Phase 3
Completed N=2,487
Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Source: ClinicalTrials.gov NCT00553787 ↗Enrolled (actual)
2,487
Serious AEs
4.2%
Results posted
Sep 2012
Primary outcomePrimary: Percent Weight Loss From Baseline to Week 56 — 1.24; 7.81; 9.84 percent weight loss — p=<0.0001
Summary
The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Loss From Baseline to Week 56 |
1.24; 7.81; 9.84 | <0.0001 sig |
| PRIMARY Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF |
20.8; 62.1; 70 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
- 70 years of age or less
- Have 2 or more of the following obesity-related co-morbid conditions:
- Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
- Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
- Requirement for 2 or more medications to achieve control ( 100 mg/dL
- Glucose level > 140 mg/dL
- Diagnosis of type 2 diabetes
- Waist circumference ≥ 102 cm for men or ≥88 cm for women
Exclusion Criteria
- Stroke/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 intraocular pressure
- Pregnancy or breastfeeding
- Drug or 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 1 diabetes or use of any antidiabetic medication other than metformin
- Previous bariatric surgery
- Bipolar disorder or psychosis
- Steroid hormone therapy
- Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
- Creatinine clearance < 60 mL/minute
Data sourced from ClinicalTrials.gov (NCT00553787). 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.