Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

Phase 3

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Drug: VI-0521

• Registration Number: NCT00553787
• Lead Sponsor: VIVUS LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-03
• Study First Submitted QC: 2007-11-03
• Study First Posted: 2007-11-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Results First Posted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2487

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 (<140/90 mmHg)

• Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)

• At lease one of the following metabolic criteria:

  • Fasting blood glucose level > 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VI-0521 Top	VI-0521	high dose experimental treatment
VI-0521 Mid	VI-0521	mid dose experimental treatment
Placebo	VI-0521	Placebo

Primary Outcome Measures

Name	Time	Method
Percent Weight Loss From Baseline to Week 56	Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	Baseline to 56 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Austin, Texas, United States