Trial | NCT01028261  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    beloranib ...

  • Study Participants

    31
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.
Study Started
Dec 31
2009
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Last Update
Jan 11
2012
Estimate

Drug ZGN-433

Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.

  • Other names: Beloranib hemioxalate

ZGN-433 Experimental

Normal Saline Placebo Comparator

Criteria 

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
No Results Posted