Clinical Trial: An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injur
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
Detailed Summary:
Sponsor: Zafgen, Inc.
Current Primary Outcome: Change in body weight from baseline to the end of the randomized dosing period. [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period [ Time Frame: 4 weeks ]
- Change in hs-CRP from baseline to the end of the randomized dosing period. [ Time Frame: 4 weeks ]
- Change in hunger from baseline to the end of the randomized dosing period. [ Time Frame: 4 weeks ]
- Change in quality of life from baseline to the end of the randomized dosing period. [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Zafgen, Inc.
Dates:
Date Received: February 12, 2014
Date Started: April 2014
Date Completion:
Last Updated: July 14, 2016
Last Verified: July 2016
