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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01372761




Registration number
NCT01372761
Ethics application status
Date submitted
8/06/2011
Date registered
14/06/2011
Date last updated
30/12/2011

Titles & IDs
Public title
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
Scientific title
Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers
Secondary ID [1] 0 0
ZAF-003AUS
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-433
Treatment: Drugs - Normal Saline

Placebo Comparator: Normal Saline -

Experimental: ZGN-433 -


Treatment: Drugs: ZGN-433
Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Treatment: Drugs: Normal Saline
Subjects will receive placebo or ZGN-433 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-433 for reduction of body weight in obese female volunteers. - Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
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-433 to assess relationship to weight loss.
Timepoint [2] 0 0
Approximately 4 weeks
Secondary outcome [3] 0 0
Elimination half-life of ZGN-433 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 = 50 kg/m2

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

- History of eating disorder

- History of gastric bypass surgery

- 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 whether multiple doses of ZGN-433 are safe and
effective.
Trial website
https://clinicaltrials.gov/show/NCT01372761
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

Summary results
Other publications