NCT01372761

Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Zafgen, Inc. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Detailed description

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	ZGN-433	Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
DRUG	Normal Saline	Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-06-14
• Last updated: 2011-12-30

Locations

1 site across 1 country: Australia