NCT02229214

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Qsymia
DRUG	Placebo

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-09-01
• Last updated: 2017-11-07
• Results posted: 2016-02-09

Locations

1 site across 1 country: United States