An Efficacy, Safety, and Pharmacokinetics Study 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