Clinical trial NCT02063295: An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Over-weight
Hypothalamic Injury
Craniopharyngioma
Keywords: Beloranib
ZGN-440
ZGN-440 for injectable suspension
ZGN-433
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in body weight from baseline to the end of the randomized dosing period.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
timeFrame: 4 weeks
measure: Change in hs-CRP from baseline to the end of the randomized dosing period.
timeFrame: 4 weeks
measure: Change in hunger from baseline to the end of the randomized dosing period.
timeFrame: 4 weeks
measure: Change in quality of life from baseline to the end of the randomized dosing period.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Sydney
country: Australia
facility: The Boden Institute
state: New South Wales
city: Heidelberg Heights
country: Australia
facility: Austin Health, Metabolic Disorders Centre
state: Victoria
Study officials:
References:
citation: 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.