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

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers

The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Inclusion Criteria:

• Obese, otherwise healthy females
• Post menopausal or infertile
• Weight ≥ 50 kg
• BMI ≥ 32 and ≤ 45 kg/m2

Exclusion Criteria:

• Use of weight loss agents in the past month
• History of eating disorder
• History of diabetes or other endocrine disorder
• History of gastric bypass
• Current smokers
• Unstable body weight during the past 3 months