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A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)

Information source: VIVUS, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: VI-0521 (Drug); Placebo (Drug); VI-0521 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: VIVUS, Inc.

Official(s) and/or principal investigator(s):
Craig Peterson, Study Director, Affiliation: VIVUS, Inc.


The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).

Clinical Details

Official title: A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Percent Weight Change at End of Treatment, Week 108.

Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria: To be eligible for enrollment into this study, subjects must meet all of the following criteria:

- Completion of study OB-303 (NCT00553787) on treatment and compliance with all

protocol requirements

- Written informed consent

- Female subjects of childbearing potential must be using adequate contraception,

defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L

- Willingness and ability to comply with scheduled visits, treatment plan, laboratory

tests, and other study procedures. Exclusion Criteria: Subjects will not be included in the study if they meet any of the following:

- Body mass index ≤22 kg/m2 at the completion of study OB-303

- Off study medication at completion of study OB-303 (NCT00553787) for longer than 4

weeks continuously due to an event-driven holiday, or off study medication with no plans to restart

- Development of any condition during study OB-303 (NCT00553787) that, in the opinion

of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results

- Participation in a formal weight loss program (including: Weight Watchers and

related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).

Locations and Contacts

Additional Information

VIVUS company website

Starting date: December 2008
Last updated: September 5, 2012

Page last updated: August 23, 2015

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