NCT03254368

Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Zafgen, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

Detailed description

Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).

Conditions

• Type 2 Diabetes Mellitus
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	ZGN-1061	ZGN-1061 is a methionine aminopeptidase 2 inhibitor
DRUG	Placebo	Placebo has the same excipients and appearance as ZGN-1061

Timeline

• Start date: 2017-09-12
• Primary completion: 2018-11-12
• Completion: 2019-02-22
• First posted: 2017-08-18
• Last updated: 2019-05-24

Locations

23 sites across 2 countries: Australia, New Zealand