Completed

VI-0521 for Glycemic Management in Obese Diabetic Adults

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Study Aim

This phase 2 study aims to evaluate the effectiveness of VI-0521 in improving glycemic management, specifically by observing changes in HbA1c levels over 28 weeks in obese adults with diabetes.

What is being tested

VI-0521

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2007
See protocol details

Summary

Principal SponsorVIVUS LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2007

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Official TitleA Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
NCT00486291
Principal SponsorVIVUS LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Informed consent
Type 2 Diabetes
BMI 27-42
Specified diet/exercise and/or diabetes medications
12 exclusion criteria prevent from participating
Pregnancy or breastfeeding
Alcohol abuse
Eating disorder
Excluded medications
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Phentermine 15mg/topiramate 100mg

Group II

Placebo
Matched placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

Research Site

Birmingham, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Los Angeles, United States
Suspended

Research Site

San Francisco, United States
Suspended

Research Site

Spring Valley, United States
Completed9 Study Centers