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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063295
• Other study ID #: ZAF-221
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: July 14, 2016
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2016
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniopharyngioma
• Hypothalamic Injury
• Obesity
• Over-weight
• Overweight
• Wounds and Injuries

Intervention

Drug:
• ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
• ZGN-440 for injectable suspension

Locations

Country	Name	City	State
Australia	Austin Health, Metabolic Disorders Centre	Heidelberg Heights	Victoria
Australia	The Boden Institute	Sydney	New South Wales
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Children's Hospitals and Clinics of Minnesota	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline to the end of the randomized dosing period.		4 weeks	No
Secondary	Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period		4 weeks	No
Secondary	Change in hs-CRP from baseline to the end of the randomized dosing period.		4 weeks	No
Secondary	Change in hunger from baseline to the end of the randomized dosing period.		4 weeks	No
Secondary	Change in quality of life from baseline to the end of the randomized dosing period.		4 weeks	No