Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

Vivus

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: VI-0521; Drug: Placebo matched phentermine/topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554216

OB-302

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Enrollment: 1,267 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥ 35 kg/m2
• Informed consent
• 70 years of age or less
• Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
• Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
• Fasting blood glucose level of ≤ 110 mg/dL

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
• History of glaucoma or intraocular pressure
• Pregnancy or breastfeeding
• 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 2 diabetes
• Previous bariatric surgery
• History of bipolar disorder or psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,267 participants in 3 patient groups, including a placebo group

VI-0521 Low

Experimental group

Description:

VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)

Treatment:

Drug: VI-0521

Drug: VI-0521

VI-0521 Top

Experimental group

Description:

Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.

Treatment:

Drug: VI-0521

Drug: VI-0521

Placebo

Placebo Comparator group

Description:

Placebo to match

Treatment:

Drug: Placebo matched phentermine/topiramate