A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

Vivus

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: phentermine; Drug: VI-0521; Drug: topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563368

OB-301

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Enrollment: 756 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
• Informed Consent
• Females of child-bearing potential must be using adequate contraception

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
• Glaucoma or elevated intraocular pressure
• Pregnancy or breastfeeding
• Drug or Alcohol abuse
• Smoking cessation within previous 3 months or plans to quit smoking during study
• Eating disorders within past year
• Cholelithiasis within past 6 months
• Type 2 diabetes
• Previous bariatric surgery
• Bipolar disorder or psychosis
• Steroid hormone therapy not stable for 3 months
• Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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756 participants in 7 patient groups, including a placebo group

VI-0521 Top

Experimental group

Description:

VI-0521; high dose phentermine/topiramate

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521

VI-0521 Mid

Experimental group

Description:

VI-0521; mid dose phentermine/topiramate

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521

TPM 46

Active Comparator group

Description:

mid dose topiramate

Treatment:

Drug: topiramate

Drug: topiramate

TPM 92

Active Comparator group

Description:

high dose topiramate

Treatment:

Drug: topiramate

Drug: topiramate

PHEN 7.5

Active Comparator group

Description:

mid dose phentermine

Treatment:

Drug: phentermine

Drug: phentermine

PHEN 15

Active Comparator group

Description:

high dose phentermine

Treatment:

Drug: phentermine

Drug: phentermine

Placebo

Placebo Comparator group

Treatment:

Drug: VI-0521

Drug: VI-0521

Drug: VI-0521