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

Official Title

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

Conditions

•  Obesity

Study Type

Interventional

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Further Details

Primary Outcome Measures:

• Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
  [ Time Frame: Approximately 2 months ]
  [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Weight
  [ Time Frame: Approximately 2 months ]
  [ Designated as safety issue: No ]

 

Arms	Assigned Interventions
ZGN-433: Experimental	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.
Normal Saline: Placebo Comparator	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.

Detailed Description:

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 Start

December 2009 – January 2011

Eligibility & Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Genders Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Total Enrolment

40

Contact Details

Australia, Queensland

Q-Pharm Clinics, Royal Brisbane and Women’s Hospital
Brisbane, Queensland, Australia, 4006
Contact: Gabrielle Baldauf
+61 7 3845 3661  
volunteers@qpharm.com.au     

Contact: Laurie Kear
+61 7 3845 3622
l.kear@qpharm.com.au

Principal Investigator: J K Marjason, MD

Australia, Victoria

Nucleus Network
Heidelberg, Victoria, Australia, 3084
Contact: Jenny Smyrnis    
+61 3 9496 6726
 j.smyrnis@nucleusnetwork.com.au  

Contact: Suzy Cake    
+61 3 9496 6741    
s.cake@nucleusnetwork.com.au   

Principal Investigator: Joseph Proietto, MD