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

Status:	Completed
Conditions:	Obesity Weight Loss, Obesity Weight Loss, Hospital, Neurology
Therapuetic Areas:	Endocrinology, Neurology, Other
Healthy:	No
Age Range:	18 - 65
Updated:	11/8/2014
Start Date:	April 2014
End Date:	December 2014

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

We found this trial at

sites

Childrens Hospitals And Clinics Of Minnesota

St. Paul, Minnesota 55102

from

St. Paul, MN