An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity, Over-weight, Hypothalamic Injury, Craniopharyngioma
In brief
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
Key facts
- Study ID
- NCT02063295
- Run by
- Zafgen, Inc.
- People needed
- 14
- Starts
- 2014-04-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-07-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- The Boden Institute — Sydney, New South Wales, Australia
- Austin Health, Metabolic Disorders Centre — Heidelberg Heights, Victoria, Australia
Full record on ClinicalTrials.gov
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