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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01666691




Registration number
NCT01666691
Ethics application status
Date submitted
8/08/2012
Date registered
16/08/2012
Date last updated
14/07/2016

Titles & IDs
Public title
An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects
Scientific title
Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks
Secondary ID [1] 0 0
ZAF-201
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 - Beloranib
Treatment: Drugs - Placebo

Placebo comparator: Placebo - ZGN-440 sterile diluent

Experimental: 0.3 mg Beloranib - 0.3 mg ZGN-440 for injectable suspension

Experimental: 0.6 mg Beloranib - 0.6 mg ZGN-440 for injectable suspension

Experimental: 1.2 mg Beloranib - 1.2 mg ZGN-440 for injectable suspension

Experimental: 2.4 mg Beloranib - 2.4 mg ZGN-440 for injectable suspension

Experimental: 3.2 mg Beloranib - 3.2 mg ZGN-440 for injectable suspension


Treatment: Drugs: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.

Treatment: Drugs: Placebo
Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
Timepoint [1] 0 0
Up to 26 weeks
Primary outcome [2] 0 0
Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440
Timepoint [2] 0 0
Up to 13 weeks
Secondary outcome [1] 0 0
Pharmacodynamics over a dose range of beloranib
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [2] 0 0
Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously
Timepoint [2] 0 0
Up to 12 weeks
Secondary outcome [3] 0 0
Apparent bioavailability over a dose range of beloranib
Timepoint [3] 0 0
Up to 12 weeks

Eligibility
Key inclusion criteria
* Obese volunteers weighing = 50 kg
* BMI = 30 and = 50 kg/m2
* Stable body weight during the past 2 months
* Type 2 diabetes mellitus is allowed
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Use of weight loss agents in the past month
* Current, clinically significant eating disorder
* Type 1 diabetes mellitus

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 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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Q-Pharm Clinics, Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Perth
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Perth

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01666691