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

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

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 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.

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)