ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss|
- Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]Measures of the safety and tolerability of ZGN-440 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
- Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
- Peak plasma concentration of ZGN-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
- Elimination half-life of ZGN-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: ZGN-440 sterile diluent||
Drug: ZGN-440 sterile diluent
Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Other Name: Beloranib for subcutaneous injection
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 potential. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
|Q-Pharm Clinics, Royal Brisbane and Women's Hospital|
|Brisbane, Queensland, Australia|
|Principal Investigator:||J K Marjason, MD||Q-Pharm Clinics, Royal Brisbane and Women's Hospital|