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

Vivus

Status and phase: Completed; Phase 3

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: VI-0521

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553787

OB-303

Details and patient eligibility

About

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.

Enrollment: 2,487 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,487 participants in 3 patient groups, including a placebo group

VI-0521 Top

Experimental group

Description:

high dose experimental treatment

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521

VI-0521 Mid

Experimental group

Description:

mid dose experimental treatment

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521