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

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

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.

Inclusion Criteria:

• Obese but otherwise healthy females
• Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
• BMI ≥ 30 and ≤ 50 kg/m2
• Stable body weight during the past month

Exclusion Criteria:

• Use of weight loss agents in the past month
• History of eating disorder
• History of gastric bypass surgery
• Current smokers