An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
NCT ID: NCT02063295
Last Updated: 2016-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2014-04-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ZGN-440 sterile diluent
Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
ZGN-440 for injectable suspension
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
ZGN-440 for injectable suspension
Interventions
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ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
ZGN-440 for injectable suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Zafgen, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18.
Other Identifiers
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ZAF-221
Identifier Type: -
Identifier Source: org_study_id
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