Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02063295




Registration number
NCT02063295
Ethics application status
Date submitted
12/02/2014
Date registered
14/02/2014
Date last updated
18/07/2016

Titles & IDs
Public title
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Scientific 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
Secondary ID [1] 0 0
ZAF-221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Over-weight 0 0
Hypothalamic Injury 0 0
Craniopharyngioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Bone
Diet and Nutrition 0 0 0 0
Obesity
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZGN-440 sterile diluent
Treatment: Drugs - ZGN-440 for injectable suspension

Placebo Comparator: ZGN-440 sterile diluent - Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.

Experimental: ZGN-440 for injectable suspension - Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.


Treatment: Drugs: ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo

Treatment: Drugs: ZGN-440 for injectable suspension
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in body weight from baseline to the end of the randomized dosing period.
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Change in hs-CRP from baseline to the end of the randomized dosing period.
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Change in hunger from baseline to the end of the randomized dosing period.
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Change in quality of life from baseline to the end of the randomized dosing period.
Timepoint [4] 0 0
4 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Boden Institute - Sydney
Recruitment hospital [2] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zafgen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
beloranib in obese subjects with hypothalamic injury.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02063295
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02063295