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

• Sponsor: Zafgen, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02063295
• Collaborator: (none)
• Enrollment: 14
• Locations: 4
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Over-weight; Hypothalamic Injury; Craniopharyngioma	Drug: ZGN-440 sterile diluent; Drug: ZGN-440 for injectable suspension	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: ZGN-440 sterile diluent Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.	Drug: ZGN-440 sterile diluent; ZGN-440 sterile diluent/placebo; Other Names: Placebo
Experimental: ZGN-440 for injectable suspension Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.	Drug: ZGN-440 for injectable suspension; Other Names: ZGN-440 Beloranib

Outcome Measures

Primary Outcome Measures

1. Change in body weight from baseline to the end of the randomized dosing period. [4 weeks]

Secondary Outcome Measures

1. Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period [4 weeks]

2. Change in hs-CRP from baseline to the end of the randomized dosing period. [4 weeks]

3. Change in hunger from baseline to the end of the randomized dosing period. [4 weeks]

4. Change in quality of life from baseline to the end of the randomized dosing period. [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospitals and Clinics of Minnesota	St. Paul	Minnesota	United States	55102
2	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
3	The Boden Institute	Sydney	New South Wales	Australia	2006
4	Austin Health, Metabolic Disorders Centre	Heidelberg Heights	Victoria	Australia	3081

Sponsors and Collaborators

• Zafgen, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zafgen, Inc.
• ClinicalTrials.gov Identifier: NCT02063295
• Other Study ID Numbers: ZAF-221
• First Posted: Feb 14, 2014
• Last Update Posted: Jul 18, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Zafgen, Inc.: Beloranib; ZGN-440; ZGN-440 for injectable suspension; ZGN-433
• Additional relevant MeSH terms: Craniopharyngioma; Adamantinoma; Overweight; Wounds and Injuries; CKD732

Study Results

No Results Posted as of Jul 18, 2016