Back to resultsAn Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Primary Purpose
Obesity, Over-weight, Hypothalamic Injury
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZGN-440 sterile diluent
ZGN-440 for injectable suspension
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
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
Sites / Locations
- Children's Hospitals and Clinics of Minnesota
- Vanderbilt University Medical Center
- The Boden Institute
- Austin Health, Metabolic Disorders Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
ZGN-440 sterile diluent
ZGN-440 for injectable suspension
Arm Description
Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
Outcomes
Primary Outcome Measures
Change in body weight from baseline to the end of the randomized dosing period.
Secondary Outcome Measures
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Change in hs-CRP from baseline to the end of the randomized dosing period.
Change in hunger from baseline to the end of the randomized dosing period.
Change in quality of life from baseline to the end of the randomized dosing period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02063295
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zafgen, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Over-weight, Hypothalamic Injury, Craniopharyngioma
Keywords
Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZGN-440 sterile diluent
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
Arm Title
ZGN-440 for injectable suspension
Arm Type
Experimental
Arm Description
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
ZGN-440 sterile diluent
Other Intervention Name(s)
Placebo
Intervention Description
ZGN-440 sterile diluent/placebo
Intervention Type
Drug
Intervention Name(s)
ZGN-440 for injectable suspension
Other Intervention Name(s)
ZGN-440, Beloranib
Primary Outcome Measure Information:
Title
Change in body weight from baseline to the end of the randomized dosing period.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Time Frame
4 weeks
Title
Change in hs-CRP from baseline to the end of the randomized dosing period.
Time Frame
4 weeks
Title
Change in hunger from baseline to the end of the randomized dosing period.
Time Frame
4 weeks
Title
Change in quality of life from baseline to the end of the randomized dosing period.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Boden Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Facility Name
Austin Health, Metabolic Disorders Centre
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
28261955
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.
Results Reference
derived
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An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
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