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COMPLETED Phase 3

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

NCT00554216 · View on ClinicalTrials.gov ↗

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

Sponsor

VIVUS

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00554216

The ClinicalTrials.gov registry entry for NCT00554216 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00554216 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Connecticut, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00554216?

The interventions under investigation include: VI-0521 (DRUG), Placebo matched phentermine/topiramate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00554216?

This trial is sponsored by VIVUS, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial