper Respiratory Tract Infection	Infections and infestations	VI-0521 Top	133	994
other	Nasopharyngitis	Infections and infestations	Placebo	86	993
other	Nasopharyngitis	Infections and infestations	VI-0521 Mid	53	498
other	Nasopharyngitis	Infections and infestations	VI-0521 Top	98	994
other	sinusitis	Infections and infestations	Placebo	67	993
other	sinusitis	Infections and infestations	VI-0521 Mid	34	498
other	sinusitis	Infections and infestations	VI-0521 Top	85	994
other	bronchitis	Infections and infestations	Placebo	43	993

1 to 10 of 297Source ClinicalTrials.gov

See all 297 adverse events

Adverse 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	761	993
Total, other adverse events	VI-0521 Mid	424	498
Total, other adverse events	VI-0521 Top	874	994
Total, serious adverse events	Placebo	40	993
Total, serious adverse events	VI-0521 Mid	15	498
Total, serious adverse events	VI-0521 Top	50	994

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21481449	DERIVED	PubMed
25249652	DERIVED	PubMed
28455281	DERIVED	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00553787

GET https://conductscience.org/api/trials/v1/NCT00553787/events?page=2

API reference For AI assistants