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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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