An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Weight Reduction, Glycemic Control, Safety, and Tolerability
Enrollment: 152
Study Start Date: December 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: ZGN-440 Injectable Suspension (1.2mg)
- Experimental: ZGN-440 Injectable Suspension (1.8mg)
- Placebo Comparator: Placebo