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NCT00554216 · ClinicalTrials.gov registry record · Phase 3

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

A Phase 3 study of Obesity, sponsored by VIVUS.

Completed
Registry status
Phase 3
Development phase
1,267
Enrollment target
5
Study locations

NCT00554216: Completed Phase 3 study of Obesity, sponsored by VIVUS.

NCT00554216 is a Phase 3 study of Obesity that has completed, run by VIVUS. The registered enrollment target is 1,267 participants, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (55% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00554216, a Phase 3 study of Obesity, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 3
Development phase
1,267 participants
Enrollment target
5
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Conditions Studied

Interventions

  • DRUG VI-0521
  • DRUG Placebo matched phentermine/topiramate

Study Locations (5)

California

  • Research Site - San Diego

Connecticut

  • Research - Ridgefield

North Carolina

  • Research Site - Durham

Ohio

  • Research Site - Toledo

Texas

  • Research Site - Austin

Trial Details

FieldValue
Enrollment Target 1,267 participants
Start Date 2007-11
Est. Completion 2009-05
Phase Phase 3
VIVUS

35 total trials

What the finished NCT00554216 record still lists

NCT00554216 is an interventional study that assigns participants to a tested intervention. Its 1,267 participants enrollment target places it among the larger protocols in the corpus, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (55% higher).

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which VI-0521 is the first listed.

NCT00554216 lists 5 locations in 5 states (California, Connecticut, North Carolina).

Frequently Asked Questions

What is clinical trial NCT00554216 about?

NCT00554216 is a clinical study titled "Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults". The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

What is the current status of trial NCT00554216?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,267 participants. The study started on 2007-11. Estimated completion is 2009-05.

What conditions does trial NCT00554216 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT00554216?

The interventions under investigation include: VI-0521 (DRUG), Placebo matched phentermine/topiramate (DRUG).

Who is sponsoring clinical trial NCT00554216?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00554216 being conducted?

This trial has 5 study locations across California, Connecticut, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00554216's enrollment target sits among peer trials

1,267 63rd of 1053 higher than 991 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00554216, the US trial registry maintained by the National Library of Medicine. NCT00554216 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.