An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

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 Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

Inclusion Criteria:

• Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
• Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
• Stable body weight for at least 3 months
• Type 2 diabetes mellitus is allowed

Exclusion Criteria:

• Males taking gonadotropin replacement therapy (LH/FSH)
• Subjects who are planning any fertility treatment within 6 months of study participation
• Use of weight loss agents, including herbal medications, in the past 3 months
• Current or anticipated chronic use of narcotics or opiates
• History of severe psychiatric disorders
• Type 1 diabetes mellitus
• Metabolic disorders or genetic disorders linked to obesity
• History of any bariatric surgery
• Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
• Blood loss or donation >500 mL within the past 3 months
• Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation