Status:
COMPLETED
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
Lead Sponsor:
Zafgen, Inc.
Conditions:
Obesity
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
Detailed Description
This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing...
Eligibility Criteria
Inclusion
- Obese but otherwise healthy females
- Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
- BMI ≥ 30 and ≤ 45 kg/m2
- Stable body weight during the past 2 months
Exclusion
- Use of weight loss agents in the past month
- History of eating disorder
- History of type 1 or type 2 diabetes mellitus
- Current smokers
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01507077
Start Date
December 1 2011
End Date
March 1 2012
Last Update
July 18 2012
Active Locations (1)
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1
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia