An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Launched by ZAFGEN, INC. · Feb 12, 2014
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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
About Zafgen, Inc.
Zafgen, Inc. is a biopharmaceutical company dedicated to developing innovative therapies for obesity and related metabolic disorders. Leveraging its proprietary drug discovery platform, Zafgen focuses on advancing novel treatments that target underlying biological mechanisms to achieve significant weight loss and improve metabolic health. Committed to scientific excellence and patient-centric solutions, the company aims to address the unmet medical needs of individuals struggling with obesity, ultimately enhancing their quality of life through effective, safe, and well-tolerated therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
St. Paul, Minnesota, United States
Sydney, New South Wales, Australia
Heidelberg Heights, Victoria, Australia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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