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

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zafgen, Inc.
• Treatments: CKD732

Criteria

Inclusion Criteria:

• Obese with BMI ≥30 kg/m2

• Type 2 diabetes mellitus

• HbA1c of 7-11%

• Fasting glucose <15.5 mmol/L

• Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents

• Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive

Exclusion Criteria:

• Current or recent use of insulin

• Severe hypoglycemia within the prior 6 months

• Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)