Phase 3 Completed N=756 Randomized Quadruple-blind Treatment

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

Obesity

Source: ClinicalTrials.gov NCT00563368 ↗

Enrolled (actual)

756

Serious AEs

0.9%

Results posted

Sep 2012

Primary outcomePrimary: Percent Weight Loss From Baseline to Week 28 — 1.7; 5.5; 5.1; 8.5 percent weight loss — p=0.0009

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Weight Loss From Baseline to Week 28	1.7; 5.5; 5.1; 8.5; 6.1; 6.4	0.0009 sig
PRIMARY Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF	15.5; 43.3; 39.2; 62.1; 46.2; 48.6	0.0140 sig

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00563368). 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. Informational only — not medical advice.