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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID: NCT00554216
Run by: VIVUS LLC
People needed: 1267
Starts: 2007-11-01
Expected to finish: 2009-05-01
Last updated by the study team: 2012-09-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body mass index (BMI) ≥ 35 kg/m2
Informed consent
70 years of age or less
Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
Fasting blood glucose level of ≤ 110 mg/dL

You may not qualify if…

Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
History of glaucoma or intraocular pressure
Pregnancy or breastfeeding
Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders
Cholelithiasis within past 6 months
Excluded medications
Type 2 diabetes
Previous bariatric surgery
History of bipolar disorder or psychosis

Where it is running

Research Site — San Diego, California, United States
Research — Ridgefield, Connecticut, United States
Research Site — Durham, North Carolina, United States
Research Site — Toledo, Ohio, United States
Research Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.