Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers
- Registration Number
- NCT01028261
- Lead Sponsor
- Zafgen, Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZGN-433 ZGN-433 - Normal Saline ZGN-433 -
- Primary Outcome Measures
Name Time Method 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. Approximately 2 months
- Secondary Outcome Measures
Name Time Method Weight Approximately 2 months
Trial Locations
- Locations (2)
Nucleus Network
🇦🇺Heidelberg, Victoria, Australia
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia