Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects

Obesity Clinical Trial

Official title: A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects

Status Completed

Clinical Trial Summary

The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:

• Days 1-3: PHEN/TPM 3.75 mg /23 mg

• Days 4-6: PHEN/TPM 7.5 mg /46 mg

• Days 7-9: PHEN/TPM 11.25 mg /69 mg

• Days 10-28: PHEN/TPM 15 mg /92 mg

A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.

The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.

Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up). ;

Related Conditions & MeSH terms

• Obesity
• Overweight

• NCT number: NCT02229214
• Study type: Interventional
• Source: VIVUS, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Completion date: November 2014