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

Phase 2

Completed

• Conditions: Obesity; Craniopharyngioma; Over-weight; Hypothalamic Injury
• Interventions: Drug: ZGN-440 for injectable suspension; Drug: ZGN-440 sterile diluent

• Registration Number: NCT02063295
• Lead Sponsor: Zafgen, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Start: 2014-04
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-14
• Disposition First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Disposition First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZGN-440 for injectable suspension	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 sterile diluent	ZGN-440 sterile diluent	Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline to the end of the randomized dosing period.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period	4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.	4 weeks
Change in hunger from baseline to the end of the randomized dosing period.	4 weeks
Change in quality of life from baseline to the end of the randomized dosing period.	4 weeks

Trial Locations

Locations (4)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 St. Paul, Minnesota, United States

Austin Health, Metabolic Disorders Centre; 🇦🇺 Heidelberg Heights, Victoria, Australia

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Boden Institute; 🇦🇺 Sydney, New South Wales, Australia