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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01507077




Registration number
NCT01507077
Ethics application status
Date submitted
5/01/2012
Date registered
10/01/2012
Date last updated
18/07/2012

Titles & IDs
Public title
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
Scientific title
ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss
Secondary ID [1] 0 0
ZAF-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

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

Placebo Comparator: ZGN-440 sterile diluent -

Experimental: ZGN-440 -


Treatment: Drugs: ZGN-440
Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Treatment: Drugs: ZGN-440 sterile diluent
Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.
Timepoint [1] 0 0
Approximately 4 weeks
Secondary outcome [1] 0 0
Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
Timepoint [1] 0 0
Approximately 4 weeks
Secondary outcome [2] 0 0
Peak plasma concentration of ZGN-440 to assess relationship to weight loss.
Timepoint [2] 0 0
Approximately 4 weeks
Secondary outcome [3] 0 0
Elimination half-life of ZGN-440 to assess relationship to weight loss.
Timepoint [3] 0 0
Approximately 4 weeks

Eligibility
Key inclusion criteria
- Obese but otherwise healthy females

- Non-childbearing potential (surgically sterile, post-menopausal, or receiving
implanted or injectable contraceptive for at least 3 months)

- BMI = 30 and = 45 kg/m2

- Stable body weight during the past 2 months
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Use of weight loss agents in the past month

- History of eating disorder

- History of type 1 or type 2 diabetes mellitus

- Current smokers

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Clinics, Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

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 assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety,
and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01507077
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
J K Marjason, MD
Address 0 0
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
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