Phase 3
N=1,267
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00554216 ↗Enrolled (actual)
1,267
Serious AEs
2.6%
Results posted
Sep 2012
Primary outcome: Primary: Percent Weight Loss From Baseline to Week 56 — 1.55; 5.10; 10.92 percent weight loss — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VI-0521 (Drug); Placebo matched phentermine/topiramate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VIVUS LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Loss From Baseline to Week 56 |
1.55; 5.10; 10.92 | <0.0001 sig |
| PRIMARY Percentage of Subjects With at Least 5% Weight Loss at Week 56 |
17.3; 44.9; 66.7 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00554216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.