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

Obesity Clinical Trial

Official title:

A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553787
• Other study ID #: OB-303
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2007
• Last updated: September 5, 2012
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2487
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
• VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
• VI-0521
placebo

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Durham	North Carolina
United States	Research Site	New York	New York
United States	Research Site	Ridgefield	Connecticut
United States	Research Site	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
VIVUS, Inc.	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Weight Loss From Baseline to Week 56		Baseline to 56 weeks	No
Primary	Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF		Baseline to 56 weeks	No