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/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.
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
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 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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
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 whether multiple doses of ZGN-433 are safe and
effective.
Trial website
https://clinicaltrials.gov/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01372761