A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers
Overview
- Phase
- Phase 1
- Intervention
- ZGN-433
- Conditions
- Obesity
- Sponsor
- Zafgen, Inc.
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
ZGN-433
Intervention: ZGN-433
Normal Saline
Intervention: ZGN-433
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Weight(Approximately 2 months)