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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/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
The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for
certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly
subcutaneous injections for 12 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01666691
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/NCT01666691