NCT00734201

Safety and Efficacy of Low Doses of V24343 in Obese Subjects

A Double-blind, Placebo-controlled, Parallel Group Study of the Effect of V24343 on Blood Pressure and Weight in Obese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vernalis (R&D) Ltd · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects. The primary variables, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring. The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose. Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343. Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	V24343	Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-08-14
• Last updated: 2011-07-25

Locations

1 site across 1 country: United Kingdom