A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Completed · Phase 3 · Has a placebo group
Conditions studied: Obesity
In brief
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.
Key facts
- Study ID
- NCT00563368
- Run by
- VIVUS LLC
- People needed
- 756
- Starts
- 2007-12-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2015-03-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
- Informed Consent
- Females of child-bearing potential must be using adequate contraception
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
- Glaucoma or elevated intraocular pressure
- Pregnancy or breastfeeding
- Drug or Alcohol abuse
- Smoking cessation within previous 3 months or plans to quit smoking during study
- Eating disorders within past year
- Cholelithiasis within past 6 months
- Type 2 diabetes
- Previous bariatric surgery
- Bipolar disorder or psychosis
- Steroid hormone therapy not stable for 3 months
- Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Where it is running
- Research Site — Durham, North Carolina, United States
- Research Site — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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