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

A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: VI-0521; Drug: VI-0521; Drug: VI-0521; Drug: topiramate; Drug: topiramate; Drug: phentermine; Drug: phentermine

• Study Type: Interventional
• Enrollment (Actual): 756
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: VI-0521; phentermine 15 mg and topiramate 92 mg, po once daily; Drug: VI-0521; phentermine 7.5 mg and topiramate 46 mg, po once daily; Drug: VI-0521; placebo, po once daily
Experimental: VI-0521 Top; VI-0521; high dose phentermine/topiramate	Drug: VI-0521; phentermine 15 mg and topiramate 92 mg, po once daily; Drug: VI-0521; phentermine 7.5 mg and topiramate 46 mg, po once daily; Drug: VI-0521; placebo, po once daily
Experimental: VI-0521 Mid; VI-0521; mid dose phentermine/topiramate	Drug: VI-0521; phentermine 15 mg and topiramate 92 mg, po once daily; Drug: VI-0521; phentermine 7.5 mg and topiramate 46 mg, po once daily; Drug: VI-0521; placebo, po once daily
Active Comparator: TPM 46; mid dose topiramate	Drug: topiramate; topiramate 46 mg, po once daily; Drug: topiramate; topiramate 92 mg, po once daily
Active Comparator: TPM 92; high dose topiramate	Drug: topiramate; topiramate 46 mg, po once daily; Drug: topiramate; topiramate 92 mg, po once daily
Active Comparator: PHEN 7.5; mid dose phentermine	Drug: phentermine; phentermine 7.5 mg, po once daily; Drug: phentermine; phentermine 15 mg, po once daily
Active Comparator: PHEN 15; high dose phentermine	Drug: phentermine; phentermine 7.5 mg, po once daily; Drug: phentermine; phentermine 15 mg, po once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Weight Loss From Baseline to Week 28	Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)	baseline to 28 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF		baseline to 28 weeks

Collaborators and Investigators

• Sponsor: VIVUS LLC
• Collaborators: Medpace, Inc.
• Investigators: Study Chair: Kishore Gadde, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 21, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Topiramate; Phentermine
• Other Study ID Numbers: OB-301