A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS, Inc.
• Collaborator: Medpace, Inc.
• Treatments: Phentermine; Topiramate

Criteria

Inclusion Criteria:

• 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

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

• 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